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NCT02631876 · ClinicalTrials.gov registry record · Phase 3
A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer
A Phase 3 study, sponsored by ImmunoGen.
- Completed
- Registry status
- Phase 3
- Development phase
- 366
- Enrollment target
NCT02631876: Completed Phase 3 study, sponsored by ImmunoGen.
NCT02631876 is a Phase 3 study that has completed, run by ImmunoGen. The registered enrollment target is 366 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02631876, a Phase 3 study, has completed, sponsored by ImmunoGen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 366 participants
- Enrollment target
Study Summary
This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of mirvetuximab soravtansine to that of selected single-agent chemotherapy (Investigator's choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or fallopian tube cancer.
Primary Outcome
PFS was defined as the time from randomization until PD or death whichever occurred first, estimated using the Kaplan-Meier method. 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 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal pro
Interventions
- DRUG Paclitaxel
- DRUG Topotecan
- DRUG Pegylated liposomal doxorubicin
- DRUG Mirvetuximab soravtansine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 366 participants |
| Start Date | 2016-03-02 |
| Est. Completion | 2020-01 |
| Phase | Phase 3 |
What the finished NCT02631876 record still lists
NCT02631876 is an interventional study that assigns participants to a tested intervention. The registered 366 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 4 interventions - of which Paclitaxel is the first listed.
NCT02631876 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02631876 about?
NCT02631876 is a clinical study titled "A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer". This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of mirvetuximab soravtansine to that of selected single-agent chemotherapy (Investigator's choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or fallopian t...
What is the current status of trial NCT02631876?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 366 participants. The study started on 2016-03-02. Estimated completion is 2020-01.
What interventions are being tested in trial NCT02631876?
The interventions under investigation include: Paclitaxel (DRUG), Topotecan (DRUG), Pegylated liposomal doxorubicin (DRUG), Mirvetuximab soravtansine (DRUG).
Who is sponsoring clinical trial NCT02631876?
This trial is sponsored by ImmunoGen, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02631876's enrollment target sits among peer trials
366 999th of 2000 higher than 1,000 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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