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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 : Recruiting
First Posted : January 31, 2019
Last Update Posted : August 2, 2019
Sponsor:
Collaborators:
Bristol-Myers Squibb
Foundation Medicine
Information provided by (Responsible Party):
Clovis Oncology, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 139 participants
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
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022


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




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



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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.

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


Contacts
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Contact: Clovis Oncology Clinical Trial Information 1-855-262-3040 (USA) clovistrials@emergingmed.com
Contact: Clovis Oncology Clinical Trial Information +1-303-625-5160 (ex-US) clovistrials@emergingmed.com

Locations
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United States, California
Community Cancer Institute Recruiting
Clovis, California, United States, 93611
Contact: EmergingMed         
United States, Georgia
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: EmergingMed         
United States, Louisiana
Women's Cancer Care Recruiting
Covington, Louisiana, United States, 70433
Contact: EmergingMed         
United States, Oklahoma
Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: EmergingMed         
United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05041
Contact: EmergingMed         
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

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Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT03824704     History of Changes
Other Study ID Numbers: CO-338-097
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019

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

Additional relevant MeSH terms:
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Rucaparib
Carcinoma
Adenocarcinoma
Fallopian Tube Neoplasms
Carcinoma, Ovarian Epithelial
Carcinoma, Endometrioid
Cystadenocarcinoma, Serous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Ovarian Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders
Endometrial Neoplasms
Uterine Neoplasms
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors