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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:

Active, not recruiting

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 Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the investigator
Time Frame:From enrollment until disease progression (up to approximately 2 years)
Safety Issue:
Description:Cohort A1only

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:Cohort A1 only
Measure:Progression-free survival (PFS)
Time Frame:From randomization until disease progression (up to approximately 2 years)
Safety Issue:
Description:Cohorts A1 only
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:Cohorts A1 only
Measure:Safety and tolerability of rucaparib in combination with nivolumab: incidence of adverse events, clinical laboratory abnormalities and clinical dose modifications
Time Frame:From randomization until disease progression (up to approximately 2 years)
Safety Issue:
Description:The evaluation of the incidence of adverse events, clinical laboratory abnormalities and clinical dose modifications; All Cohorts

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
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

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