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

June 7, 2023 updated by: zr Pharma & GmbH

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Clovis, California, United States, 93611
        • Community Cancer Institute
    • Georgia
      • Savannah, Georgia, United States, 31404
        • Memorial Health University Medical Center
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Women'S Cancer Care
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Stephenson Cancer Center
    • Vermont
      • Burlington, Vermont, United States, 05041
        • University of Vermont Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A: Ovarian Cancer Cohort

Oral rucaparib and Intravenous (IV) nivolumab (combination therapy)

  • Cohort A1
  • Cohort A2
Drug: Rucaparib
Oral rucaparib will be administered twice daily
Other Names:
  • Rubraca
  • CO-338
Drug: Nivolumab
IV nivolumab will be administered once every 4 weeks
Other Names:
  • BMS-936558
  • Opdivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
From enrollment until disease progression (up to approximately 2 years)
The Effect of Rucaparib on the Immune Microenvironment
Time Frame: From enrollment to primary completion of study (up to approximately 2 years)
Change in expression of the immune marker PD-L1 pre and post-rucaparib treatment; Cohort A2 only
From enrollment to primary completion of study (up to approximately 2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
Progression-free Survival (PFS)
Time Frame: From randomization until disease progression (up to approximately 2 years)
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.
From randomization until disease progression (up to approximately 2 years)
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

zr Pharma & GmbH

Collaborators

Bristol-Myers Squibb
Foundation Medicine

Investigators

  • Principal Investigator: Kathleen N Moore, MD, Lead Investigator for Ovarian Cohort A

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2019

Primary Completion (Actual)

August 24, 2020

Study Completion (Actual)

August 24, 2020

Study Registration Dates

First Submitted

January 21, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO-338-097

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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