Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-21 @ 1:16 PM
Study NCT ID:
NCT03611556
Status:
COMPLETED
Last Update Posted:
2023-10-03
First Post:
2018-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613593', 'term': 'durvalumab'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '+1-877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca Clinical study Information Center'}, 'certainAgreement': {'otherDetails': 'MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Dose escalation phase: Participants not enrolled in oleclumab 750 mg cohort. Dose expansion phase: Outcomes of mFOLFOX cohorts not included as enrollment was not opened. Non-compartmental PK data analysis were planned to be performed from each dose cohort if data allowed, but as sparse PK samples were collected, no non-compartmental PK parameters were calculated. Consequently, PK concentration time data only have been reported.'}}, 'adverseEventsModule': {'timeFrame': 'Day 1 through 172.1 weeks (maximum observed duration)', 'eventGroups': [{'id': 'EG000', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 7, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 7, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; fluorouracil \\[5-FU\\] 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; 5-FU 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 8, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Dose-expansion, Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 60, 'seriousNumAtRisk': 62, 'deathsNumAffected': 47, 'seriousNumAffected': 34}, {'id': 'EG005', 'title': 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 36, 'seriousNumAtRisk': 38, 'deathsNumAffected': 32, 'seriousNumAffected': 24}, {'id': 'EG006', 'title': 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 70, 'seriousNumAtRisk': 70, 'deathsNumAffected': 53, 'seriousNumAffected': 37}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 37, 'numAffected': 22}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 25, 'numAffected': 14}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 36, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Early satiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 33, 'numAffected': 30}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 60, 'numAffected': 25}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 54, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Splenic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Localised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 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'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; fluorouracil \\[5-FU\\] 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; 5-FU 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Any TESAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 65.7 weeks (maximum observed duration)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Dose-limiting Toxicities (DLTs) in Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; fluorouracil \\[5-FU\\] 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; 5-FU 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 to 28 days after the first dose of study drugs', 'description': 'DLT: Any study drug related Grade (G)3 or higher toxicity including: any G4 immune-mediated AEs, \\>=G3 colitis/pneumonitis/interstitial lung disease (ILD), \\>=G3 nausea/vomiting/diarrhea that does not resolve to G2 or less within 3 days of maximal supportive care (MSC), G2 pneumonitis/ILD that does not resolve within 7 days of initiation of MSC, G4 anemia, G3 anemia with clinical sequelae/requires \\>2 units of red blood cells transfusion, G4 thrombocytopenia/neutropenia \\>=7 days, G3/4 thrombocytopenia with \\>=G3 hemorrhage, G4 febrile neutropenia (FN), G3 FN lasting \\>=5 days while receiving MSC, isolated G3 liver transaminase elevation (LTE)/ isolated G3 total bilirubin (TBL) that does not downgrade to G1 or less within 14 days of onset, isolated G4 LTE or TBL, elevated aspartate aminotransferase/alanine aminotransferase \\>3×upper limit of normal (ULN) and concurrent TBL \\>2×ULN without cholestasis or alternative explanations, any other toxicity judged as a DLT by Dose Escalation Committee.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The DLT-evaluable population included all participants enrolled in the dose-escalation phase who received all planned doses of study drugs during the DLT evaluation period and completed the safety follow-up through the DLT evaluation period or experienced any DLT during the DLT-evaluation period.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; fluorouracil \\[5-FU\\] 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; 5-FU 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Dyspnoea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Dyspnoea exertional', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Temperature intolerance', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 65.7 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal vital signs (temperature, blood pressure, pulse rate, and respiratory rate) reported as TEAEs are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs in Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; fluorouracil \\[5-FU\\] 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; 5-FU 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'title': 'Atrial fibrillation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Tachycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Atrioventricular block', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 65.7 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal ECG parameters reported as TEAEs are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; fluorouracil \\[5-FU\\] 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; 5-FU 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'title': 'Anaemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Neutropenia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Thrombocytopenia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hypothyroidism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Alanine aminotransferase increased', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Aspartate aminotransferase increased', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Blood alkaline phosphatase increased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Blood bilirubin increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Blood creatinine increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Blood glucose decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'International normalised ratio increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocyte count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophil count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Platelet count decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'White blood cell count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Hypoalbuminaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hypocalcaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hypokalaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Hypomagnesaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hyponatraemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Hypophosphataemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Proteinuria', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hyperthyroidism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Amylase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Gamma-glutamyltransferase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Lipase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 65.7 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-expansion, Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000', 'lowerLimit': '18.2', 'upperLimit': '41.9'}, {'value': '21.1', 'groupId': 'OG001', 'lowerLimit': '9.6', 'upperLimit': '37.3'}, {'value': '32.9', 'groupId': 'OG002', 'lowerLimit': '22.1', 'upperLimit': '45.1'}]}]}], 'analyses': [{'pValue': '0.3614', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.0', 'ciLowerLimit': '-27.6', 'ciUpperLimit': '12.1', 'pValueComment': 'Nominal P-value for comparison of treatment groups obtained from Cochran-Mantel-Haenszel-test was stratified by cluster of differentiation 73 (CD73) level.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': '80% Confidence Interval 2-Sided: -20.9 to 5.2'}, {'pValue': '0.6503', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.8', 'ciLowerLimit': '-13.2', 'ciUpperLimit': '20.7', 'pValueComment': 'Nominal P-value for comparison of treatment groups obtained from Cochran-Mantel-Haenszel-test was stratified by CD73 level.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': '80% Confidence Interval 2-Sided: -7.4 to 15.0'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)', 'description': 'The OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions (TLs) and non-target lesions (NTLs), any pathological lymph nodes (target and non-target) must have reduction in short axis \\< 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters (SoD) of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to treat (ITT) population included all participants who were randomized and received any study drugs and were analyzed according to randomized treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With TEAEs and TESAEs in Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-expansion, Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}]}, {'title': 'Any TESAEs', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 172.1 weeks (maximum observed duration)', 'description': 'An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-expansion, Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'title': 'Hypothermia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Dyspnoea', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Dyspnoea exertional', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Orthostatic hypotension', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 172.1 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal vital signs (temperature, blood pressure, pulse rate, and respiratory rate) reported as TEAEs are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal ECG Parameters Reported as TEAEs in Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-expansion, Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'title': 'Supraventricular tachycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Tachycardia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 172.1 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal ECG parameters reported as TEAEs are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-expansion, Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'title': 'Anaemia', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'Febrile neutropenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Leukopenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Neutropenia', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Thrombocytopenia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Thrombocytosis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hyperthyroidism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Hypothyroidism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Hypertransaminasaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Alanine aminotransferase decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Alanine aminotransferase increased', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Amylase increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Aspartate aminotransferase increased', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Blood albumin decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blood alkaline phosphatase increased', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Blood bilirubin increased', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Blood creatinine increased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Blood glucose increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blood lactate dehydrogenase increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Blood magnesium decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blood oestrogen decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Gamma-glutamyltransferase increased', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Haemoglobin decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'International normalised ratio increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Lipase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Liver function test increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocyte count decreased', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophil count', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophil count decreased', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Platelet count decreased', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Troponin I increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'White blood cell count decreased', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'White blood cell count increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperglycaemia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Hyperkalaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypoalbuminaemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Hypocalcaemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Hypoglycaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hypokalaemia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Hypomagnesaemia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Hyponatraemia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Hypophosphataemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypovolaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Iron deficiency', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Type 2 diabetes mellitus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Proteinuria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 172.1 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With OR According to RECIST v1.1 in Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; fluorouracil \\[5-FU\\] 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; 5-FU 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'comment': 'There was zero responder in this cohort, so 95% confidence interval (CI) could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '57.9'}, {'value': '0', 'comment': 'There was zero responder in this cohort, so 95% CI could not be calculated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12.5', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '52.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Days -28 to -1) through 24.5 months (maximum observed duration)', 'description': 'The OR is defined as best overall response of confirmed CR or confirmed PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions, any pathological lymph nodes (target and non-target) must have reduction in short axis \\< 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Disease Control (DC) According to RECIST v1.1 in Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; fluorouracil \\[5-FU\\] 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; 5-FU 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': '81.6'}, {'value': '71.4', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '96.3'}, {'value': '66.7', 'groupId': 'OG002', 'lowerLimit': '9.4', 'upperLimit': '99.2'}, {'value': '62.5', 'groupId': 'OG003', 'lowerLimit': '24.5', 'upperLimit': '91.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Days -28 to -1) through 24.5 months (maximum observed duration)', 'description': 'The DC is defined as confirmed CR, PR, or stable disease (SD) (maintained for \\>=8 weeks). The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis \\<10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from date of first documentation. The SD is defined as neither sufficient shrinkage of TLs to qualify for PR nor sufficient increase of TLs to qualify for progressive disease (PD), taking as reference the smallest SoD while on study, and no new lesions. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Percentage of participants with DC is reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Overall Survival Events in Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-expansion, Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.260', 'ciLowerLimit': '0.790', 'ciUpperLimit': '1.983', 'estimateComment': 'Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.750', 'ciLowerLimit': '0.498', 'ciUpperLimit': '1.131', 'estimateComment': 'Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)', 'description': 'The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed using the Kaplan-Meier method. The number of participants with overall survival events (deaths) is reported.', 'unitOfMeasure': 'Participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Overall Survival in Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-expansion, Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '13.2'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '11.5'}, {'value': '12.9', 'groupId': 'OG002', 'lowerLimit': '10.1', 'upperLimit': '15.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)', 'description': 'The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed using the Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Progression-free Survival Events According to RECIST v1.1 in Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-expansion, Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.160', 'ciLowerLimit': '0.726', 'ciUpperLimit': '1.837', 'estimateComment': 'Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.719', 'ciLowerLimit': '0.468', 'ciUpperLimit': '1.105', 'estimateComment': 'Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)', 'description': 'Progression-free survival (PFS) is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant received subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in sum of the diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of sum of the diameters, or unequivocal progression of existing non-target lesions, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST v1.1 assessment. The PFS is assessed using the Kaplan-Meier method. The number of participants with PFS events is reported.', 'unitOfMeasure': 'Participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival According to RECIST v1.1 in Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-expansion, Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '9.0'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '7.5'}, {'value': '7.5', 'groupId': 'OG002', 'lowerLimit': '5.5', 'upperLimit': '10.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)', 'description': 'The PFS is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant received subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in sum of the diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of sum of the diameters, or unequivocal progression of existing non-target lesions, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST v1.1 assessment. The PFS is assessed using the Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR) According to RECIST v1.1 in Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-expansion, Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'comment': 'Upper limit of 95% CI was not calculated because an insufficient number of participants had event.', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': 'NA'}, {'value': '12.9', 'comment': 'Upper limit of 95% CI was not calculated because an insufficient number of participants had event.', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': 'NA'}, {'value': '9.5', 'groupId': 'OG002', 'lowerLimit': '5.7', 'upperLimit': '12.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)', 'description': 'The DoR is defined as the time from the first documentation of an OR until the first documentation of a PD or death due to any cause, whichever occurs first. The OR is defined as best overall response of confirmed CR or PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis \\< 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. The DoR is assessed using the Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment. The DoR is assessed for only those participants who had OR.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DC According to RECIST v1.1 in Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-expansion, Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.1', 'groupId': 'OG000', 'lowerLimit': '53.0', 'upperLimit': '77.7'}, {'value': '73.7', 'groupId': 'OG001', 'lowerLimit': '56.9', 'upperLimit': '86.6'}, {'value': '75.7', 'groupId': 'OG002', 'lowerLimit': '64.0', 'upperLimit': '85.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)', 'description': 'The DC is defined as confirmed CR, PR, or stable disease (SD) (maintained for \\>=8 weeks). The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis \\<10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from date of first documentation. The SD is defined as neither sufficient shrinkage of TLs to qualify for PR nor sufficient increase of TLs to qualify for PD, taking as reference the smallest SoD while on study, and no new lesions. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Percentage of participants with DC is reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With OR According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine + Nab-paclitaxel: CD73 Level = High', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = High', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = High', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'Gemcitabine + Nab-paclitaxel: CD73 Level = Low', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = Low', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = Low', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000', 'lowerLimit': '12.6', 'upperLimit': '38.8'}, {'value': '22.2', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '42.3'}, {'value': '31.4', 'groupId': 'OG002', 'lowerLimit': '19.1', 'upperLimit': '45.9'}, {'value': '43.8', 'groupId': 'OG003', 'lowerLimit': '19.8', 'upperLimit': '70.1'}, {'value': '18.2', 'groupId': 'OG004', 'lowerLimit': '2.3', 'upperLimit': '51.8'}, {'value': '36.8', 'groupId': 'OG005', 'lowerLimit': '16.3', 'upperLimit': '61.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-25.2', 'ciUpperLimit': '21.9', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.5', 'ciLowerLimit': '-12.6', 'ciUpperLimit': '27.0', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.6', 'ciLowerLimit': '-58.3', 'ciUpperLimit': '13.9', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.9', 'ciLowerLimit': '-39.1', 'ciUpperLimit': '26.6', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)', 'description': 'The OR is defined as best overall response of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis \\<10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The OR is assessed by cluster of differentiation 73 (CD73) expression level either low or high at baseline. The CD73 low is defined as no CD73 expression in tumor cells or \\<50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in \\>=50% of tumor cells.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment. Here, "number of participants analyzed" (N) signified those participants who had high or low levels of CD73.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Overall Survival Events by CD73 Expression at Baseline in Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine + Nab-paclitaxel: CD73 Level = High', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = High', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = High', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'Gemcitabine + Nab-paclitaxel: CD73 Level = Low', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = Low', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = Low', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.173', 'ciLowerLimit': '0.676', 'ciUpperLimit': '1.985', 'estimateComment': 'Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.605', 'ciLowerLimit': '0.377', 'ciUpperLimit': '0.968', 'estimateComment': 'Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.549', 'ciLowerLimit': '0.622', 'ciUpperLimit': '3.917', 'estimateComment': 'Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.472', 'ciLowerLimit': '0.638', 'ciUpperLimit': '3.576', 'estimateComment': 'Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)', 'description': 'The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed by CD73 expression level either low or high at baseline using the Kaplan-Meier method. The CD73 low is defined as no CD73 expression in tumor cells or \\<50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in \\>=50% of tumor cells. The number of participants with overall survival events (deaths) is reported.', 'unitOfMeasure': 'Participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment. Here, "number of participants analyzed" (N) signified those participants who had high or low levels of CD73.'}, {'type': 'SECONDARY', 'title': 'Overall Survival by CD73 Expression at Baseline in Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine + Nab-paclitaxel: CD73 Level = High', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = High', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = High', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'Gemcitabine + Nab-paclitaxel: CD73 Level = Low', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = Low', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = Low', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '12.2'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '9.7'}, {'value': '12.1', 'groupId': 'OG002', 'lowerLimit': '8.6', 'upperLimit': '15.0'}, {'value': '22.2', 'groupId': 'OG003', 'lowerLimit': '10.2', 'upperLimit': '33.6'}, {'value': '16.0', 'groupId': 'OG004', 'lowerLimit': '5.7', 'upperLimit': '22.6'}, {'value': '16.1', 'groupId': 'OG005', 'lowerLimit': '10.3', 'upperLimit': '21.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)', 'description': 'The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed by CD73 expression level either low or high at baseline using the Kaplan-Meier method. The CD73 low is defined as no CD73 expression in tumor cells or \\<50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in \\>=50% of tumor cells.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment. Here, "number of participants analyzed" (N) signified those participants who had high or low levels of CD73.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Progression-free Survival Events According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine + Nab-paclitaxel: CD73 Level = High', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = High', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = High', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'Gemcitabine + Nab-paclitaxel: CD73 Level = Low', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = Low', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = Low', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.004', 'ciLowerLimit': '0.584', 'ciUpperLimit': '1.693', 'estimateComment': 'Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.598', 'ciLowerLimit': '0.366', 'ciUpperLimit': '0.973', 'estimateComment': 'Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.933', 'ciLowerLimit': '0.716', 'ciUpperLimit': '5.437', 'estimateComment': 'Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.374', 'ciLowerLimit': '0.550', 'ciUpperLimit': '3.707', 'estimateComment': 'Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)', 'description': 'PFS: Time from randomization until first documentation of PD/death due to any cause, whichever occurred first, regardless of whether participant received subsequent anticancer treatment prior to progression. PD:\\>=20% increase in SoD of TLs and an absolute increase of \\>= 5 mm of SoD/unequivocal progression of existing NTLs/appearance of new lesion. Participants who had no documented progression and were still alive at the time of analysis were censored at time of latest date of assessment from their last evaluable RECIST v1.1 assessment. PFS is assessed by CD73 expression level either low/high at baseline using Kaplan-Meier method. CD73 low: No CD73 expression in tumor cells/\\<50% of tumor cells with 2+/3+ intensity. CD73 high: CD73 expression with 2+/3+ intensity in \\>=50% of tumor cells. Number of participants with PFS events is reported.', 'unitOfMeasure': 'Participants with event', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment. Here, "number of participants analyzed" (N) signified those participants who had high or low levels of CD73.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine + Nab-paclitaxel: CD73 Level = High', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = High', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = High', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'Gemcitabine + Nab-paclitaxel: CD73 Level = Low', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel: CD73 Level = Low', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel: CD73 Level = Low', 'description': 'In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '7.4'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '6.3'}, {'value': '5.5', 'groupId': 'OG002', 'lowerLimit': '4.4', 'upperLimit': '9.3'}, {'value': '10.5', 'comment': 'Upper limit of 95% CI was not calculated because an insufficient number of participants had event.', 'groupId': 'OG003', 'lowerLimit': '6.9', 'upperLimit': 'NA'}, {'value': '7.6', 'groupId': 'OG004', 'lowerLimit': '3.3', 'upperLimit': '11.2'}, {'value': '10.9', 'groupId': 'OG005', 'lowerLimit': '5.7', 'upperLimit': '13.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)', 'description': 'The PFS is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant receives subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at time of analysis were censored at time of latest date of assessment from their last evaluable RECIST v1.1 assessment. PFS is assessed by CD73 expression level either low/high at baseline using Kaplan-Meier method. CD73 low: No CD73 expression in tumor cells/\\<50% of tumor cells with 2+/3+ intensity. CD73 high: CD73 expression with 2+/3+ intensity in \\>=50% of tumor cells.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment. Here, "number of participants analyzed" (N) signified those participants who had high or low levels of CD73.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Anti-drug Antibodies (ADA) to Oleclumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; fluorouracil \\[5-FU\\] 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; 5-FU 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'title': 'ADA positive at baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'ADA positive post-baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Persistent Positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Transient Positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Treatment-boosted ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 172.1 weeks (Pre-dose on Cycle [C] 1 Day [D] 1, C2D1, C3D1, Day 1 of every 3 cycles starting with C5, through 12 weeks post last dose of oleclumab)', 'description': 'Number of participants with positive ADA to oleclumab are reported. Persistent positive is defined as positive at \\>= 2 post-baseline assessments (with \\>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at \\>= 2 post-baseline assessments (with \\<16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA positive titer that was boosted to a 4-fold or higher level following drug administration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ADA evaluable oleclumab population included all participants who received oleclumab, analyzed according to the treatment they actually received, and who had a non-missing baseline ADA result and at least one non-missing post-baseline ADA result.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive ADA to Durvalumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; fluorouracil \\[5-FU\\] 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; 5-FU 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'title': 'ADA positive at baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'ADA positive post-baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Persistent Positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Transient Positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Treatment-boosted ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through 128 weeks (Pre-dose on C1D1, C2D1, C3D1, Day 1 of every 3 cycles starting with C5, through 12 weeks post last dose of durvalumab)', 'description': 'Number of participants with positive ADA to durvalumab are reported. Persistent positive is defined as positive at \\>= 2 post-baseline assessments (with \\>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at \\>= 2 post-baseline assessments (with \\<16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA positive titer that was boosted to a 4-fold or higher level following drug administration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ADA evaluable durvalumab population included all participants who received durvalumab, analyzed according to the treatment they actually received, and who had a non-missing baseline ADA result and at least one non-missing post-baseline ADA result.'}, {'type': 'SECONDARY', 'title': 'Serum Concentrations of Oleclumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '70', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; fluorouracil \\[5-FU\\] 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; 5-FU 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'classes': [{'title': 'C1D1 (EOI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '70', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '297.6', 'spread': '25.70', 'groupId': 'OG000'}, {'value': '710.2', 'spread': '21.42', 'groupId': 'OG001'}, {'value': '412.7', 'spread': '11.12', 'groupId': 'OG002'}, {'value': '734.6', 'spread': '41.01', 'groupId': 'OG003'}, {'value': '704.4', 'spread': '30.28', 'groupId': 'OG004'}, {'value': '725.9', 'spread': '34.69', 'groupId': 'OG005'}]}]}, {'title': 'C3D1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '57', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '128.6', 'spread': '10.00', 'groupId': 'OG000'}, {'value': '211.5', 'spread': '73.40', 'groupId': 'OG001'}, {'value': '134.3', 'spread': '141.5', 'groupId': 'OG002'}, {'value': '368.9', 'spread': '2.461', 'groupId': 'OG003'}, {'value': '164.8', 'spread': '324.1', 'groupId': 'OG004'}, {'value': '226.8', 'spread': '70.41', 'groupId': 'OG005'}]}]}, {'title': 'C3D1 (EOI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '57', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Per sponsor convention three observations \\> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.', 'groupId': 'OG000'}, {'value': '870.3', 'spread': '21.86', 'groupId': 'OG001'}, {'value': '571.1', 'spread': '15.75', 'groupId': 'OG002'}, {'value': '1181', 'spread': '24.97', 'groupId': 'OG003'}, {'value': '893.0', 'spread': '30.66', 'groupId': 'OG004'}, {'value': '894.4', 'spread': '39.22', 'groupId': 'OG005'}]}]}, {'title': 'C5D1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Per sponsor convention three observations \\> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.', 'groupId': 'OG000'}, {'value': '73.19', 'spread': '130.2', 'groupId': 'OG001'}, {'value': '235.7', 'spread': '27.68', 'groupId': 'OG003'}, {'value': '85.99', 'spread': '192.0', 'groupId': 'OG004'}, {'value': '116.4', 'spread': '54.0', 'groupId': 'OG005'}]}]}, {'title': 'C5D1 (EOI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Per sponsor convention three observations \\> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.', 'groupId': 'OG000'}, {'value': '948.3', 'spread': '44.90', 'groupId': 'OG001'}, {'value': '1057', 'spread': '14.88', 'groupId': 'OG003'}, {'value': '852.8', 'spread': '24.77', 'groupId': 'OG004'}, {'value': '753.2', 'spread': '41.32', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Ten minutes (mins) (± 5 mins) post end of infusion (EOI), approximately 1 hour (+ 15 mins) after start of infusion on C1D1, C3D1, and C5D1; and pre-dose on C3D1 and C5D1', 'description': 'Serum concentrations of oleclumab are reported.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) evaluable oleclumab population included all participants who received at least one dose of oleclumab and who had at least one reportable PK concentration. Here, number analyzed (n) denotes those participants who were analyzed for the specified time points.'}, {'type': 'SECONDARY', 'title': 'Serum Concentrations of Durvalumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; 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Otherwise, the statistics were not calculated at the time point.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Per sponsor convention three observations \\> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.', 'groupId': 'OG004'}]}]}, {'title': 'Gemcitabine C4D1 (EOI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Per sponsor convention three observations \\> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. 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Otherwise, the statistics were not calculated at the time point.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Per sponsor convention three observations \\> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Per sponsor convention three observations \\> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Per sponsor convention three observations \\> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Per sponsor convention three observations \\> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.', 'groupId': 'OG004'}]}]}, {'title': 'C4D1 (EOI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Per sponsor convention three observations \\> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.', 'groupId': 'OG000'}, {'value': '1474', 'spread': '96.12', 'groupId': 'OG001'}, {'value': '1825', 'spread': '178.1', 'groupId': 'OG002'}, {'value': '1445', 'spread': '145.8', 'groupId': 'OG003'}, {'value': '1747', 'spread': '99.26', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Ten mins (± 5 mins) post EOI, approximately 30-40 mins after start of infusion on C1D1 and C4D1; and pre-dose on C4D1', 'description': 'Plasma concentrations of nab-paclitaxel are reported.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK evaluable nab-paclitaxel population included all participants who received at least one dose of nab-paclitaxel and who had at least one reportable PK concentration. Here, number of participants analyzed (N) indicates those participants who had adequate PK samples. Here, number analyzed (n) denotes those participants who were analyzed for the specified time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with first-line (1L) metastatic disease received intravenous (IV) infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then every 4 weeks (Q4W) in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'FG001', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'FG002', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'description': 'Participants with second-line (2L) metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; fluorouracil \\[5-FU\\] 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'FG003', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; 5-FU 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'FG004', 'title': 'Dose-expansion, Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'FG005', 'title': 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'FG006', 'title': 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '62'}, {'groupId': 'FG005', 'numSubjects': '38'}, {'groupId': 'FG006', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '62'}, {'groupId': 'FG005', 'numSubjects': '38'}, {'groupId': 'FG006', 'numSubjects': '70'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '47'}, {'groupId': 'FG005', 'numSubjects': '32'}, {'groupId': 'FG006', 'numSubjects': '53'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '4'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '12'}]}, {'type': 'Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 25 participants were treated in dose escalation part of this study. A total of 188 participants were randomised in dose expansion part of this study of which 170 participants were treated (18 participants were randomised but not treated). Results are presented for 195 treated participants only.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}, {'value': '38', 'groupId': 'BG005'}, {'value': '70', 'groupId': 'BG006'}, {'value': '195', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'BG001', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'BG002', 'title': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'description': 'Participants with second-line (2L) metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; fluorouracil \\[5-FU\\] 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'BG003', 'title': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; 5-FU 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'BG004', 'title': 'Dose-expansion, Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'BG005', 'title': 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'BG006', 'title': 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + Nab-paclitaxel', 'description': 'Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '59.6', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '67.0', 'spread': '14.9', 'groupId': 'BG002'}, {'value': '64.8', 'spread': '4.8', 'groupId': 'BG003'}, {'value': '65.6', 'spread': '8.0', 'groupId': 'BG004'}, {'value': '62.5', 'spread': '11.1', 'groupId': 'BG005'}, {'value': '62.9', 'spread': '8.3', 'groupId': 'BG006'}, {'value': '63.8', 'spread': '9.1', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}, {'value': '89', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}, {'value': '106', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '69', 'groupId': 'BG006'}, {'value': '191', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}, {'value': '64', 'groupId': 'BG006'}, {'value': '171', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-24', 'size': 25144928, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-20T03:35', 'hasProtocol': True}, {'date': '2022-08-01', 'size': 6323044, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-20T03:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-08', 'studyFirstSubmitDate': '2018-05-18', 'resultsFirstSubmitDate': '2023-07-20', 'studyFirstSubmitQcDate': '2018-07-26', 'lastUpdatePostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-08', 'studyFirstPostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase', 'timeFrame': 'Day 1 through 65.7 weeks (maximum observed duration)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.'}, {'measure': 'Number of Participants With Dose-limiting Toxicities (DLTs) in Dose Escalation Phase', 'timeFrame': 'From Day 1 to 28 days after the first dose of study drugs', 'description': 'DLT: Any study drug related Grade (G)3 or higher toxicity including: any G4 immune-mediated AEs, \\>=G3 colitis/pneumonitis/interstitial lung disease (ILD), \\>=G3 nausea/vomiting/diarrhea that does not resolve to G2 or less within 3 days of maximal supportive care (MSC), G2 pneumonitis/ILD that does not resolve within 7 days of initiation of MSC, G4 anemia, G3 anemia with clinical sequelae/requires \\>2 units of red blood cells transfusion, G4 thrombocytopenia/neutropenia \\>=7 days, G3/4 thrombocytopenia with \\>=G3 hemorrhage, G4 febrile neutropenia (FN), G3 FN lasting \\>=5 days while receiving MSC, isolated G3 liver transaminase elevation (LTE)/ isolated G3 total bilirubin (TBL) that does not downgrade to G1 or less within 14 days of onset, isolated G4 LTE or TBL, elevated aspartate aminotransferase/alanine aminotransferase \\>3×upper limit of normal (ULN) and concurrent TBL \\>2×ULN without cholestasis or alternative explanations, any other toxicity judged as a DLT by Dose Escalation Committee.'}, {'measure': 'Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Escalation Phase', 'timeFrame': 'Day 1 through 65.7 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal vital signs (temperature, blood pressure, pulse rate, and respiratory rate) reported as TEAEs are reported.'}, {'measure': 'Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs in Dose Escalation Phase', 'timeFrame': 'Day 1 through 65.7 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal ECG parameters reported as TEAEs are reported.'}, {'measure': 'Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Escalation Phase', 'timeFrame': 'Day 1 through 65.7 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported.'}, {'measure': 'Percentage of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Dose Expansion Phase', 'timeFrame': 'Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)', 'description': 'The OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions (TLs) and non-target lesions (NTLs), any pathological lymph nodes (target and non-target) must have reduction in short axis \\< 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters (SoD) of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With TEAEs and TESAEs in Dose Expansion Phase', 'timeFrame': 'Day 1 through 172.1 weeks (maximum observed duration)', 'description': 'An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.'}, {'measure': 'Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Expansion Phase', 'timeFrame': 'Day 1 through 172.1 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal vital signs (temperature, blood pressure, pulse rate, and respiratory rate) reported as TEAEs are reported.'}, {'measure': 'Number of Participants With Abnormal ECG Parameters Reported as TEAEs in Dose Expansion Phase', 'timeFrame': 'Day 1 through 172.1 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal ECG parameters reported as TEAEs are reported.'}, {'measure': 'Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Expansion Phase', 'timeFrame': 'Day 1 through 172.1 weeks (maximum observed duration)', 'description': 'Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported.'}, {'measure': 'Percentage of Participants With OR According to RECIST v1.1 in Dose Escalation Phase', 'timeFrame': 'Baseline (Days -28 to -1) through 24.5 months (maximum observed duration)', 'description': 'The OR is defined as best overall response of confirmed CR or confirmed PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions, any pathological lymph nodes (target and non-target) must have reduction in short axis \\< 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported.'}, {'measure': 'Percentage of Participants With Disease Control (DC) According to RECIST v1.1 in Dose Escalation Phase', 'timeFrame': 'Baseline (Days -28 to -1) through 24.5 months (maximum observed duration)', 'description': 'The DC is defined as confirmed CR, PR, or stable disease (SD) (maintained for \\>=8 weeks). The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis \\<10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from date of first documentation. The SD is defined as neither sufficient shrinkage of TLs to qualify for PR nor sufficient increase of TLs to qualify for progressive disease (PD), taking as reference the smallest SoD while on study, and no new lesions. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Percentage of participants with DC is reported.'}, {'measure': 'Number of Participants With Overall Survival Events in Dose Expansion Phase', 'timeFrame': 'Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)', 'description': 'The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed using the Kaplan-Meier method. The number of participants with overall survival events (deaths) is reported.'}, {'measure': 'Overall Survival in Dose Expansion Phase', 'timeFrame': 'Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)', 'description': 'The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed using the Kaplan-Meier method.'}, {'measure': 'Number of Participants With Progression-free Survival Events According to RECIST v1.1 in Dose Expansion Phase', 'timeFrame': 'Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)', 'description': 'Progression-free survival (PFS) is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant received subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in sum of the diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of sum of the diameters, or unequivocal progression of existing non-target lesions, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST v1.1 assessment. The PFS is assessed using the Kaplan-Meier method. The number of participants with PFS events is reported.'}, {'measure': 'Progression-free Survival According to RECIST v1.1 in Dose Expansion Phase', 'timeFrame': 'Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)', 'description': 'The PFS is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant received subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in sum of the diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of sum of the diameters, or unequivocal progression of existing non-target lesions, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST v1.1 assessment. The PFS is assessed using the Kaplan-Meier method.'}, {'measure': 'Duration of Response (DoR) According to RECIST v1.1 in Dose Expansion Phase', 'timeFrame': 'Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)', 'description': 'The DoR is defined as the time from the first documentation of an OR until the first documentation of a PD or death due to any cause, whichever occurs first. The OR is defined as best overall response of confirmed CR or PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis \\< 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. The DoR is assessed using the Kaplan-Meier method.'}, {'measure': 'Percentage of Participants With DC According to RECIST v1.1 in Dose Expansion Phase', 'timeFrame': 'Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)', 'description': 'The DC is defined as confirmed CR, PR, or stable disease (SD) (maintained for \\>=8 weeks). The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis \\<10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from date of first documentation. The SD is defined as neither sufficient shrinkage of TLs to qualify for PR nor sufficient increase of TLs to qualify for PD, taking as reference the smallest SoD while on study, and no new lesions. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Percentage of participants with DC is reported.'}, {'measure': 'Percentage of Participants With OR According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase', 'timeFrame': 'Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)', 'description': 'The OR is defined as best overall response of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis \\<10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The OR is assessed by cluster of differentiation 73 (CD73) expression level either low or high at baseline. The CD73 low is defined as no CD73 expression in tumor cells or \\<50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in \\>=50% of tumor cells.'}, {'measure': 'Number of Participants With Overall Survival Events by CD73 Expression at Baseline in Dose Expansion Phase', 'timeFrame': 'Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)', 'description': 'The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed by CD73 expression level either low or high at baseline using the Kaplan-Meier method. The CD73 low is defined as no CD73 expression in tumor cells or \\<50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in \\>=50% of tumor cells. The number of participants with overall survival events (deaths) is reported.'}, {'measure': 'Overall Survival by CD73 Expression at Baseline in Dose Expansion Phase', 'timeFrame': 'Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)', 'description': 'The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed by CD73 expression level either low or high at baseline using the Kaplan-Meier method. The CD73 low is defined as no CD73 expression in tumor cells or \\<50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in \\>=50% of tumor cells.'}, {'measure': 'Number of Participants With Progression-free Survival Events According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase', 'timeFrame': 'Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)', 'description': 'PFS: Time from randomization until first documentation of PD/death due to any cause, whichever occurred first, regardless of whether participant received subsequent anticancer treatment prior to progression. PD:\\>=20% increase in SoD of TLs and an absolute increase of \\>= 5 mm of SoD/unequivocal progression of existing NTLs/appearance of new lesion. Participants who had no documented progression and were still alive at the time of analysis were censored at time of latest date of assessment from their last evaluable RECIST v1.1 assessment. PFS is assessed by CD73 expression level either low/high at baseline using Kaplan-Meier method. CD73 low: No CD73 expression in tumor cells/\\<50% of tumor cells with 2+/3+ intensity. CD73 high: CD73 expression with 2+/3+ intensity in \\>=50% of tumor cells. Number of participants with PFS events is reported.'}, {'measure': 'Progression-free Survival According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase', 'timeFrame': 'Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)', 'description': 'The PFS is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant receives subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at time of analysis were censored at time of latest date of assessment from their last evaluable RECIST v1.1 assessment. PFS is assessed by CD73 expression level either low/high at baseline using Kaplan-Meier method. CD73 low: No CD73 expression in tumor cells/\\<50% of tumor cells with 2+/3+ intensity. CD73 high: CD73 expression with 2+/3+ intensity in \\>=50% of tumor cells.'}, {'measure': 'Number of Participants With Positive Anti-drug Antibodies (ADA) to Oleclumab', 'timeFrame': 'Day 1 through 172.1 weeks (Pre-dose on Cycle [C] 1 Day [D] 1, C2D1, C3D1, Day 1 of every 3 cycles starting with C5, through 12 weeks post last dose of oleclumab)', 'description': 'Number of participants with positive ADA to oleclumab are reported. Persistent positive is defined as positive at \\>= 2 post-baseline assessments (with \\>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at \\>= 2 post-baseline assessments (with \\<16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA positive titer that was boosted to a 4-fold or higher level following drug administration.'}, {'measure': 'Number of Participants With Positive ADA to Durvalumab', 'timeFrame': 'Day 1 through 128 weeks (Pre-dose on C1D1, C2D1, C3D1, Day 1 of every 3 cycles starting with C5, through 12 weeks post last dose of durvalumab)', 'description': 'Number of participants with positive ADA to durvalumab are reported. Persistent positive is defined as positive at \\>= 2 post-baseline assessments (with \\>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at \\>= 2 post-baseline assessments (with \\<16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA positive titer that was boosted to a 4-fold or higher level following drug administration.'}, {'measure': 'Serum Concentrations of Oleclumab', 'timeFrame': 'Ten minutes (mins) (± 5 mins) post end of infusion (EOI), approximately 1 hour (+ 15 mins) after start of infusion on C1D1, C3D1, and C5D1; and pre-dose on C3D1 and C5D1', 'description': 'Serum concentrations of oleclumab are reported.'}, {'measure': 'Serum Concentrations of Durvalumab', 'timeFrame': 'Ten mins (± 5 mins) post EOI, approximately 1 hour (+ 15 mins) after start of infusion on C1D1 and C5D1; and pre-dose on C2D1 and C5D1', 'description': 'Serum concentrations of durvalumab are reported.'}, {'measure': "Plasma Concentrations of Gemcitabine and Metabolite 2',2'-Difluorodeoxyuridine (dFdU)", 'timeFrame': 'Ten mins (± 5 mins) post EOI, approximately 30-40 mins after start of infusion on C1D1 and C4D1; and pre-dose on C4D1', 'description': 'Plasma concentrations of gemcitabine and metabolite dFdU are reported.'}, {'measure': 'Plasma Concentrations of Nab-paclitaxel', 'timeFrame': 'Ten mins (± 5 mins) post EOI, approximately 30-40 mins after start of infusion on C1D1 and C4D1; and pre-dose on C4D1', 'description': 'Plasma concentrations of nab-paclitaxel are reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MEDI9447', 'oleclumab', 'immunotherapy', 'pancreatic cancer', 'durvalumab'], 'conditions': ['Carcinoma', 'Metastatic Pancreatic Adenocarcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6070C00005&attachmentIdentifier=0fb0e4a6-ef94-4658-9a6d-b9d2f77f571f&fileName=d6070c00005-csp-amendment-3-Redacted.pdf&versionIdentifier=', 'label': 'CSP redacted'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6070C00005&attachmentIdentifier=636c01ef-f3da-4eec-b9de-de1fe3ac4864&fileName=d6070c00005-sap-ed-3-Redacted.pdf&versionIdentifier=', 'label': 'SAP redacted'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6070C00005&attachmentIdentifier=1f662c2d-1eb8-4c56-9b23-87d6bb71975d&fileName=d6070c00005-study-synopsis-Redacted-PDF-A.pdf&versionIdentifier=', 'label': 'CSR Synopsis redacted'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety, tolerability, and antitumor activity of oleclumab (MEDI9447) in combination with or without durvalumab plus chemotherapy in participants with metastatic pancreatic cancer.', 'detailedDescription': 'This is a Phase 1b/2, multicenter, open-label, dose-escalation, and dose-expansion study to assess the safety, preliminary antitumor activity, immunogenicity, and pharmacokinetics (PK) of oleclumab with or without durvalumab in combination with chemotherapy administered in participants with metastatic pancreatic ductal adenocarcinoma (PDAC). Participants with previously untreated metastatic PDAC (first-line \\[1L\\] metastatic PDAC) will be enrolled in Cohort A. Participants with metastatic PDAC previously treated with gemcitabine-based chemotherapy (without exposure to 5-fluorouracil \\[5-FU\\], capecitabine, or oxaliplatin; second-line \\[2L\\] metastatic PDAC) will be enrolled in Cohort B. The study consists of 2 parts, dose escalation (Part 1) and dose expansion (Part 2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '101 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>= 18\n2. Written and signed informed consent must be obtained\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n4. Weight \\>= 35 kg\n5. Participants must have histologically or cytologically, confirmed pancreatic adenocarcinoma:\n\n Cohort A: Participants with previously untreated metastatic pancreatic adenocarcinoma (1L metastatic disease) not previously treated with systemic therapies Cohort B: Participants with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-based chemotherapy (without exposure to 5-FU, capecitabine, oxaliplatin) 2L metastatic disease\n6. Participants must have at least 1 measurable lesion according to RECIST v1.1\n7. All Participants must consent to providing archival tumor specimens.\n\nExclusion Criteria:\n\n1. Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled first dose of study treatment.\n2. Prior receipt of any immune-related therapy\n3. Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed.\n4. Participants with a history of venous thrombosis within the past 3 months\n5. Participants with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 3 months prior to start of treatment\n6. Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment\n7. Other invasive malignancy within 2 years\n8. Any history of leptomeningeal disease or cord compression\n9. Current or prior use of immunosuppressive medication within 14 days prior to the first dose.'}, 'identificationModule': {'nctId': 'NCT03611556', 'briefTitle': 'MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) With or Without Durvalumab in Combination With Chemotherapy in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma', 'orgStudyIdInfo': {'id': 'D6070C00005'}, 'secondaryIdInfos': [{'id': 'D6070C00005', 'type': 'OTHER_GRANT', 'domain': 'MedImmune, LLC'}, {'id': '2018-001028-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + nab-paclitaxel', 'description': 'Participants with 1L metastatic disease will receive intravenous (IV) infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then every 4 weeks (Q4W) in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.', 'interventionNames': ['Drug: Oleclumab', 'Drug: Durvalumab', 'Drug: Gemcitabine', 'Drug: Nab-paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel', 'description': 'Participants with 1L metastatic disease will receive IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.', 'interventionNames': ['Drug: Oleclumab', 'Drug: Durvalumab', 'Drug: Gemcitabine', 'Drug: Nab-paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease will receive IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; 5-FU 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.', 'interventionNames': ['Drug: Oleclumab', 'Drug: Durvalumab', 'Drug: Oxaliplatin', 'Drug: Folinic acid', 'Drug: 5-FU']}, {'type': 'EXPERIMENTAL', 'label': 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX', 'description': 'Participants with 2L metastatic disease will receive IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m\\^2 IV; folinic acid 400 mg/m\\^2 IV; 5-FU 400 mg/m\\^2 IV bolus followed by 2400 mg/m\\^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.', 'interventionNames': ['Drug: Oleclumab', 'Drug: Durvalumab', 'Drug: Oxaliplatin', 'Drug: Folinic acid', 'Drug: 5-FU']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dose-expansion, Gemcitabine + nab-paclitaxel', 'description': 'Participants with 1L metastatic disease will receive IV infusions of chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.', 'interventionNames': ['Drug: Gemcitabine', 'Drug: Nab-paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + nab-paclitaxel', 'description': 'Participants with 1L metastatic disease will receive IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.', 'interventionNames': ['Drug: Oleclumab', 'Drug: Gemcitabine', 'Drug: Nab-paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel', 'description': 'Participants with 1L metastatic disease will receive IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m\\^2 and nab-paclitaxel 125 mg/m\\^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.', 'interventionNames': ['Drug: Oleclumab', 'Drug: Durvalumab', 'Drug: Gemcitabine', 'Drug: Nab-paclitaxel']}], 'interventions': [{'name': 'Oleclumab', 'type': 'DRUG', 'otherNames': ['MEDI9447'], 'description': 'Participants will receive IV infusion of oleclumab as stated in arm description.', 'armGroupLabels': ['Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + nab-paclitaxel', 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel', 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX', 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel', 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + nab-paclitaxel']}, {'name': 'Durvalumab', 'type': 'DRUG', 'otherNames': ['MEDI4736'], 'description': 'Participants will receive IV infusion of durvalumab as stated in arm description.', 'armGroupLabels': ['Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + nab-paclitaxel', 'Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel', 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX', 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Participants will receive IV infusion of gemcitabine as stated in arm description.', 'armGroupLabels': ['Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + nab-paclitaxel', 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel', 'Dose-expansion, Gemcitabine + nab-paclitaxel', 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel', 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + nab-paclitaxel']}, {'name': 'Nab-paclitaxel', 'type': 'DRUG', 'description': 'Participants will receive IV infusion of nab-paclitaxel as stated in arm description.', 'armGroupLabels': ['Dose-escalation, Oleclumab 1500 mg + Durvalumab + Gemcitabine + nab-paclitaxel', 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel', 'Dose-expansion, Gemcitabine + nab-paclitaxel', 'Dose-expansion, Oleclumab 3000 mg + Durvalumab + Gemcitabine + nab-paclitaxel', 'Dose-expansion, Oleclumab 3000 mg + Gemcitabine + nab-paclitaxel']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['Modified FOLFOX (oxaliplatin, folinic acid, and 5-FU)'], 'description': 'Participants will receive IV infusion of oxaliplatin as stated in arm description.', 'armGroupLabels': ['Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX']}, {'name': 'Folinic acid', 'type': 'DRUG', 'otherNames': ['Modified FOLFOX (oxaliplatin, folinic acid, and 5-FU)'], 'description': 'Participants will receive IV infusion of folinic acid as stated in arm description.', 'armGroupLabels': ['Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX']}, {'name': '5-FU', 'type': 'DRUG', 'otherNames': ['Modified FOLFOX (oxaliplatin, folinic acid, and 5-FU)'], 'description': 'Participants will receive IV infusion of 5-FU as stated in arm description.', 'armGroupLabels': ['Dose-escalation, Oleclumab 1500 mg + Durvalumab + mFOLFOX', 'Dose-escalation, Oleclumab 3000 mg + Durvalumab + mFOLFOX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 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