Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-02-03 @ 3:55 AM
Study NCT ID:
NCT03824704
Status:
TERMINATED
Last Update Posted:
2023-06-12
First Post:
2019-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
Sponsor:
Organization:
Raw JSON
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Sponsor may request deletion of confidential information or a delay in publication to address intellectual property concerns, but Sponsor may not suppress publication of the trial results indefinitely. Sponsor may request delay of a single-center publication until after the release of a multi-site publication or an agreed upon period of time.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The Sponsor made a business decision to discontinue the study due to low accrual.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.', 'description': 'If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort A: Ovarian Cancer Cohort', 'description': 'Patients received combination therapy, including oral rucaparib 600mg administered twice daily starting on Cycle 1 Day 1 and intravenous (IV) nivolumab 480mg administered on Day 1 of every 4-week 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'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dsypepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hair texture abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR) by RECIST v1.1 as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Ovarian Cancer Cohort', 'description': 'Patients received combination therapy, including oral rucaparib 600mg administered twice daily starting on Cycle 1 Day 1 and intravenous (IV) nivolumab 480mg administered on Day 1 of every 4-week cycle, starting on Cycle 2 Day 1.'}], 'timeFrame': 'From enrollment until disease progression (up to approximately 2 years)', 'description': 'Objective response rate (ORR) is defined as the percentage of patients with a best confirmed response of complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the investigator.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was discontinued by the sponsor so no data is available for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'The Effect of Rucaparib on the Immune Microenvironment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Ovarian Cancer Cohort', 'description': 'Patients received combination therapy, including oral rucaparib 600mg administered twice daily starting on Cycle 1 Day 1 and intravenous (IV) nivolumab 480mg administered on Day 1 of every 4-week cycle, starting on Cycle 2 Day 1.'}], 'timeFrame': 'From enrollment to primary completion of study (up to approximately 2 years)', 'description': 'Change in expression of the immune marker PD-L1 pre and post-rucaparib treatment; Cohort A2 only', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was discontinued by the sponsor so no data is available for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'ORR by RECIST v1.1 and Gynecological Cancer InterGroup (GCIG) Cancer Antigen 125 (CA-125 Criteria)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Ovarian Cancer Cohort', 'description': 'Patients received combination therapy, including oral rucaparib 600mg administered twice daily starting on Cycle 1 Day 1 and intravenous (IV) nivolumab 480mg administered on Day 1 of every 4-week cycle, starting on Cycle 2 Day 1.'}], 'timeFrame': 'For patients with measurable disease, every 8 weeks after the start of combination treatment for 3 years, then every 24 weeks thereafter until disease progression or up to 25 months. Study data collection expected to last for 2 years.', 'description': 'Objective Response Rate (ORR) is defined as the percentage of patients with a best confirmed response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by the investigator or a confirmed response per Gynecological Cancer InterGroup (GCIG) cancer antigen 125 (CA-125 criteria)', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was discontinued by the sponsor so no data is available for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Ovarian Cancer Cohort', 'description': 'Patients received combination therapy, including oral rucaparib 600mg administered twice daily starting on Cycle 1 Day 1 and intravenous (IV) nivolumab 480mg administered on Day 1 of every 4-week cycle, starting on Cycle 2 Day 1.'}], 'timeFrame': 'From randomization until disease progression (up to approximately 2 years)', 'description': 'Progression-Free Survival (PFS) is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was discontinued by the sponsor so no data is available for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Ovarian Cancer Cohort', 'description': 'Patients received combination therapy, including oral rucaparib 600mg administered twice daily starting on Cycle 1 Day 1 and intravenous (IV) nivolumab 480mg administered on Day 1 of every 4-week cycle, starting on Cycle 2 Day 1.'}], 'timeFrame': 'For patients with measurable disease, every 12 weeks after the start of combination treatment for 3 years, then every 24 weeks thereafter until disease progression. Study data collection expected to last for 2 years', 'description': 'Duration of response (DOR) for any confirmed RECIST CR or PR measured from the date of the first response until the first date that progressive disease (PD) is documented.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was discontinued by the sponsor so no data is available for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort A: Ovarian Cancer Cohort', 'description': 'Patients received combination therapy, including oral rucaparib 600mg administered twice daily starting on Cycle 1 Day 1 and intravenous (IV) nivolumab 480mg administered on Day 1 of every 4-week cycle, starting on Cycle 2 Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '1 subject was recruited from 1 site in the United States. The Sponsor then discontinued the study due to low accrual.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A: Ovarian Cancer Cohort', 'description': 'Patients received combination therapy, including oral rucaparib 600mg administered twice daily starting on Cycle 1 Day 1 and intravenous (IV) nivolumab 480mg administered on Day 1 of every 4-week cycle, starting on Cycle 2 Day 1.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-30', 'size': 2956839, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-19T02:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Sponsor made a business decision to discontinue the study due to low accrual.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-08-23', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-07', 'studyFirstSubmitDate': '2019-01-21', 'resultsFirstSubmitDate': '2021-05-19', 'studyFirstSubmitQcDate': '2019-01-30', 'lastUpdatePostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-19', 'studyFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) by RECIST v1.1 as Assessed by the Investigator', 'timeFrame': 'From enrollment until disease progression (up to approximately 2 years)', 'description': 'Objective response rate (ORR) is defined as the percentage of patients with a best confirmed response of complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the investigator.'}, {'measure': 'The Effect of Rucaparib on the Immune Microenvironment', 'timeFrame': 'From enrollment to primary completion of study (up to approximately 2 years)', 'description': 'Change in expression of the immune marker PD-L1 pre and post-rucaparib treatment; Cohort A2 only'}], 'secondaryOutcomes': [{'measure': 'ORR by RECIST v1.1 and Gynecological Cancer InterGroup (GCIG) Cancer Antigen 125 (CA-125 Criteria)', 'timeFrame': 'For patients with measurable disease, every 8 weeks after the start of combination treatment for 3 years, then every 24 weeks thereafter until disease progression or up to 25 months. Study data collection expected to last for 2 years.', 'description': 'Objective Response Rate (ORR) is defined as the percentage of patients with a best confirmed response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by the investigator or a confirmed response per Gynecological Cancer InterGroup (GCIG) cancer antigen 125 (CA-125 criteria)'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'From randomization until disease progression (up to approximately 2 years)', 'description': 'Progression-Free Survival (PFS) is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'For patients with measurable disease, every 12 weeks after the start of combination treatment for 3 years, then every 24 weeks thereafter until disease progression. Study data collection expected to last for 2 years', 'description': 'Duration of response (DOR) for any confirmed RECIST CR or PR measured from the date of the first response until the first date that progressive disease (PD) is documented.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PARP', 'PARPi', 'PARP inhibitor', 'ARIES', 'Opdivo', 'Rucaparib', 'Nivolumab', 'PD-1', 'BRCA', 'LOH', 'CO-338', 'Immunotherapy', 'BMS-936558', 'Clovis', 'Clovis Oncology', 'Rubraca'], 'conditions': ['Epithelial Ovarian Cancer', 'Fallopian Tube Cancer', 'Primary Peritoneal Carcinoma', 'High Grade Serous Carcinoma', 'Endometrioid Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'This is an open label Phase 2, 2-stage, 2-cohort study to evaluate rucaparib in combination with nivolumab in patients with high-grade serous or endometroid ovarian cancer.\n\nPatients entering the following cohorts must have BRCA mutational status confirmed by a central lab:\n\n* Cohort A1: No BRCA mutation in tumor; high level of LOH (loss of heterozygosity)\n* Cohort A2: BRCA mutation in tumor'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'General Inclusion Criteria:\n\n* ≥ 18 years of age\n* Adequate organ function\n* Life expectancy ≥ 16 weeks\n* Women of childbearing potential must have a negative serum pregnancy test\n* High-grade serous or endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer\n* Received 1 or 2 prior regimens, including ≥ 1 prior platinum-based therapy and have platinum-sensitive disease\n* Relapsed/progressive disease (confirmed by radiologic assessment)\n* Willing and able to have a biopsy of tumor at screening and after 4 weeks of treatment.\n* Measurable disease (RECIST v1.1)- Cohort A1 only\n* ECOG performance status of 0 to 1\n\nGeneral Exclusion Criteria\n\n* Active second malignancy\n* Central nervous system brain metastases\n* Evidence of interstitial lung disease, active pneumonitis, myocarditis, or history of myocarditis.\n* Active, known or suspected autoimmune disease (eg, autoimmune hepatitis).\n* Condition requiring systemic treatment with either corticosteroids\n* Prior treatment with a PARP inhibitor or immune checkpoint inhibitor.\n* Non-epithelial tumors (pure sarcomas) or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors. Mixed Mullerian tumors/carcinosarcomas are allowed.'}, 'identificationModule': {'nctId': 'NCT03824704', 'briefTitle': 'A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)', 'organization': {'class': 'INDUSTRY', 'fullName': 'pharmaand GmbH'}, 'officialTitle': 'A Phase 2, Open-label Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)', 'orgStudyIdInfo': {'id': 'CO-338-097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A: Ovarian Cancer Cohort', 'description': 'Oral rucaparib and Intravenous (IV) nivolumab (combination therapy)\n\n* Cohort A1\n* Cohort A2', 'interventionNames': ['Drug: Rucaparib', 'Drug: Nivolumab']}], 'interventions': [{'name': 'Rucaparib', 'type': 'DRUG', 'otherNames': ['Rubraca', 'CO-338'], 'description': 'Oral rucaparib will be administered twice daily', 'armGroupLabels': ['Cohort A: Ovarian Cancer Cohort']}, {'name': 'Nivolumab', 'type': 'DRUG', 'otherNames': ['Opdivo', 'BMS-936558'], 'description': 'IV nivolumab will be administered once every 4 weeks', 'armGroupLabels': ['Cohort A: Ovarian Cancer Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93611', 'city': 'Clovis', 'state': 'California', 'country': 'United States', 'facility': 'Community Cancer Institute', 'geoPoint': {'lat': 36.82523, 'lon': -119.70292}}, {'zip': '31404', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Memorial Health University Medical Center', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'country': 'United States', 'facility': "Women's Cancer Care", 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Stephenson Cancer Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '05041', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont Medical Center', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Kathleen N Moore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lead Investigator for Ovarian Cohort A'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'pharmaand GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, {'name': 'Foundation Medicine', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}