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Purpose

This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or following neoadjuvant chemotherapy (interval debulking)
  • Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator
  • Sufficient tumor tissue for planned analysis
  • ECOG performance status of 0 or 1

Exclusion Criteria

  • Pure sarcomas or borderline tumors or mucinous tumors
  • Active second malignancy
  • Known central nervous system brain metastases
  • Any prior treatment for ovarian cancer, other than the first-line platinum regimen
  • Evidence of interstitial lung disease or active pneumonitis
  • Active, known or suspected autoimmune disease
  • Condition requiring active systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-Blind

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A
oral rucaparib + intravenous (IV) nivolumab
  • 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
Experimental
Arm B
oral rucaparib+IV placebo
  • Drug: Rucaparib
    Oral rucaparib will be administered twice daily
    Other names:
    • Rubraca
    • CO-338
  • Drug: Placebo IV Infusion
    IV placebo will be administered once every 4 weeks
Experimental
Arm C
oral placebo+ IV nivolumab
  • Drug: Nivolumab
    IV nivolumab will be administered once every 4 weeks
    Other names:
    • Opdivo
    • BMS-936558
  • Drug: Placebo Oral Tablet
    Placebo tablets will be administered twice daily
Placebo Comparator
Arm D
Oral placebo + IV placebo
  • Drug: Placebo Oral Tablet
    Placebo tablets will be administered twice daily
  • Drug: Placebo IV Infusion
    IV placebo will be administered once every 4 weeks

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536

More Details

NCT ID
NCT03522246
Status
Recruiting
Sponsor
Clovis Oncology, Inc.

Study Contact

Clovis Oncology Clinical Trial Information
1-855-262-3040 (USA)
clovistrials@emergingmed.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.