Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-03-03 @ 2:20 PM
Study NCT ID:
NCT02166905
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2014-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613752', 'term': 'epacadostat'}, {'id': 'C019531', 'term': 'poly ICLC'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chong.wang@roswellpark.org', 'phone': '716-845-2300', 'title': 'Katy Wang', 'organization': 'Roswell Park Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase I (CDX-1401, Poly ICLC, and a Fixed Daily Dose of INCB024360 )', 'description': 'Patients will receive a fixed intracutaneous dose of DEC205mAb-NY-ESO-1 fusion protein (CDX-1401) (Day 1) given with subcutaneous adjuvant poly-ICLC (Day 1 and Day 2) for each 28 day cycle for a total of 5 cycles; and Cohort 1 patient enrollment will begin INCB024360 at a fixed daily dose of BID orally', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Phase II 2a (CDX-1401, Poly ICLC)', 'description': 'Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, without IDO1 inhibitor INCB024360 in phase IIb.\n\nDEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection\n\nEpacadostat: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPharmacological Study: Correlative studies\n\nPoly ICLC: Given SC', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 14, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Phase II 2b (CDX-1401, Poly ICLC With INCB024360)', 'description': 'Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, with IDO1 inhibitor INCB024360 in phase IIb.\n\nDEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection\n\nEpacadostat: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPharmacological Study: Correlative studies\n\nPoly ICLC: Given SC', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Phase II 3 (Exploratory Cohort)', 'description': '4 cycles of sirolimus in combination with DEC205mAb-NY-ESO-01 fusion protein (CDX-1401) with adjuvant poly-ICLC', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Early satiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Injection site discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Injection site discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 11, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0.'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Determine the Safety and Evaluate Toxicity of Fixed Doses for Phase I Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I (CDX-1401, Poly ICLC, and a Fixed Daily Dose of INCB024360 )', 'description': 'Patients will receive a fixed intracutaneous dose of DEC205mAb-NY-ESO-1 fusion protein (CDX-1401) (Day 1) given with subcutaneous adjuvant poly-ICLC (Day 1 and Day 2) for each 28 day cycle for a total of 5 cycles; and Cohort 1 patient enrollment will begin INCB024360 at a fixed daily dose (300mg ) of BID orally'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'To determine the safety of fixed doses of DEC205mAb-NY-ESO-1 fusion protein with adjuvant poly-ICLC given as a vaccine in combination with INCB024360 300mg, number of Participants with Dose Limiting Toxicities is reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS) Based on Immune Related Response Criteria (irRC) for Phase II Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase IIb arm1 (CDX-1401, Poly ICLC, IDO1 Without Inhibitor INCB024360)', 'description': 'DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.\n\nAdjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles'}, {'id': 'OG001', 'title': 'Phase IIb arm2 (CDX-1401, Poly ICLC, With IDO1 Inhibitor INCB024360)', 'description': 'DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.\n\nAdjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles\n\n\\+ INCB024360 (Oral) : 300 mg BID for a total of 7 cycles'}, {'id': 'OG002', 'title': 'Phase IIb Arm 3 (Exploratory Cohort. Enrollment at Roswell Park Site ONLY. )', 'description': 'DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.\n\nAdjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles\n\n\\+ Sirolimus: 4 cycles of 4 mg/day for 2 weeks followed by 2 weeks off'}], 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000', 'lowerLimit': '0.52', 'upperLimit': '0.91'}, {'value': '0.54', 'groupId': 'OG001', 'lowerLimit': '0.29', 'upperLimit': '0.73'}, {'value': '0.50', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.88'}]}]}], 'analyses': [{'pValue': '0.177', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.4', 'ciLowerLimit': '0.1', 'ciUpperLimit': '1.2', 'estimateComment': 'Reference=arm 1', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'Percentage of Participants with Progression Free Survival Using irRC Criteria for Phase II Patients are reported. irRC criteria disease progression is defined as at least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 weeks apart.', 'unitOfMeasure': 'Proportion of participants w/o Progress', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Progression free survival rates (proportion) at 6 months are reported.'}, {'type': 'PRIMARY', 'title': 'To Evaluate Toxicity as Defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I (CDX-1401, Poly ICLC, and a Fixed Daily Dose of INCB024360 )', 'description': 'Patients will receive a fixed intracutaneous dose of DEC205mAb-NY-ESO-1 fusion protein (CDX-1401) (Day 1) given with subcutaneous adjuvant poly-ICLC (Day 1 and Day 2) for each 28 day cycle for a total of 5 cycles; and Cohort 1 patient enrollment will begin INCB024360 at a fixed daily dose of BID orally'}, {'id': 'OG001', 'title': 'Arm II 2a (CDX-1401, Poly ICLC, Without IDO1 Inhibitor INCB024360)', 'description': 'Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, without IDO1 inhibitor INCB024360 in phase IIb.\n\nDEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection\n\nEpacadostat: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPharmacological Study: Correlative studies\n\nPoly ICLC: Given SC'}, {'id': 'OG002', 'title': 'Arm II 2b (CDX-1401, Poly ICLC, With IDO1 Inhibitor INCB024360)', 'description': 'Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, with IDO1 inhibitor INCB024360 in phase IIb.\n\nDEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection\n\nEpacadostat: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPharmacological Study: Correlative studies\n\nPoly ICLC: Given SC'}, {'id': 'OG003', 'title': 'Phase IIb Arm 3 (Exploratory Cohort )', 'description': '4 cycles of sirolimus in combination with DEC205mAb-NY-ESO-01 fusion protein (CDX-1401) with adjuvant poly-ICLC'}], 'classes': [{'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Other Adverse Events', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'All patients enrolled in this study will be eligible for the analysis of toxicity. The toxicity rate will be estimated using a one-sided, 95%, exact binomial confidence interval (Clopper-Pearson).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I (CDX-1401, Poly ICLC, and a Fixed Daily Dose of INCB024360 )', 'description': 'Patients will receive a fixed intracutaneous dose of DEC205mAb-NY-ESO-1 fusion protein (CDX-1401) (Day 1) given with subcutaneous adjuvant poly-ICLC (Day 1 and Day 2) for each 28 day cycle for a total of 5 cycles; and Cohort 1 patient enrollment will begin INCB024360 at a fixed daily dose of BID orally'}, {'id': 'OG001', 'title': 'Arm II 2a (CDX-1401, Poly ICLC, Without IDO1 Inhibitor INCB024360)', 'description': 'Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, without IDO1 inhibitor INCB024360 in phase IIb.\n\nDEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection\n\nEpacadostat: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPharmacological Study: Correlative studies\n\nPoly ICLC: Given SC'}, {'id': 'OG002', 'title': 'Arm II 2b (CDX-1401, Poly ICLC, With IDO1 Inhibitor INCB024360)', 'description': 'Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, with IDO1 inhibitor INCB024360 in phase IIb.\n\nDEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection\n\nEpacadostat: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPharmacological Study: Correlative studies\n\nPoly ICLC: Given SC'}, {'id': 'OG003', 'title': 'Phase IIb Arm 3 (Exploratory Cohort )', 'description': '4 cycles of sirolimus in combination with DEC205mAb-NY-ESO-01 fusion protein (CDX-1401) with adjuvant poly-ICLC'}], 'timeFrame': 'Up to 12 months', 'description': 'Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed.', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 0 patients with this information analyzed. All efforts were made to retrieve data.'}, {'type': 'SECONDARY', 'title': 'Frequency of Memory T Cell Populations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I (CDX-1401, Poly ICLC, and a Fixed Daily Dose of INCB024360 )', 'description': 'Patients will receive a fixed intracutaneous dose of DEC205mAb-NY-ESO-1 fusion protein (CDX-1401) (Day 1) given with subcutaneous adjuvant poly-ICLC (Day 1 and Day 2) for each 28 day cycle for a total of 5 cycles; and Cohort 1 patient enrollment will begin INCB024360 at a fixed daily dose of BID orally'}, {'id': 'OG001', 'title': 'Arm II 2a (CDX-1401, Poly ICLC, Without IDO1 Inhibitor INCB024360)', 'description': 'Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, without IDO1 inhibitor INCB024360 in phase IIb.\n\nDEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection\n\nEpacadostat: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPharmacological Study: Correlative studies\n\nPoly ICLC: Given SC'}, {'id': 'OG002', 'title': 'Arm II 2b (CDX-1401, Poly ICLC, With IDO1 Inhibitor INCB024360)', 'description': 'Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, with IDO1 inhibitor INCB024360 in phase IIb.\n\nDEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection\n\nEpacadostat: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPharmacological Study: Correlative studies\n\nPoly ICLC: Given SC'}, {'id': 'OG003', 'title': 'Phase IIb Arm 3 (Exploratory Cohort )', 'description': '4 cycles of sirolimus in combination with DEC205mAb-NY-ESO-01 fusion protein (CDX-1401) with adjuvant poly-ICLC'}], 'timeFrame': 'Up to 12 months', 'description': 'Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed.', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 0 patients with this information analyzed. All efforts were made to retrieve data.'}, {'type': 'SECONDARY', 'title': 'NY-ESO-1 Specific CD8+ and CD4+ Frequency and Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I (CDX-1401, Poly ICLC, and a Fixed Daily Dose of INCB024360 )', 'description': 'Patients will receive a fixed intracutaneous dose of DEC205mAb-NY-ESO-1 fusion protein (CDX-1401) (Day 1) given with subcutaneous adjuvant poly-ICLC (Day 1 and Day 2) for each 28 day cycle for a total of 5 cycles; and Cohort 1 patient enrollment will begin INCB024360 at a fixed daily dose of BID orally'}, {'id': 'OG001', 'title': 'Arm II 2a (CDX-1401, Poly ICLC, Without IDO1 Inhibitor INCB024360)', 'description': 'Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, without IDO1 inhibitor INCB024360 in phase IIb.\n\nDEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection\n\nEpacadostat: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPharmacological Study: Correlative studies\n\nPoly ICLC: Given SC'}, {'id': 'OG002', 'title': 'Arm II 2b (CDX-1401, Poly ICLC, With IDO1 Inhibitor INCB024360)', 'description': 'Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, with IDO1 inhibitor INCB024360 in phase IIb.\n\nDEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection\n\nEpacadostat: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPharmacological Study: Correlative studies\n\nPoly ICLC: Given SC'}, {'id': 'OG003', 'title': 'Phase IIb Arm 3 (Exploratory Cohort )', 'description': '4 cycles of sirolimus in combination with DEC205mAb-NY-ESO-01 fusion protein (CDX-1401) with adjuvant poly-ICLC'}], 'timeFrame': 'Up to 12 months', 'description': 'Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed.', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 0 patients with this information analyzed. All efforts were made to retrieve data.'}, {'type': 'SECONDARY', 'title': 'T Cell Receptor (TCR) Avidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I (CDX-1401, Poly ICLC, and a Fixed Daily Dose of INCB024360 )', 'description': 'Patients will receive a fixed intracutaneous dose of DEC205mAb-NY-ESO-1 fusion protein (CDX-1401) (Day 1) given with subcutaneous adjuvant poly-ICLC (Day 1 and Day 2) for each 28 day cycle for a total of 5 cycles; and Cohort 1 patient enrollment will begin INCB024360 at a fixed daily dose of BID orally'}, {'id': 'OG001', 'title': 'Arm II 2a (CDX-1401, Poly ICLC, Without IDO1 Inhibitor INCB024360)', 'description': 'Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, without IDO1 inhibitor INCB024360 in phase IIb.\n\nDEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection\n\nEpacadostat: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPharmacological Study: Correlative studies\n\nPoly ICLC: Given SC'}, {'id': 'OG002', 'title': 'Arm II 2b (CDX-1401, Poly ICLC, With IDO1 Inhibitor INCB024360)', 'description': 'Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, with IDO1 inhibitor INCB024360 in phase IIb.\n\nDEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection\n\nEpacadostat: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPharmacological Study: Correlative studies\n\nPoly ICLC: Given SC'}, {'id': 'OG003', 'title': 'Phase IIb Arm 3 (Exploratory Cohort )', 'description': '4 cycles of sirolimus in combination with DEC205mAb-NY-ESO-01 fusion protein (CDX-1401) with adjuvant poly-ICLC'}], 'timeFrame': 'Up to 12 months', 'description': 'Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed.', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 0 patients with this information analyzed. All efforts were made to retrieve data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase I (CDX-1401, Poly ICLC)', 'description': 'DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.\n\nAdjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles\n\n\\+ INCB024360 (Oral) : 300 mg BID for a total of 7 cycles'}, {'id': 'FG001', 'title': 'Phase IIb arm1 (CDX-1401, Poly ICLC, IDO1 Without Inhibitor INCB024360)', 'description': 'DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.\n\nAdjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles'}, {'id': 'FG002', 'title': 'Phase IIb arm2 (CDX-1401, Poly ICLC, With IDO1 Inhibitor INCB024360)', 'description': 'DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.\n\nAdjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles\n\n\\+ INCB024360 (Oral) : 300 mg BID for a total of 7 cycles'}, {'id': 'FG003', 'title': 'Phase IIb Arm 3 (Exploratory Cohort. Enrollment at Roswell Park Site ONLY. )', 'description': 'DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.\n\nAdjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles\n\n\\+ Sirolimus: 4 cycles of 4 mg/day for 2 weeks followed by 2 weeks off'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase I (CDX-1401, Poly ICLC)', 'description': 'DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.\n\nAdjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles\n\n\\+ INCB024360 (Oral) : 300 mg BID for a total of 7 cycles'}, {'id': 'BG001', 'title': 'Phase IIb arm1 (CDX-1401, Poly ICLC, IDO1 Without Inhibitor INCB024360)', 'description': 'DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.\n\nAdjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles'}, {'id': 'BG002', 'title': 'Phase IIb arm2 (CDX-1401, Poly ICLC, With IDO1 Inhibitor INCB024360)', 'description': 'DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.\n\nAdjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles\n\n\\+ INCB024360 (Oral) : 300 mg BID for a total of 7 cycles'}, {'id': 'BG003', 'title': 'Phase IIb Arm 3 (Exploratory Cohort. Enrollment at Roswell Park Site ONLY. )', 'description': 'DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles.\n\nAdjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles\n\n\\+ Sirolimus: 4 cycles of 4 mg/day for 2 weeks followed by 2 weeks off'}, {'id': 'BG004', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '12', 'groupId': 'BG000'}, {'value': '65', 'spread': '10', 'groupId': 'BG001'}, {'value': '63', 'spread': '10', 'groupId': 'BG002'}, {'value': '63', 'spread': '8', 'groupId': 'BG003'}, {'value': '64', 'spread': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'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'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Eligible patients will be women ≥ 18 years, with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma after chemotherapy with no evidence of disease or minimal residual disease for primary or recurrent disease.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-13', 'size': 905882, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-22T13:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-27', 'studyFirstSubmitDate': '2014-04-21', 'resultsFirstSubmitDate': '2022-03-22', 'studyFirstSubmitQcDate': '2014-06-16', 'lastUpdatePostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-27', 'studyFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Determine the Safety and Evaluate Toxicity of Fixed Doses for Phase I Patients', 'timeFrame': '28 days', 'description': 'To determine the safety of fixed doses of DEC205mAb-NY-ESO-1 fusion protein with adjuvant poly-ICLC given as a vaccine in combination with INCB024360 300mg, number of Participants with Dose Limiting Toxicities is reported'}, {'measure': 'Progression Free Survival (PFS) Based on Immune Related Response Criteria (irRC) for Phase II Patients', 'timeFrame': 'Up to 6 months', 'description': 'Percentage of Participants with Progression Free Survival Using irRC Criteria for Phase II Patients are reported. irRC criteria disease progression is defined as at least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 weeks apart.'}, {'measure': 'To Evaluate Toxicity as Defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.', 'timeFrame': 'Up to 12 months', 'description': 'All patients enrolled in this study will be eligible for the analysis of toxicity. The toxicity rate will be estimated using a one-sided, 95%, exact binomial confidence interval (Clopper-Pearson).'}], 'secondaryOutcomes': [{'measure': 'Antibody Titers', 'timeFrame': 'Up to 12 months', 'description': 'Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed.'}, {'measure': 'Frequency of Memory T Cell Populations', 'timeFrame': 'Up to 12 months', 'description': 'Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed.'}, {'measure': 'NY-ESO-1 Specific CD8+ and CD4+ Frequency and Function', 'timeFrame': 'Up to 12 months', 'description': 'Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed.'}, {'measure': 'T Cell Receptor (TCR) Avidity', 'timeFrame': 'Up to 12 months', 'description': 'Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Fallopian Tube Carcinoma', 'Ovarian Carcinoma', 'Primary Peritoneal Carcinoma']}, 'descriptionModule': {'briefSummary': 'This partially randomized phase I/IIb trial studies the side effects and best dose of IDO1 inhibitor INCB024360 in combination with DEC-205/NY-ESO-1 fusion protein CDX-1401 and poly ICLC and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer who no longer have evidence of disease. Antigens (such as cancer/testis antigen \\[NY-ESO-1\\] protein) are found on many cancer cells. Vaccines made from NY-ESO-1 protein may cause the immune system to produce immune cells and antibodies that may help locate the NY-ESO-1 and/or cancer/testis antigen 2 (LAGE-1) antigens on cancer cells. By finding them, the immune system may then work to control or eliminate the remaining cancer cells. INCB024360 is an inhibitor of an enzyme called indoleamine 2,3 dioxygenase (IDO). This enzyme is produced by tumor cells to disable immune cells, and limit the efficacy of immune attack. Giving DEC-205/NY-ESO-1 fusion protein CDX-1401 with poly ICLC and IDO1 inhibitor INCB024360 may generate stronger and more long lasting anti-cancer immune responses in patients with ovarian, fallopian tube, and primary peritoneal cancer in remission.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the safety of fixed doses of DEC205mAb-NY-ESO-1 fusion protein (DEC-205/NY-ESO-1 fusion protein CDX-1401) with adjuvant poly-ICLC given as a vaccine in combination with INCB024360 (IDO1 inhibitor INCB024360). (Phase I) II. To evaluate toxicity as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. (Phase I) III. To determine the progression free survival (PFS) (primary endpoint) using standard immune-related response criteria (irRC) criteria. (Phase IIb)\n\nSECONDARY OBJECTIVES:\n\nI. To determine the effectiveness of INCB024360 on enhancing vaccine efficacy by assessing cancer-testis antigen (NY-ESO-1) specific cellular and humoral immunity.\n\nII. To determine the effectiveness of Sirolimus on enhancing vaccine efficacy by assessing NY-ESO-1 specific cellular and humoral immunity (Exploratory Cohort ONLY) III. Peripheral blood NY-ESO-1 specific cluster of differentiation (CD)8+ and CD4+ T cells. (Exploratory Cohort ONLY) IV. Peripheral blood NY-ESO-1 specific antibodies.(Exploratory Cohort ONLY) V. Peripheral blood frequency of CD4+CD25+forkhead box P3 (FOXP3)+ regulatory T cells. (Exploratory Cohort ONLY) VI. Pharmacokinetics of INCB02360 in relation to T cell frequency and function in correlation with PFS. (Exploratory Cohort ONLY)\n\nOUTLINE:\n\nPHASE I:\n\nPatients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 via intracutaneous injection on day 1, poly ICLC subcutaneously (SC) on days 1 and 2, and IDO1 inhibitor INCB024360 orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients receive IDO1 inhibitor INCB024360 for up to 7 courses.\n\nPHASE IIb: Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 and poly ICLC as in Phase I.\n\nARM II: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, and IDO1 inhibitor INCB024360 as in Phase I.\n\nAfter completion of study treatment, patients are followed up for 30 days and then at 3, 6, and 12 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Eligible patients will be women with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma after chemotherapy with no evidence of disease or minimal residual disease for primary or recurrent disease; this may or may not be measurable; these patients would normally enter a period of observation after standard management\n* Any human leukocyte antigen (HLA) type; (historic HLA typing is permitted)\n* Tumor expression of NY-ESO-1 or LAGE-1 by immunohistochemistry (IHC) and/or reverse transcriptase polymerase chain reaction (RTPCR)\n* Life expectancy \\> 6 months\n* Absolute neutrophil count (ANC) \\>= 1,000/uL\n* Platelets (PLT) \\>= 100,000/uL\n* Hemoglobin (Hgb) \\>= 8 g/dL\n* Total bilirubin =\\< 1.5 x upper limit of normal (ULN)\n* Serum aspartate aminotransferase (serum glutamic oxaloacetic transaminase \\[SGOT\\]/AST) or serum alanine aminotransferase (serum glutamate pyruvate transaminase \\[SGPT\\]/ALT) =\\< 3 x ULN\n* Serum creatinine =\\< 2 x ULN\n* Have been informed of other treatment options\n* Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\\< 2\n* The ability to swallow and retain oral medication\n* Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment\n* Patients may have received previous NY-ESO-1 vaccine therapy; patients who received maintenance paclitaxel or bevacizumab are eligible for enrollment provided they have discontinued therapy (at least 4 weeks for prior taxane or prior bevacizumab) prior to randomization and recovered from toxicities to less than grade 2\n\nExclusion Criteria:\n\n* Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available\n* Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)\n* History of severe autoimmune disorders requiring use of steroids or other immunosuppressives\n* Concomitant systemic treatment with chronic use (based on the investigator's judgment) of corticosteroids, anti-histamine or non-steroidal anti-inflammatory drugs, and other platelet inhibitory agents\n* Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing of study drug (6 weeks for nitrosoureas); concomitant hormonal therapies for breast cancers are allowed\n* Subjects being treated with a monoamine oxidase inhibitor (MAOI), or drug which has significant MAOI activity (e.g., Meperidine, linezolid, methylene blue) within 3 weeks prior to screening\n* Subjects who are currently receiving therapy with a potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer or inhibitor (e.g. clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir)\n* Use of UDP glucuronosyltransferase 1 family, polypeptide A9 (UGT1A9) inhibitor including: diclofenac, imipramine, and ketoconazole\n* Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study drug\n* Known hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)\n* Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study\n* Lack of availability of a patient for immunological and clinical follow-up assessment\n* Evidence of current drug or alcohol abuse or psychiatric impairment, which in the Investigator's opinion will prevent completion of the protocol therapy or follow-up\n* Pregnant or nursing female patients\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug (i.e., any significant medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the patient's risk by participating in this study)\n* Known hypersensitivity to any of the study drugs that will be given to the participant\n* Additional exclusion criteria for exploratory cohort ONLY: Known pulmonary hypertension"}, 'identificationModule': {'nctId': 'NCT02166905', 'briefTitle': 'DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'A Phase I/IIb Study of DEC205mAb-NY-ESO-1 Fusion Protein (CDX-1401) Given With Adjuvant Poly-ICLC in Combination With INCB024360 for Patients in Remission With Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma Whose Tumors Express NY-ESO-1 or LAGE-1 Antigen', 'orgStudyIdInfo': {'id': 'I 248613'}, 'secondaryIdInfos': [{'id': 'NCI-2014-00771', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'I 248613', 'type': 'OTHER', 'domain': 'Roswell Park Cancer Institute'}, {'id': 'P30CA016056', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016056', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (CDX-1401, poly ICLC)', 'description': 'Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 and poly ICLC as in Phase I.', 'interventionNames': ['Biological: DEC-205/NY-ESO-1 Fusion Protein CDX-1401', 'Other: Laboratory Biomarker Analysis', 'Other: Pharmacological Study', 'Drug: Poly ICLC']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (CDX-1401, poly ICLC, IDO1 inhibitor INCB024360)', 'description': 'Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, and IDO1 inhibitor INCB024360 as in Phase I.', 'interventionNames': ['Biological: DEC-205/NY-ESO-1 Fusion Protein CDX-1401', 'Drug: Epacadostat', 'Other: Laboratory Biomarker Analysis', 'Other: Pharmacological Study', 'Drug: Poly ICLC']}], 'interventions': [{'name': 'DEC-205/NY-ESO-1 Fusion Protein CDX-1401', 'type': 'BIOLOGICAL', 'otherNames': ['CDX-1401'], 'description': 'Given via intracutaneous injection', 'armGroupLabels': ['Arm I (CDX-1401, poly ICLC)', 'Arm II (CDX-1401, poly ICLC, IDO1 inhibitor INCB024360)']}, {'name': 'Epacadostat', 'type': 'DRUG', 'otherNames': ['INCB 024360', 'INCB024360'], 'description': 'Given PO', 'armGroupLabels': ['Arm II (CDX-1401, poly ICLC, IDO1 inhibitor INCB024360)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (CDX-1401, poly ICLC)', 'Arm II (CDX-1401, poly ICLC, IDO1 inhibitor INCB024360)']}, {'name': 'Pharmacological Study', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (CDX-1401, poly ICLC)', 'Arm II (CDX-1401, poly ICLC, IDO1 inhibitor INCB024360)']}, {'name': 'Poly ICLC', 'type': 'DRUG', 'otherNames': ['Hiltonol', 'Poly I:Poly C with Poly-L-Lysine Stabilizer', 'poly-ICLC', 'PolyI:PolyC with Poly-L-Lysine Stabilizer', 'Polyinosinic-Polycytidylic Acid Stabilized with Polylysine and Carboxymethylcellulose', 'Polyriboinosinic-Polyribocytidylic Acid-Polylysine Carboxymethylcellulose', 'Stabilized Polyriboinosinic/Polyribocytidylic Acid'], 'description': 'Given SC', 'armGroupLabels': ['Arm I (CDX-1401, poly ICLC)', 'Arm II (CDX-1401, poly ICLC, IDO1 inhibitor INCB024360)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Emese Zsiros, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Celldex Therapeutics', 'class': 'INDUSTRY'}, {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}