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ACTIVE NOT RECRUITING Phase 3

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

NCT03522246 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Nivolumab
  • DRUG Placebo Oral Tablet
  • DRUG Rucaparib
  • DRUG Placebo IV Infusion

Study Locations (20)

Florida

  • Florida Gynecologic Oncology — Fort Myers
  • MD Anderson Cancer Center-Baptist — Jacksonville
  • Baptist Health Medical Group Oncology, LLC — Miami
  • Florida Hospital — Orlando

Arizona

  • Arizona Oncology Associates, PC - HAL — Phoenix
  • Arizona Oncology Associates, PC - HOPE — Tucson
  • The University of Arizona Cancer Center — Tucson

California

  • John Muir Clinical Research Center — Concord
  • UCLA Women's Health Clinical Research Unit — Los Angeles
  • Kaiser Permanente Northern California — San Francisco

Illinois

  • Rush University Medical Center — Chicago
  • Dr. Sudarshan K. Sharma, Ltd - Gynecologic Oncology — Hinsdale
  • Ferrell-Duncan Clinic — Springfield

Colorado

  • University of Colorado Cancer Center — Aurora
  • Rocky Mountain Cancer Centers — Lakewood

Georgia

  • Northside Hospital — Atlanta
  • Augusta University — Augusta

Connecticut

  • Yale University — New Haven

Indiana

  • Community Health Network — Indianapolis

Trial Details

FieldValue
Enrollment Target 1,097 participants
Start Date 2018-05-14
Est. Completion 2030-12-30
Phase Phase 3

Sponsor

pharmaand

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03522246

The ClinicalTrials.gov registry entry for NCT03522246 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,097 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is pharmaand, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 7 conditions, with Fallopian Tube Cancer appearing as the primary indexed condition, and to 4 interventions — of which Nivolumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03522246 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03522246 about?

NCT03522246 is a clinical study titled "A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy". 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 homologo...

What is the current status of trial NCT03522246?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,097 participants. The study started on 2018-05-14. Estimated completion is 2030-12-30.

What conditions does trial NCT03522246 study?

This clinical trial studies the following conditions: Fallopian Tube Cancer, Epithelial Ovarian Cancer, Newly Diagnosed, Primary Peritoneal, FIGO Stage III-IV. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03522246?

The interventions under investigation include: Nivolumab (DRUG), Placebo Oral Tablet (DRUG), Rucaparib (DRUG), Placebo IV Infusion (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03522246?

This trial is sponsored by pharmaand, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03522246 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial