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

• Status: Terminated
• Trial end date: 2020-08-24
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clovis Oncology, Inc.
• Collaborators: Bristol-Myers Squibb; Foundation Medicine
• Treatments: Antibodies, Monoclonal; Nivolumab; Rucaparib

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.