Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-07 @ 10:44 PM
Study NCT ID:
NCT02805660
Status:
TERMINATED
Last Update Posted:
2021-04-06
First Post:
2016-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C523184', 'term': 'mocetinostat'}, {'id': 'C000613593', 'term': 'durvalumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'neskorikt@mirati.com', 'phone': '858-332-3552', 'title': 'Tavette Neskorik, Senior Director, Clinical Science', 'organization': 'Mirati Therapeutics'}, 'certainAgreement': {'otherDetails': 'PI can not disclose, discuss, or publish study results until final manuscript has been published.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was discontinued early because the Sponsor de-prioritized development of mocetinostat. The decision to stop was not due to any patient safety issues.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1: Dose Escalation - 50 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this phase.\n\nMocetinostat: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 5, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Phase 1: Dose Escalation - 70 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this phase.\n\nMocetinostat: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Phase 1: Dose Escalation - 90 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this phase.\n\nMocetinostat: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'deathsNumAffected': 9, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Phase 2: Combination Regimen - Cohort 1', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 18, 'seriousNumAtRisk': 18, 'deathsNumAffected': 5, 'seriousNumAffected': 6}, {'id': 'EG004', 'title': 'Phase 2: Combination Regimen - Cohort 2', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Phase 2: Combination Regimen - Cohort 3', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 23, 'seriousNumAtRisk': 23, 'deathsNumAffected': 14, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'Phase 2: Combination Regimen - Cohort 4', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 18, 'seriousNumAtRisk': 19, 'deathsNumAffected': 12, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hyperacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vestibular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Inappropriate antidiuretic hormone secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 1}, 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'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 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{'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) During the First 28-day Cycle of Combination Treatment In Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Dose Escalation - 50 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG001', 'title': 'Phase 1: Dose Escalation - 70 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG002', 'title': 'Phase 1: Dose Escalation - 90 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Toxicities were graded using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03. Any of the following events considered to be causally related to treatment with mocetinostat in combination with durvalumab that occurred during Phase 1 were considered a DLT:\n\n* Any Grade 4 immune-related adverse event (irAE)\n* Grade 3 or greater colitis\n* Grade 3 or greater noninfectious pneumonitis\n* Grade 2 pneumonitis that did not resolve to ≤ Grade 1 within 3 days of the initiation of maximal supportive care\n* Grade 3 irAE (excluding colitis or pneumonitis) that:\n\n * Did not resolve to Grade 2 within 3 days after onset of the event despite optimal medical management including systemic corticosteroids, or\n * Did not resolve to Grade ≤1 or Baseline within 14 days\n* Liver transaminase elevation \\>8×upper limit of normal (ULN) or total bilirubin \\>5×ULN\n* Grade 3 or greater non-irAE, except nausea, vomiting, anorexia, dehydration, or diarrhea', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DLT Evaluable Population - Participant must have either been on study for one full cycle and have received treatment with durvalumab and at least 9 of 12 scheduled mocetinostat doses (75%) in Cycle 1 or have experienced a DLT in Cycle 1.'}, {'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Dose Escalation - 50 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG001', 'title': 'Phase 1: Dose Escalation - 70 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG002', 'title': 'Phase 1: Dose Escalation - 90 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG003', 'title': 'Phase 2: Combination Regimen - Cohort 1', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG004', 'title': 'Phase 2: Combination Regimen - Cohort 2', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG005', 'title': 'Phase 2: Combination Regimen - Cohort 3', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG006', 'title': 'Phase 2: Combination Regimen - Cohort 4', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '52.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '6.7', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '31.9'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '9.5', 'groupId': 'OG005', 'lowerLimit': '1.2', 'upperLimit': '30.4'}, {'value': '23.1', 'groupId': 'OG006', 'lowerLimit': '5.0', 'upperLimit': '53.8'}]}]}], 'analyses': [{'pValue': '0.537', 'groupIds': ['OG003'], 'statisticalMethod': 'Exact Test', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'An exact test for single proportion was performed to test null hypothesis (H0): ORR \\<= 5% against alternative hypothesis (H1): ORR \\> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \\<= 27% against H1: ORR \\> 27% for Cohort 2.'}, {'pValue': '>0.999', 'groupIds': ['OG004'], 'statisticalMethod': 'Exact Test', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'An exact test for single proportion was performed to test null hypothesis (H0): ORR \\<= 5% against alternative hypothesis (H1): ORR \\> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \\<= 27% against H1: ORR \\> 27% for Cohort 2.'}, {'pValue': '0.283', 'groupIds': ['OG005'], 'statisticalMethod': 'Exact Test', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'An exact test for single proportion was performed to test null hypothesis (H0): ORR \\<= 5% against alternative hypothesis (H1): ORR \\> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \\<= 27% against H1: ORR \\> 27% for Cohort 2.'}, {'pValue': '0.025', 'groupIds': ['OG006'], 'statisticalMethod': 'Exact Test', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'An exact test for single proportion was performed to test null hypothesis (H0): ORR \\<= 5% against alternative hypothesis (H1): ORR \\> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \\<= 27% against H1: ORR \\> 27% for Cohort 2.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 10 months', 'description': 'Objective Response Rate (ORR) was defined as the number of participants documented to have a confirmed Complete Response (CR) or Partial Response (PR). Complete Response was defined as the complete disappearance of all target lesions with the exception of nodal disease. Partial Response was defined at least a 30% decrease in the sum of diameters of target measurable lesions. Responses were determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Participants without response data were counted as non-responders.\n\nInferential statistical analyses were conducted for Phase 2 only, as efficacy was not part of the Phase 1 objectives.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical Activity Evaluable Population - The Clinical Activity Evaluable Population was defined as all participants who had at least one on-study disease assessment or discontinued from treatment for progressive disease (PD).'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Dose Escalation - 50 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG001', 'title': 'Phase 1: Dose Escalation - 70 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG002', 'title': 'Phase 1: Dose Escalation - 90 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG003', 'title': 'Phase 2: Combination Regimen - Cohort 1', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG004', 'title': 'Phase 2: Combination Regimen - Cohort 2', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG005', 'title': 'Phase 2: Combination Regimen - Cohort 3', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG006', 'title': 'Phase 2: Combination Regimen - Cohort 4', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to 28 days after last dose of study treatment (up to a maximum of 125 weeks in phase 1 and a maximum of 92 weeks in phase 2)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - The Safety population was defined as all participants who received at least 1 dose of either mocetinostat or durvalumab.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Combination Regimen - Cohort 1', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG001', 'title': 'Phase 2: Combination Regimen - Cohort 2', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG002', 'title': 'Phase 2: Combination Regimen - Cohort 3', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG003', 'title': 'Phase 2: Combination Regimen - Cohort 4', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '115', 'comment': 'Due to a small number of participants and events, data was not estimable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '329', 'comment': 'Due to a small number of participants and events, data was not estimable.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to a small number of participants and events, data was not estimable.', 'groupId': 'OG003', 'lowerLimit': '230', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 10 months', 'description': "DR was defined as the time in days from date of the first documentation of objective response (Complete Response \\[CR\\] or Partial Response \\[PR\\]) to the first documentation of objective Progressive Disease (PD) or to death due to any cause in the absence of documented PD. DR was only calculated for the subgroup of participants who achieved a Best Overall Response of CR or PR and was presented for responses assessed by Investigator's assessment.\n\nData is displayed for Phase 2 only, as no participants experienced an objective response (CR or PR) during Phase 1.", 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical Activity Evaluable Population (Subgroup of Responders) - Duration of response was only calculated for the subgroup of participants achieving a CR or PR.'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate (CBR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Dose Escalation - 50 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG001', 'title': 'Phase 1: Dose Escalation - 70 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG002', 'title': 'Phase 1: Dose Escalation - 90 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG003', 'title': 'Phase 2: Combination Regimen - Cohort 1', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG004', 'title': 'Phase 2: Combination Regimen - Cohort 2', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG005', 'title': 'Phase 2: Combination Regimen - Cohort 3', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG006', 'title': 'Phase 2: Combination Regimen - Cohort 4', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 10 months', 'description': 'Clinical benefit rate (CBR) was defined as the number of participants documented to have a confirmed Complete Response (CR), Partial Response (PR), or Stable Disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Participants who were not be able to be assessed for response were counted as non-responders.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical Activity Evaluable Population - The Clinical Activity Evaluable Population was defined as all participants who had at least one on-study disease assessment or discontinued from treatment for progressive disease (PD).'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Dose Escalation - 50 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG001', 'title': 'Phase 1: Dose Escalation - 70 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG002', 'title': 'Phase 1: Dose Escalation - 90 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG003', 'title': 'Phase 2: Combination Regimen - Cohort 1', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG004', 'title': 'Phase 2: Combination Regimen - Cohort 2', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG005', 'title': 'Phase 2: Combination Regimen - Cohort 3', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG006', 'title': 'Phase 2: Combination Regimen - Cohort 4', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'comment': 'Due to a small number of participants and events, data was not estimable.', 'groupId': 'OG000', 'lowerLimit': '1.88', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to a small number of participants and events, data was not estimable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '1.51', 'upperLimit': '27.57'}, {'value': '3', 'groupId': 'OG003', 'lowerLimit': '2.01', 'upperLimit': '5.86'}, {'value': '4', 'comment': 'Due to a small number of participants and events, data was not estimable.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2', 'groupId': 'OG005', 'lowerLimit': '1.94', 'upperLimit': '14.57'}, {'value': '3', 'groupId': 'OG006', 'lowerLimit': '2.04', 'upperLimit': '9.57'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization until progressive disease or death due to any cause (up to 42 months)', 'description': 'Progression-free survival (PFS) was defined as the time from date of first study treatment to first Progressive Disease (PD) or death due to any cause in the absence of documented PD per RECIST v1.1', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population (mITT) - The mITT Population was defined as all participants who received treatment with both mocetinostat and durvalumab on this study.'}, {'type': 'SECONDARY', 'title': '1-Year Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Dose Escalation - 50 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG001', 'title': 'Phase 1: Dose Escalation - 70 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG002', 'title': 'Phase 1: Dose Escalation - 90 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG003', 'title': 'Phase 2: Combination Regimen - Cohort 1', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG004', 'title': 'Phase 2: Combination Regimen - Cohort 2', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG005', 'title': 'Phase 2: Combination Regimen - Cohort 3', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG006', 'title': 'Phase 2: Combination Regimen - Cohort 4', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.75'}, {'value': '0.38', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.81'}, {'value': '0.53', 'groupId': 'OG002', 'lowerLimit': '0.18', 'upperLimit': '0.80'}, {'value': '0.72', 'groupId': 'OG003', 'lowerLimit': '0.41', 'upperLimit': '0.89'}, {'value': '1.00', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '1.00'}, {'value': '0.52', 'groupId': 'OG005', 'lowerLimit': '0.31', 'upperLimit': '0.70'}, {'value': '0.50', 'groupId': 'OG006', 'lowerLimit': '0.23', 'upperLimit': '0.72'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population (mITT) - The mITT Population was defined as all participants who received treatment with both mocetinostat and durvalumab on this study.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Dose Escalation - 50 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG001', 'title': 'Phase 1: Dose Escalation - 70 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG002', 'title': 'Phase 1: Dose Escalation - 90 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG003', 'title': 'Phase 2: Combination Regimen - Cohort 1', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG004', 'title': 'Phase 2: Combination Regimen - Cohort 2', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG005', 'title': 'Phase 2: Combination Regimen - Cohort 3', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG006', 'title': 'Phase 2: Combination Regimen - Cohort 4', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '2.40', 'upperLimit': '32.99'}, {'value': '11', 'comment': 'Due to a small number of participants and events, data was not estimable.', 'groupId': 'OG001', 'lowerLimit': '7.17', 'upperLimit': 'NA'}, {'value': '16', 'groupId': 'OG002', 'lowerLimit': '3.49', 'upperLimit': '26.05'}, {'value': 'NA', 'comment': 'Due to a small number of participants and events, data was not estimable.', 'groupId': 'OG003', 'lowerLimit': '7.37', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to a small number of participants and events, data was not estimable.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '15', 'comment': 'Due to a small number of participants and events, data was not estimable.', 'groupId': 'OG005', 'lowerLimit': '7.73', 'upperLimit': 'NA'}, {'value': '14', 'groupId': 'OG006', 'lowerLimit': '5.07', 'upperLimit': '20.86'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of first study treatment until death due to any cause (up to 42 months)', 'description': 'OS was defined as the time from first dose of study treatment to the date of death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population (mITT) - The mITT Population was defined as all participants who received treatment with both mocetinostat and durvalumab on this study.'}, {'type': 'SECONDARY', 'title': 'Concentration of Mocetinistat in Blood Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Mocetinostat 50 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG001', 'title': 'Phase 1: Mocetinostat 70 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG002', 'title': 'Phase 1: Mocetinostat 90 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG003', 'title': 'Phase 1: Mocetinostat 40 mg', 'description': 'One participant in Phase 1 was de-escalated to 40 mg of mocetinostat.'}, {'id': 'OG004', 'title': 'Phase 2: Mocetinostat 70 mg', 'description': 'Participants in Phase 2 who received the recommended Phase 2 dose of 70 mg of mocetinostat.'}, {'id': 'OG005', 'title': 'Phase 2: Mocetinostat 50 mg', 'description': 'Six participants in Phase 2 were de-escalated to 50 mg of mocetinostat.'}], 'classes': [{'title': 'Cycle 1: Day 1 - pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and corresponding coefficient of variation could not be estimated as none of the participants had an evaluable result (i.e. above LOQ).', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '83.20', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '114.68', 'groupId': 'OG002'}, {'value': '39.65', 'spread': '175.97', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 1: Day 1 - 1 hour post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '19.85', 'spread': '441.16', 'groupId': 'OG000'}, {'value': '106.61', 'spread': '43.77', 'groupId': 'OG001'}, {'value': '92.56', 'spread': '143.96', 'groupId': 'OG002'}, {'value': '12.19', 'spread': '289.89', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 1: Day 1 - 3 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '33.53', 'spread': '111.21', 'groupId': 'OG000'}, {'value': '61.63', 'spread': '24.78', 'groupId': 'OG001'}, {'value': '55.27', 'spread': '53.19', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 1: Day 1 - 7 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '15.75', 'spread': '58.30', 'groupId': 'OG000'}, {'value': '20.92', 'spread': '27.20', 'groupId': 'OG001'}, {'value': '33.89', 'spread': '45.21', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 1: Day 15 - pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.36', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '95.06', 'groupId': 'OG001'}, {'value': '3.84', 'spread': '202.26', 'groupId': 'OG002'}, {'value': '1.92', 'spread': '127.96', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 1: Day 15 - 1 hour post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '102.67', 'spread': '7.17', 'groupId': 'OG000'}, {'value': '22.30', 'spread': '14646.88', 'groupId': 'OG001'}, {'value': '18.32', 'spread': '1297.79', 'groupId': 'OG002'}, {'value': '10.86', 'spread': '330.59', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 2: Day 1 - pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.72', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).', 'groupId': 'OG000'}, {'value': '0.85', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).', 'groupId': 'OG001'}, {'value': '1.22', 'spread': '83.65', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and corresponding coefficient of variation could not be estimated as none of the participants had an evaluable result (i.e. above LOQ).', 'groupId': 'OG003'}, {'value': '1.16', 'spread': '91.63', 'groupId': 'OG004'}, {'value': '0.68', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).', 'groupId': 'OG005'}]}]}, {'title': 'Cycle 2: Day 1 - 1 hour post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '75.11', 'spread': '25.53', 'groupId': 'OG000'}, {'value': '49.30', 'spread': '86.19', 'groupId': 'OG001'}, {'value': '2.45', 'spread': '83.60', 'groupId': 'OG002'}, {'value': '0.72', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).', 'groupId': 'OG003'}, {'value': '14.65', 'spread': '396.22', 'groupId': 'OG004'}, {'value': '105.00', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).', 'groupId': 'OG005'}]}]}, {'title': 'Cycle 3: Day 1 - pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.89', 'spread': '44.73', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and corresponding coefficient of variation could not be estimated as none of the participants had an evaluable result (i.e. above LOQ).', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and corresponding coefficient of variation could not be estimated as none of the participants had an evaluable result (i.e. above LOQ).', 'groupId': 'OG003'}, {'value': '4.08', 'spread': '238.84', 'groupId': 'OG004'}, {'value': '0.92', 'spread': '40.65', 'groupId': 'OG005'}]}]}, {'title': 'Cycle 3: Day 1 - 1 hour post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '22.73', 'spread': '301.01', 'groupId': 'OG000'}, {'value': '92.40', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).', 'groupId': 'OG001'}, {'value': '0.73', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).', 'groupId': 'OG003'}, {'value': '14.39', 'spread': '319.34', 'groupId': 'OG004'}, {'value': '25.12', 'spread': '378.13', 'groupId': 'OG005'}]}]}, {'title': 'Cycle 7: Day 1 - pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and corresponding coefficient of variation could not be estimated as none of the participants had an evaluable result (i.e. above LOQ).', 'groupId': 'OG000'}, {'value': '0.85', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).', 'groupId': 'OG001'}, {'value': '1.35', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).', 'groupId': 'OG002'}, {'value': '0.65', 'spread': '35.19', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and corresponding coefficient of variation could not be estimated as none of the participants had an evaluable result (i.e. above LOQ).', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose, 1, 3, and 7 hours post-dose, Cycle 1 Day 15 pre-dose and 1 hour post-dose, Cycle 2 Day 1 pre-dose and 1 hour post-dose, Cycle 3 Day 1 pre-dose and 1 hour post-dose and Cycle 7 Day 1 pre-dose (each cycle is 28 days)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Evaluable Population - The Pharmacokinetic (PK) Evaluable Population was defined as all patients who had PK concentration data collected for mocetinostat or durvalumab. Participants were combined for analysis of mocetinistat concentrations, as prespecified in the analysis shells, based on the actual dose of mocetinistat received in each phase of the study. Pharmacokinetic measures at 3 and 7 hours post dose on Cycle 1 Day 1 were only planned for Phase 1.'}, {'type': 'SECONDARY', 'title': 'Concentration of Durvalumab in Blood Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab', 'description': 'Participants who received durvalumab during the study.'}], 'classes': [{'title': 'Cycle 1: Day 1 - pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '259.18', 'spread': '334.86', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1: Day 1 - end of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '385779.56', 'spread': '36.49', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1: Day 15 - pre-Mocetinostat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '102925.55', 'spread': '40.05', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2: Day 1 - pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44140.86', 'spread': '130.83', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3: Day 1 - pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72049.14', 'spread': '91.22', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4: Day 1 - pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '101852.34', 'spread': '89.01', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4: Day 1 - end of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '365307.01', 'spread': '81.59', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 7: Day 1 - pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '130335.14', 'spread': '70.34', 'groupId': 'OG000'}]}]}, {'title': '90 days after last dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12304.13', 'spread': '501.74', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': "Cycle 1 Day 1 pre-dose + end of infusion, Cycle 1 Day 15 pre-mocetinostat dose, Cycle 2 Day 1 pre-dose, Cycle 3 Day 1 pre-dose, Cycle 4 Day 1 pre-dose + end of infusion, Cycle 7 Day 1 pre-dose + 90 days after participant's last dose (Up to max 133 weeks)", 'description': 'Plasma concentration of Durvalumab was evaluated. All participants received the same Durvalumab dose regardless of Mocetinistat dose group.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Evaluable Population - The Pharmacokinetic (PK) Evaluable Population was defined as all patients who had PK concentration data collected for mocetinostat or durvalumab. Participants were combined for analysis of mocetinistat concentrations, as prespecified in the analysis shells, based on the actual dose of mocetinistat received in each phase of the study. Pharmacokinetic measures at 3 and 7 hours post dose on Cycle 1 Day 1 were only planned for Phase 1.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Presence of Anti-Drug Antibody (ADA) in the Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Dose Escalation - 50 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG001', 'title': 'Phase 1: Dose Escalation - 70 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG002', 'title': 'Phase 1: Dose Escalation - 90 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG003', 'title': 'Phase 2: Combination Regimen - Cohort 1', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG004', 'title': 'Phase 2: Combination Regimen - Cohort 2', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG005', 'title': 'Phase 2: Combination Regimen - Cohort 3', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG006', 'title': 'Phase 2: Combination Regimen - Cohort 4', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 10 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ADA Evaluable Population - The ADA Evaluable Population was defined as all patients who received at least 1 dose of either durvalumab or mocetinostat for whom ADA results were available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Tumor Expression of Programmed Cell Death Ligand 1 (PD-L1) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Dose Escalation - 50 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG001', 'title': 'Phase 1: Dose Escalation - 70 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG002', 'title': 'Phase 1: Dose Escalation - 90 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'OG003', 'title': 'Phase 2: Combination Regimen - Cohort 1', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG004', 'title': 'Phase 2: Combination Regimen - Cohort 2', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG005', 'title': 'Phase 2: Combination Regimen - Cohort 3', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'OG006', 'title': 'Phase 2: Combination Regimen - Cohort 4', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}], 'classes': [{'title': 'No/Low PD-L1 Expression', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}]}, {'title': 'High PD-L1 Expression', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population (mITT) - The mITT Population was defined as all participants who received treatment with both mocetinostat and durvalumab on this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1: Dose Escalation - 50 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'FG001', 'title': 'Phase 1: Dose Escalation - 70 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'FG002', 'title': 'Phase 1: Dose Escalation - 90 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'FG003', 'title': 'Phase 2: Combination Regimen - Cohort 1', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70mg).'}, {'id': 'FG004', 'title': 'Phase 2: Combination Regimen - Cohort 2', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'FG005', 'title': 'Phase 2: Combination Regimen - Cohort 3', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'FG006', 'title': 'Phase 2: Combination Regimen - Cohort 4', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '23'}, {'groupId': 'FG006', 'numSubjects': '19'}]}, {'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': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '23'}, {'groupId': 'FG006', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Study terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '83', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1: Dose Escalation - 50 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'BG001', 'title': 'Phase 1: Dose Escalation - 70 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'BG002', 'title': 'Phase 1: Dose Escalation - 90 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.\n\nMocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.'}, {'id': 'BG003', 'title': 'Phase 2: Combination Regimen - Cohort 1', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'BG004', 'title': 'Phase 2: Combination Regimen - Cohort 2', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'BG005', 'title': 'Phase 2: Combination Regimen - Cohort 3', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'BG006', 'title': 'Phase 2: Combination Regimen - Cohort 4', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.\n\nDurvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.\n\nMocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', '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': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '33', 'groupId': 'BG007'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '50', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '42', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '41', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '76', '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': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', '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': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', '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': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '67', 'groupId': 'BG007'}]}, {'title': 'More than one race', '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': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '83', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoking History', 'classes': [{'title': 'Non-smoker', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}]}]}, {'title': 'Current Smoker', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}]}]}, {'title': 'Former Smoker', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '52', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-10', 'size': 1156394, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-11T09:34', 'hasProtocol': True}, {'date': '2017-10-30', 'size': 708308, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-01-08T13:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'whyStopped': 'The study was discontinued early because the Sponsor de-prioritized development of mocetinostat. The decision to stop was not due to any patient safety issues.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-10', 'studyFirstSubmitDate': '2016-06-10', 'resultsFirstSubmitDate': '2020-12-11', 'studyFirstSubmitQcDate': '2016-06-17', 'lastUpdatePostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-10', 'studyFirstPostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) During the First 28-day Cycle of Combination Treatment In Phase 1', 'timeFrame': '28 days', 'description': 'Toxicities were graded using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03. Any of the following events considered to be causally related to treatment with mocetinostat in combination with durvalumab that occurred during Phase 1 were considered a DLT:\n\n* Any Grade 4 immune-related adverse event (irAE)\n* Grade 3 or greater colitis\n* Grade 3 or greater noninfectious pneumonitis\n* Grade 2 pneumonitis that did not resolve to ≤ Grade 1 within 3 days of the initiation of maximal supportive care\n* Grade 3 irAE (excluding colitis or pneumonitis) that:\n\n * Did not resolve to Grade 2 within 3 days after onset of the event despite optimal medical management including systemic corticosteroids, or\n * Did not resolve to Grade ≤1 or Baseline within 14 days\n* Liver transaminase elevation \\>8×upper limit of normal (ULN) or total bilirubin \\>5×ULN\n* Grade 3 or greater non-irAE, except nausea, vomiting, anorexia, dehydration, or diarrhea'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 10 months', 'description': 'Objective Response Rate (ORR) was defined as the number of participants documented to have a confirmed Complete Response (CR) or Partial Response (PR). Complete Response was defined as the complete disappearance of all target lesions with the exception of nodal disease. Partial Response was defined at least a 30% decrease in the sum of diameters of target measurable lesions. Responses were determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Participants without response data were counted as non-responders.\n\nInferential statistical analyses were conducted for Phase 2 only, as efficacy was not part of the Phase 1 objectives.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Experiencing Treatment-Emergent Adverse Events', 'timeFrame': 'Day 1 to 28 days after last dose of study treatment (up to a maximum of 125 weeks in phase 1 and a maximum of 92 weeks in phase 2)'}, {'measure': 'Duration of Response (DR)', 'timeFrame': 'Up to approximately 10 months', 'description': "DR was defined as the time in days from date of the first documentation of objective response (Complete Response \\[CR\\] or Partial Response \\[PR\\]) to the first documentation of objective Progressive Disease (PD) or to death due to any cause in the absence of documented PD. DR was only calculated for the subgroup of participants who achieved a Best Overall Response of CR or PR and was presented for responses assessed by Investigator's assessment.\n\nData is displayed for Phase 2 only, as no participants experienced an objective response (CR or PR) during Phase 1."}, {'measure': 'Clinical Benefit Rate (CBR)', 'timeFrame': 'Up to approximately 10 months', 'description': 'Clinical benefit rate (CBR) was defined as the number of participants documented to have a confirmed Complete Response (CR), Partial Response (PR), or Stable Disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Participants who were not be able to be assessed for response were counted as non-responders.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Randomization until progressive disease or death due to any cause (up to 42 months)', 'description': 'Progression-free survival (PFS) was defined as the time from date of first study treatment to first Progressive Disease (PD) or death due to any cause in the absence of documented PD per RECIST v1.1'}, {'measure': '1-Year Survival Rate', 'timeFrame': '1 year'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From date of first study treatment until death due to any cause (up to 42 months)', 'description': 'OS was defined as the time from first dose of study treatment to the date of death due to any cause.'}, {'measure': 'Concentration of Mocetinistat in Blood Plasma', 'timeFrame': 'Cycle 1 Day 1 pre-dose, 1, 3, and 7 hours post-dose, Cycle 1 Day 15 pre-dose and 1 hour post-dose, Cycle 2 Day 1 pre-dose and 1 hour post-dose, Cycle 3 Day 1 pre-dose and 1 hour post-dose and Cycle 7 Day 1 pre-dose (each cycle is 28 days)'}, {'measure': 'Concentration of Durvalumab in Blood Plasma', 'timeFrame': "Cycle 1 Day 1 pre-dose + end of infusion, Cycle 1 Day 15 pre-mocetinostat dose, Cycle 2 Day 1 pre-dose, Cycle 3 Day 1 pre-dose, Cycle 4 Day 1 pre-dose + end of infusion, Cycle 7 Day 1 pre-dose + 90 days after participant's last dose (Up to max 133 weeks)", 'description': 'Plasma concentration of Durvalumab was evaluated. All participants received the same Durvalumab dose regardless of Mocetinistat dose group.'}, {'measure': 'Number of Participants With the Presence of Anti-Drug Antibody (ADA) in the Blood', 'timeFrame': 'Up to approximately 10 months'}, {'measure': 'Number of Participants With Tumor Expression of Programmed Cell Death Ligand 1 (PD-L1) at Baseline', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MGCD0103', 'MEDI4736', 'Mocetinostat', 'Durvalumab', 'HDAC Inhibitor', 'PD-L1 Inhibitor', 'Phase 1', 'Phase 2', 'Metastatic Solid Tumor', 'Non-small cell lung cancer', 'immunotherapy', 'checkpoint inhibitor'], 'conditions': ['Advanced Cancer']}, 'descriptionModule': {'briefSummary': 'Mocetinostat (MGCD0103) is an orally administered HDAC inhibitor. Durvalumab (MEDI4736) is a human monoclonal antibody that is an inhibitor of the Programmed Cell Death Ligand (or PD-L1). Durvalumab is also known as a checkpoint inhibitor.\n\nThis study is evaluating the combination regimen of mocetinostat and durvalumab in participants with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Phase 1-Diagnosis of advanced or metastatic solid tumor; Phase 2-Diagnosis of NSCLC\n* Not amenable to treatment with curative intent\n* Adequate bone marrow and organ function\n\nExclusion Criteria:\n\n* Impaired heart function\n* Uncontrolled tumor in the brain\n* Other active cancer'}, 'identificationModule': {'nctId': 'NCT02805660', 'briefTitle': 'Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mirati Therapeutics Inc.'}, 'officialTitle': 'A Phase 1/2 Study of HDAC Inhibitor, Mocetinostat, in Combination With PD-L1 Inhibitor, Durvalumab, in Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '0103-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1: Dose Escalation - 50 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.', 'interventionNames': ['Drug: Mocetinostat - 50 mg', 'Drug: Durvalumab - 1500 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1: Dose Escalation - 70 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.', 'interventionNames': ['Drug: Mocetinostat - 70 mg', 'Drug: Durvalumab - 1500 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1: Dose Escalation - 90 mg', 'description': 'The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.', 'interventionNames': ['Drug: Mocetinostat - 90 mg', 'Drug: Durvalumab - 1500 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2: Combination Regimen - Cohort 1', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.', 'interventionNames': ['Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg)', 'Drug: Durvalumab - 1500 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2: Combination Regimen - Cohort 2', 'description': 'Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.', 'interventionNames': ['Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg)', 'Drug: Durvalumab - 1500 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2: Combination Regimen - Cohort 3', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.', 'interventionNames': ['Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg)', 'Drug: Durvalumab - 1500 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2: Combination Regimen - Cohort 4', 'description': 'Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.', 'interventionNames': ['Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg)', 'Drug: Durvalumab - 1500 mg']}], 'interventions': [{'name': 'Mocetinostat - 50 mg', 'type': 'DRUG', 'otherNames': ['MGCD0103'], 'description': 'Participants received mocetinostat three times weekly as an oral capsule.', 'armGroupLabels': ['Phase 1: Dose Escalation - 50 mg']}, {'name': 'Mocetinostat - 70 mg', 'type': 'DRUG', 'otherNames': ['MGCD0103'], 'description': 'Participants received mocetinostat three times weekly as an oral capsule.', 'armGroupLabels': ['Phase 1: Dose Escalation - 70 mg']}, {'name': 'Mocetinostat - 90 mg', 'type': 'DRUG', 'otherNames': ['MGCD0103'], 'description': 'Participants received mocetinostat three times weekly as an oral capsule.', 'armGroupLabels': ['Phase 1: Dose Escalation - 90 mg']}, {'name': 'Mocetinostat - Recommended Phase 2 Dose (70 mg)', 'type': 'DRUG', 'otherNames': ['MGCD0103'], 'description': 'Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).', 'armGroupLabels': ['Phase 2: Combination Regimen - Cohort 1', 'Phase 2: Combination Regimen - Cohort 2', 'Phase 2: Combination Regimen - Cohort 3', 'Phase 2: Combination Regimen - Cohort 4']}, {'name': 'Durvalumab - 1500 mg', 'type': 'DRUG', 'otherNames': ['MEDI4736'], 'description': 'Participants received durvalumab as an intravenous infusion every 4 weeks.', 'armGroupLabels': ['Phase 1: Dose Escalation - 50 mg', 'Phase 1: Dose Escalation - 70 mg', 'Phase 1: Dose Escalation - 90 mg', 'Phase 2: Combination Regimen - Cohort 1', 'Phase 2: Combination Regimen - Cohort 2', 'Phase 2: Combination Regimen - Cohort 3', 'Phase 2: Combination Regimen - Cohort 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Southern Cancer Center, PC', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'David Geffen School of Medicine at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32503', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Woodlands Medical Specialists - Pensacola', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center of Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University Health System', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Unniversity of Minnesota Masonic Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Mary Crowley Cancer Research Centers', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76210', 'city': 'Denton', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Denton South', 'geoPoint': {'lat': 33.21484, 'lon': -97.13307}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology-Plano West', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Cancer Specialists', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '22601', 'city': 'Winchester', 'state': 'Virginia', 'country': 'United States', 'facility': 'Shenandoah Oncology - Winchester', 'geoPoint': {'lat': 39.18566, 'lon': -78.16333}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mirati Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}