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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
NCT04209855 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04209855
The ClinicalTrials.gov registry entry for NCT04209855 describes a study currently listed as completed. 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 453 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT04209855 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, California, Arizona. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04209855?
The interventions under investigation include: Paclitaxel (DRUG), Topotecan (DRUG), Pegylated liposomal doxorubicin (DRUG), Mirvetuximab Soravtansine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04209855?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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