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

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ClinicalTrials.gov Identifier: NCT03824704
Recruitment Status : Terminated (Sponsor made a business decision to discontinue the study due to low accrual.)
First Posted : January 31, 2019
Last Update Posted : December 19, 2020
Sponsor:
Collaborators:
Bristol-Myers Squibb
Foundation Medicine
Information provided by (Responsible Party):
Clovis Oncology, Inc.

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma High Grade Serous Carcinoma Endometrioid Adenocarcinoma Drug: Rucaparib Drug: Nivolumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
Actual Study Start Date : May 15, 2019
Actual Primary Completion Date : August 24, 2020
Actual Study Completion Date : August 24, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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:
  • Opdivo
  • BMS-936558


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    Cohort A1only

  2. To study the effect of rucaparib on the immune microenvironment [ Time Frame: From enrollment to primary study 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


Secondary Outcome Measures :
  1. 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 ]
    Cohort A1 only

  2. Progression-free survival (PFS) [ Time Frame: From randomization until disease progression (up to approximately 2 years) ]
    Cohorts A1 only

  3. 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 ]
    Cohorts A1 only

  4. 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) ]
    The evaluation of the incidence of adverse events, clinical laboratory abnormalities and clinical dose modifications; All Cohorts


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824704


Locations
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United States, California
Community Cancer Institute
Clovis, California, United States, 93611
United States, Georgia
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
United States, Louisiana
Women's Cancer Care
Covington, Louisiana, United States, 70433
United States, Oklahoma
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
United States, Vermont
University of Vermont Medical Center
Burlington, Vermont, United States, 05041
Sponsors and Collaborators
Clovis Oncology, Inc.
Bristol-Myers Squibb
Foundation Medicine
Investigators
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Principal Investigator: Kathleen N Moore, MD Lead Investigator for Ovarian Cohort A
More Information
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Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT03824704    
Other Study ID Numbers: CO-338-097
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clovis Oncology, Inc.:
PARP
PARPi
PARP inhibitor
ARIES
Opdivo
Rucaparib
Nivolumab
PD-1
 BRCA
LOH
CO-338
Immunotherapy
BMS-936558
Clovis
Clovis Oncology
Rubraca
Additional relevant MeSH terms:
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Carcinoma
Fallopian Tube Neoplasms
Carcinoma, Ovarian Epithelial
Carcinoma, Endometrioid
Cystadenocarcinoma, Serous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
 Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Endometrial Neoplasms
Uterine Neoplasms
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Nivolumab
Rucaparib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action