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

NCT03522246 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1097

Last updated 2025-06-24

Study results available
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Summary

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

Interventions

DRUG

Rucaparib

Oral rucaparib will be administered twice daily

DRUG

Nivolumab

IV nivolumab will be administered once every 4 weeks

DRUG

Placebo Oral Tablet

Placebo tablets will be administered twice daily

DRUG

Placebo IV Infusion

IV placebo will be administered once every 4 weeks

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Gynecologic Oncology Group

    collaborator NETWORK

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    collaborator OTHER

  • Foundation Medicine

    collaborator INDUSTRY

  • pharmaand GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-14
Primary Completion
2024-05-20
Completion
2030-12-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Greece
  • Ireland
  • Israel
  • Italy
  • Japan
  • New Zealand
  • Poland
  • Romania
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03522246 on ClinicalTrials.gov