Trials / Terminated
TerminatedNCT03824704
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)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- pharmaand GmbH · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rucaparib | Oral rucaparib will be administered twice daily |
| DRUG | Nivolumab | IV nivolumab will be administered once every 4 weeks |
Timeline
- Start date
- 2019-08-23
- Primary completion
- 2020-08-24
- Completion
- 2020-08-24
- First posted
- 2019-01-31
- Last updated
- 2023-06-12
- Results posted
- 2021-06-15
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03824704. Inclusion in this directory is not an endorsement.