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NCT04209855 · ClinicalTrials.gov registry record · Phase 3
A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression
A Phase 3 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 453
- Enrollment target
- 20
- Study locations
NCT04209855: Completed Phase 3 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer, sponsored by AbbVie.
NCT04209855 is a Phase 3 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer that has completed, run by AbbVie. The registered enrollment target is 453 participants, above the 250-participant average among 85 other Fallopian Tube Cancer trials with a reported enrollment target (81% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04209855, a Phase 3 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 453 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine (MIRV) vs. IC chemotherapy in participants with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. The FRα positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.
Primary Outcome
PFS was defined as the time from randomization until progressive disease (PD) or death whichever occurred first. PD: At least a 20% increase in the sum of the longest diameters (SoD) of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 millimeters (mm). Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progress
Conditions Studied
Interventions
- DRUG Paclitaxel
- DRUG Topotecan
- DRUG Pegylated liposomal doxorubicin
- DRUG Mirvetuximab Soravtansine
Study Locations (20)
Florida
- Florida Cancer Specialist South Division - Fort Myers
- Mayo Clinic Jacksonville - Jacksonville
- Sarasota Memorial Hospital - Sarasota
- Women's Care Florida / Women's Cancer Associates - St. Petersburg
- Florida Cancer Specialist North Division - St. Petersburg
- Florida Cancer Specialists - Tallahassee
- Florida Cancer Specialist East Division - West Palm Beach
California
- UCLA - JCCC Dept of OBGYN - Women's Health Clinical Research Unit - Los Angeles
- Hoag Cancer Center - Newport Beach
- University of California San Francisco - San Francisco
- Olive View - UCLA Medical Center - Sylmar
- Kaiser Permanente Oncology Clinical Trials - Vallejo
Arizona
- Arizona Oncology Associates, PC - HAL - USOR - Phoenix
- Mayo Clinic - Phoenix
- USOR: Arizona Oncology Associates, PC - HOPE - Tucson
- University of Arizona Cancer Center - Tucson
Alabama
- University of Alabama at Birmingham (UAB) GYN Oncology - Birmingham
Alaska
- Alaska Women's Cancer Care - Anchorage
Colorado
- USOR: Rocky Mountain Cancer Centers - Lakewood
Connecticut
- Yale University School of Medicine - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 453 participants |
| Start Date | 2019-12-31 |
| Est. Completion | 2024-10-29 |
| Phase | Phase 3 |
What the finished NCT04209855 record still lists
NCT04209855 is an interventional study that assigns participants to a tested intervention. The registered 453 participants enrollment target is mid-sized for trials with a published cap, above the 250-participant average among 85 other Fallopian Tube Cancer trials with a reported enrollment target (81% higher).
The record links to 3 conditions, with Fallopian Tube Cancer appearing as the primary indexed condition, and to 4 interventions - of which Paclitaxel is the first listed.
NCT04209855 names 20 study sites across 7 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04209855 about?
NCT04209855 is a clinical study titled "A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression". This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine (MIRV) vs. IC chemotherapy in participants with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Participants...
What is the current status of trial NCT04209855?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 453 participants. The study started on 2019-12-31. Estimated completion is 2024-10-29.
What conditions does trial NCT04209855 study?
This clinical trial studies the following conditions: Fallopian Tube Cancer, Epithelial Ovarian Cancer, Peritoneal Cancer.
What interventions are being tested in trial NCT04209855?
The interventions under investigation include: Paclitaxel (DRUG), Topotecan (DRUG), Pegylated liposomal doxorubicin (DRUG), Mirvetuximab Soravtansine (DRUG).
Who is sponsoring clinical trial NCT04209855?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04209855 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04209855's enrollment target sits among peer trials
453 12th of 85 higher than 74 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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