Status:
TERMINATED
A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
Lead Sponsor:
pharmaand GmbH
Collaborating Sponsors:
Bristol-Myers Squibb
Foundation Medicine
Conditions:
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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. Patients entering the foll...
Eligibility Criteria
Inclusion
- General Inclusion Criteria:
- ≥ 18 years of age
- Adequate organ function
- Life expectancy ≥ 16 weeks
- Women of childbearing potential must have a negative serum pregnancy test
- High-grade serous or endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Received 1 or 2 prior regimens, including ≥ 1 prior platinum-based therapy and have platinum-sensitive disease
- Relapsed/progressive disease (confirmed by radiologic assessment)
- Willing and able to have a biopsy of tumor at screening and after 4 weeks of treatment.
- Measurable disease (RECIST v1.1)- Cohort A1 only
- ECOG performance status of 0 to 1
- General Exclusion Criteria
- Active second malignancy
- Central nervous system brain metastases
- Evidence of interstitial lung disease, active pneumonitis, myocarditis, or history of myocarditis.
- Active, known or suspected autoimmune disease (eg, autoimmune hepatitis).
- Condition requiring systemic treatment with either corticosteroids
- Prior treatment with a PARP inhibitor or immune checkpoint inhibitor.
- Non-epithelial tumors (pure sarcomas) or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors. Mixed Mullerian tumors/carcinosarcomas are allowed.
Exclusion
Key Trial Info
Start Date :
August 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03824704
Start Date
August 23 2019
End Date
August 24 2020
Last Update
June 12 2023
Active Locations (5)
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1
Community Cancer Institute
Clovis, California, United States, 93611
2
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
3
Women's Cancer Care
Covington, Louisiana, United States, 70433
4
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104