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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Epithelial Ovarian Cancer, Primary Peritoneal, Fallopian Tube Cancer, Newly Diagnosed, FIGO Stage III-IV, Partial Response, Complete Response

In brief

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.

Key facts

Study ID

NCT03522246

Run by

pharmaand GmbH

People needed

1097

Starts

2018-05-14

Expected to finish

2030-12-30

Last updated by the study team

2025-06-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
• The University of Arizona Cancer Center — Tucson, Arizona, United States
• John Muir Clinical Research Center — Concord, California, United States
• UCLA Women's Health Clinical Research Unit — Los Angeles, California, United States
• Kaiser Permanente Northern California — San Francisco, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Rocky Mountain Cancer Centers — Lakewood, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Florida Gynecologic Oncology — Fort Myers, Florida, United States
• MD Anderson Cancer Center-Baptist — Jacksonville, Florida, United States
• Baptist Health Medical Group Oncology, LLC — Miami, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Northside Hospital — Atlanta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Dr. Sudarshan K. Sharma, Ltd - Gynecologic Oncology — Hinsdale, Illinois, United States
• Ferrell-Duncan Clinic — Springfield, Illinois, United States
• Community Health Network — Indianapolis, Indiana, United States
• University of Iowa Hospitals — Iowa City, Iowa, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Maine Medical Center — Scarborough, Maine, United States
• Arizona Oncology Associates, PC - HAL — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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