Description:
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
Title
- Brief Title: A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
- Official Title: A Phase 2, Open-label Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
Clinical Trial IDs
- ORG STUDY ID:
CO-338-097
- NCT ID:
NCT03824704
Conditions
- Epithelial Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Carcinoma
- High Grade Serous Carcinoma
- Endometrioid Adenocarcinoma
Interventions
Drug | Synonyms | Arms |
---|
Rucaparib | Rubraca, CO-338 | Cohort A: Ovarian Cancer Cohort |
Nivolumab | Opdivo, BMS-936558 | Cohort A: Ovarian Cancer Cohort |
Purpose
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
Trial Arms
Name | Type | Description | Interventions |
---|
Cohort A: Ovarian Cancer Cohort | Experimental | Oral rucaparib and Intravenous (IV) nivolumab (combination therapy)
Cohort A1
Cohort A2 | |
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 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) |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | ORR by RECIST v1.1 and Gynecological Cancer InterGroup (GCIG) Cancer Antigen 125 (CA-125 Criteria) |
Time Frame: | 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. |
Safety Issue: | |
Description: | 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 RECIST v1.1 as assessed by the investigator or a confirmed response per Gynecological Cancer InterGroup (GCIG) cancer antigen 125 (CA-125 criteria) |
Measure: | Progression-free Survival (PFS) |
Time Frame: | From randomization until disease progression (up to approximately 2 years) |
Safety Issue: | |
Description: | Progression-Free Survival (PFS) is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first. |
Measure: | Duration of Response (DOR) |
Time Frame: | 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 |
Safety Issue: | |
Description: | Duration of response (DOR) for any confirmed RECIST CR or PR measured from the date of the first response until the first date that progressive disease (PD) is documented. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Clovis Oncology, Inc. |
Trial Keywords
- PARP
- PARPi
- PARP inhibitor
- ARIES
- Opdivo
- Rucaparib
- Nivolumab
- PD-1
- BRCA
- LOH
- CO-338
- Immunotherapy
- BMS-936558
- Clovis
- Clovis Oncology
- Rubraca
Last Updated
June 15, 2021