Clinical Trials /

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

NCT03824704

Description:

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

Related Conditions:
  • Fallopian Tube Endometrioid Adenocarcinoma
  • High Grade Fallopian Tube Serous Adenocarcinoma
  • Malignant Ovarian Epithelial Tumor
  • Malignant Ovarian Serous Tumor
  • Primary Peritoneal Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
  • Official Title: A Phase 2, Open-label Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)

Clinical Trial IDs

  • ORG STUDY ID: CO-338-097
  • NCT ID: NCT03824704

Conditions

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

Interventions

DrugSynonymsArms
RucaparibRubraca, CO-338Cohort A: Ovarian Cancer Cohort
NivolumabOpdivo, BMS-936558Cohort A: Ovarian Cancer Cohort

Purpose

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 Arms

NameTypeDescriptionInterventions
Cohort A: Ovarian Cancer CohortExperimentalOral rucaparib and Intravenous (IV) nivolumab (combination therapy) Cohort A1 Cohort A2
  • Rucaparib
  • Nivolumab

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

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)
Safety Issue:
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.

Secondary Outcome Measures

Measure:ORR by RECIST v1.1 and Gynecological Cancer InterGroup (GCIG) Cancer Antigen 125 (CA-125 Criteria)
Time Frame: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.
Safety Issue:
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 RECIST v1.1 as assessed by the investigator or a confirmed response per Gynecological Cancer InterGroup (GCIG) cancer antigen 125 (CA-125 criteria)
Measure:Progression-free Survival (PFS)
Time Frame:From randomization until disease progression (up to approximately 2 years)
Safety Issue:
Description:Progression-Free Survival (PFS) is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first.
Measure:Duration of Response (DOR)
Time Frame: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
Safety Issue:
Description:Duration of response (DOR) for any confirmed RECIST CR or PR measured from the date of the first response until the first date that progressive disease (PD) is documented.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Clovis Oncology, Inc.

Trial Keywords

  • PARP
  • PARPi
  • PARP inhibitor
  • ARIES
  • Opdivo
  • Rucaparib
  • Nivolumab
  • PD-1
  • BRCA
  • LOH
  • CO-338
  • Immunotherapy
  • BMS-936558
  • Clovis
  • Clovis Oncology
  • Rubraca

Last Updated

June 15, 2021