A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

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

  • Epithelial Ovarian Cancer
  • Primary Peritoneal
  • Fallopian Tube Cancer
  • Newly Diagnosed
  • FIGO Stage III-IV
  • Partial Response
  • Complete Response

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 - Patients must be 20 years of age to consent in Japan, Taiwan and South Korea; in all other participating countries patients must be 18 years of age to consent

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

More Details

NCT ID
NCT03522246
Status
Active, not recruiting
Sponsor
pharmaand GmbH