Study Stopped
Sponsor made a business decision to discontinue the study due to low accrual.
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)
1 other identifier
interventional
1
1 country
5
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2019
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2019
CompletedFirst Posted
Study publicly available on registry
January 31, 2019
CompletedStudy Start
First participant enrolled
August 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2020
CompletedResults Posted
Study results publicly available
June 15, 2021
CompletedJune 12, 2023
June 1, 2023
1 year
January 21, 2019
May 19, 2021
June 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Objective Response Rate (ORR) by RECIST v1.1 as Assessed by the Investigator
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.
From enrollment until disease progression (up to approximately 2 years)
The Effect of Rucaparib on the Immune Microenvironment
Change in expression of the immune marker PD-L1 pre and post-rucaparib treatment; Cohort A2 only
From enrollment to primary completion of study (up to approximately 2 years)
Secondary Outcomes (3)
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
Study Arms (1)
Cohort A: Ovarian Cancer Cohort
EXPERIMENTALOral rucaparib and Intravenous (IV) nivolumab (combination therapy) * Cohort A1 * Cohort A2
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- pharmaand GmbHlead
- Bristol-Myers Squibbcollaborator
- Foundation Medicinecollaborator
Study Sites (5)
Community Cancer Institute
Clovis, California, 93611, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Women's Cancer Care
Covington, Louisiana, 70433, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
University of Vermont Medical Center
Burlington, Vermont, 05041, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The Sponsor made a business decision to discontinue the study due to low accrual.
Results Point of Contact
- Title
- Medical Information Department
- Organization
- Clovis Oncology, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen N Moore, MD
Lead Investigator for Ovarian Cohort A
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2019
First Posted
January 31, 2019
Study Start
August 23, 2019
Primary Completion
August 24, 2020
Study Completion
August 24, 2020
Last Updated
June 12, 2023
Results First Posted
June 15, 2021
Record last verified: 2023-06