Ovarian Cancer Clinical Trial
A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
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 following cohorts must have BRCA mutational status confirmed by a central lab:
Cohort A1: No BRCA mutation in tumor; high level of LOH (loss of heterozygosity)
Cohort A2: BRCA mutation in tumor
Eligibility Criteria
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.
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There are 5 Locations for this study
Clovis California, 93611, United States
Savannah Georgia, 31404, United States
Covington Louisiana, 70433, United States
Oklahoma City Oklahoma, 73104, United States
Burlington Vermont, 05041, United States
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