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

Part of paid clinical trials in Clovis, California.

Sponsor
pharmaand GmbH
Study ID
NCT03824704
Phase
PHASE2
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rucaparib — DRUG
    Oral rucaparib will be administered twice daily
  • Nivolumab — DRUG
    IV nivolumab will be administered once every 4 weeks

Study Details

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

Key Dates

Start date
Aug 23, 2019
Status verified
Jun 2023
Primary completion
Aug 24, 2020
Completion
Aug 24, 2020

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Ovarian Cancer Cohort
    Oral rucaparib and Intravenous (IV) nivolumab (combination therapy) * Cohort A1 * Cohort A2

Primary Outcome 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) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Community Cancer InstituteClovisCalifornia93611-
Memorial Health University Medical CenterSavannahGeorgia31404-
Women's Cancer CareCovingtonLouisiana70433-
Stephenson Cancer CenterOklahoma CityOklahoma73104-
University of Vermont Medical CenterBurlingtonVermont05041-

Find similar trials in Clovis, CA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Community Cancer Institute· Clovis, CAMemorial Health University Medical Center· Savannah, GAWomen's Cancer Care· Covington, LAStephenson Cancer Center· Oklahoma City, OKUniversity of Vermont Medical Center· Burlington, VT

Related Studies