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NCT04296890 · ClinicalTrials.gov registry record · Phase 3
A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression
A Phase 3 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer, sponsored by ImmunoGen.
- Completed
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
- 20
- Study locations
NCT04296890: Completed Phase 3 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer, sponsored by ImmunoGen.
NCT04296890 is a Phase 3 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer that has completed, run by ImmunoGen. The registered enrollment target is 106 participants, below the 255-participant average among 85 other Fallopian Tube Cancer trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04296890, a Phase 3 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer, has completed, sponsored by ImmunoGen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 106 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in participants with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate Receptor-Alpha (FRα). Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. All participants will receive single-agent MIRV at 6 mg/kg adjusted ideal body weight administered on Day 1 of every 3-week cycle.
Primary Outcome
ORR was defined as percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.
Conditions Studied
Interventions
- DRUG Mirvetuximab Soravtansine
Study Locations (20)
California
- City of Hope Medical Center - Duarte
- California Cancer Associates (cCARE) - Fresno
- Stanford School of Medicine - Palo Alto
- California Pacific Medical Center Research Institute - San Francisco
Florida
- Sarasota Memorial Health Care System - Sarasota
- Florida Cancer Specialists Panhandle - Tallahassee
- University of South Florida - Tampa
- Florida Cancer Specialists Research - West Palm Beach
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
Arizona
- Arizona Oncology Associates - Phoenix
Colorado
- Rocky Mountain Cancer Centers - Littleton
Georgia
- Northside Hospital - Atlanta
Illinois
- Hinsdale Hospital - Hinsdale
Indiana
- St. Vincent Gynecologic Oncology - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2020-07-23 |
| Est. Completion | 2022-11-16 |
| Phase | Phase 3 |
What the finished NCT04296890 record still lists
NCT04296890 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 255-participant average among 85 other Fallopian Tube Cancer trials with a reported enrollment target (58% lower).
The record links to 3 conditions, with Fallopian Tube Cancer appearing as the primary indexed condition, and to 1 intervention - of which Mirvetuximab Soravtansine is the first listed.
NCT04296890 names 20 study sites across 13 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04296890 about?
NCT04296890 is a clinical study titled "A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression". This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in participants with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate Receptor-Alpha (FRα). Particip...
What is the current status of trial NCT04296890?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2020-07-23. Estimated completion is 2022-11-16.
What conditions does trial NCT04296890 study?
This clinical trial studies the following conditions: Fallopian Tube Cancer, Epithelial Ovarian Cancer, Peritoneal Cancer.
What interventions are being tested in trial NCT04296890?
The interventions under investigation include: Mirvetuximab Soravtansine (DRUG).
Who is sponsoring clinical trial NCT04296890?
This trial is sponsored by ImmunoGen, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04296890 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04296890's enrollment target sits among peer trials
106 33rd of 85 higher than 53 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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