A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)

A Phase 2, Open-label Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)

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

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.