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NCT03522246 · ClinicalTrials.gov registry record · Phase 3
A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
A Phase 3 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer, sponsored by pharmaand.
- Active
- Registry status
- Phase 3
- Development phase
- 1,097
- Enrollment target
- 20
- Study locations
NCT03522246: Active Phase 3 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer, sponsored by pharmaand.
NCT03522246 is a Phase 3 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer that is active but no longer recruiting, run by pharmaand. The registered enrollment target is 1,097 participants, above the 243-participant average among 85 other Fallopian Tube Cancer trials with a reported enrollment target (351% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03522246, a Phase 3 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer, is active but no longer recruiting, sponsored by pharmaand.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,097 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
PFS by investigator was defined as the time from randomization to disease progression, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,097 participants |
| Start Date | 2018-05-14 |
| Est. Completion | 2030-12-30 |
| Phase | Phase 3 |
What the registry record for NCT03522246 still lists
NCT03522246 is an interventional study that assigns participants to a tested intervention. Its 1,097 participants enrollment target places it among the larger protocols in the corpus, above the 243-participant average among 85 other Fallopian Tube Cancer trials with a reported enrollment target (351% higher).
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.
NCT03522246 names 20 study sites across 9 states, led by Florida, Arizona, California.
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.
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).
Who is sponsoring clinical trial NCT03522246?
This trial is sponsored by pharmaand, which has 15 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT03522246's enrollment target sits among peer trials
1,097 4th of 85 higher than 82 of 85 other Fallopian Tube Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fallopian Tube Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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