Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor made a business decision to discontinue the study due to low accrual.
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrioid Adenocarcinoma | Endometrioid Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| High Grade Serous Carcinoma | — | UNRESOLVED | — |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cohort A: Ovarian Cancer Cohort
- description
- Oral rucaparib and Intravenous (IV) nivolumab (combination therapy) * Cohort A1 * Cohort A2
- interventionNames
- Drug: Rucaparib
- Drug: Nivolumab
Primary outcomes (2)
- measure
- Objective Response Rate (ORR) by RECIST v1.1 as Assessed by the Investigator
- timeFrame
- From enrollment until disease progression (up to approximately 2 years)
- 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.
- measure
- The Effect of Rucaparib on the Immune Microenvironment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available