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

Sponsor: pharmaand GmbH

Sponsor score: 0

ClinicalTrials ID:NCT03522246

This Phase 3 study assesses rucaparib and nivolumab as maintenance therapy in advanced ovarian cancer post-platinum chemotherapy. Eligible patients have completed surgery and chemotherapy with a response, possess sufficient tumor tissue, and have an ECOG status of 0 or 1. Interventions include oral rucaparib, IV nivolumab, and corresponding placebos.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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

Locations

FACILITYZIPCITYSTATE
Arizona Oncology Associates, PC - HAL85016PhoenixArizona
Arizona Oncology Associates, PC - HOPE85711TucsonArizona
The University of Arizona Cancer Center85724TucsonArizona
John Muir Clinical Research Center94520ConcordCalifornia
UCLA Women's Health Clinical Research Unit90095Los AngelesCalifornia
Kaiser Permanente Northern California94589San FranciscoCalifornia
University of Colorado Cancer Center80045AuroraColorado
Rocky Mountain Cancer Centers80228LakewoodColorado
Yale University06520New HavenConnecticut
Florida Gynecologic Oncology33905Fort MyersFlorida

Get This Program In Your Inbox

You can sign up and apply your patients for this program.