A Phase 2, Open-label Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
Overview
- Phase
- Phase 2
- Intervention
- Rucaparib
- Conditions
- Epithelial Ovarian Cancer
- Sponsor
- pharmaand GmbH
- Enrollment
- 1
- Locations
- 5
- Primary Endpoint
- Objective Response Rate (ORR) by RECIST v1.1 as Assessed by the Investigator
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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 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
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort A: Ovarian Cancer Cohort
Oral rucaparib and Intravenous (IV) nivolumab (combination therapy) * Cohort A1 * Cohort A2
Intervention: Rucaparib
Cohort A: Ovarian Cancer Cohort
Oral rucaparib and Intravenous (IV) nivolumab (combination therapy) * Cohort A1 * Cohort A2
Intervention: Nivolumab
Outcomes
Primary Outcomes
Objective Response Rate (ORR) by RECIST v1.1 as Assessed by the Investigator
Time Frame: From enrollment until disease progression (up to approximately 2 years)
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.
The Effect of Rucaparib on the Immune Microenvironment
Time Frame: From enrollment to primary completion of study (up to approximately 2 years)
Change in expression of the immune marker PD-L1 pre and post-rucaparib treatment; Cohort A2 only
Secondary Outcomes
- ORR by RECIST v1.1 and Gynecological Cancer InterGroup (GCIG) Cancer Antigen 125 (CA-125 Criteria)(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.)
- Progression-free Survival (PFS)(From randomization until disease progression (up to approximately 2 years))
- Duration of Response (DOR)(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)