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

NCT ID: NCT03824704

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-23
• Study Completion Date: 2020-08-24

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

Conditions

Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; High Grade Serous Carcinoma; Endometrioid Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A: Ovarian Cancer Cohort

Oral rucaparib and Intravenous (IV) nivolumab (combination therapy)

• Cohort A1
• Cohort A2

Group Type: EXPERIMENTAL

Rucaparib

Intervention Type: DRUG

Oral rucaparib will be administered twice daily

Nivolumab

Intervention Type: DRUG

IV nivolumab will be administered once every 4 weeks

Interventions

Rucaparib

Oral rucaparib will be administered twice daily

Intervention Type: DRUG

Nivolumab

IV nivolumab will be administered once every 4 weeks

Intervention Type: DRUG

Other Intervention Names

Rubraca; CO-338; Opdivo; BMS-936558

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Foundation Medicine

INDUSTRY

Sponsor Role: collaborator

pharmaand GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen N Moore, MD

Role: PRINCIPAL_INVESTIGATOR

Lead Investigator for Ovarian Cohort A

Locations

Community Cancer Institute

Clovis, California, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Women's Cancer Care

Covington, Louisiana, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

University of Vermont Medical Center

Burlington, Vermont, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CO-338-097

Identifier Type: -

Identifier Source: org_study_id