CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 366 enrolled
Drug / intervention
Mirvetuximab soravtansine +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02631876
NCT02631876Phase 3Completed
CompareCT.gov

FORWARD I: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

ImmunoGen, Inc.·interventional·Posted Dec 16, 2015·Updated Oct 14, 2020

In Brief

A Phase 3 clinical trial evaluating Mirvetuximab soravtansine, Paclitaxel, and 2 other interventions for Epithelial Ovarian Cancer and 3 related conditions. Completed, enrolled 366 participants across 131 sites in 13 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpithelial Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer, Ovarian Cancer
CountriesBelgium, Bosnia and Herzegovina, Canada, Czechia, France, Ireland, Italy, Russia, Serbia, Spain, Switzerland, United Kingdom, United States
CollaboratorsGynecologic Oncology Group

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 16, 2015
Enrollment StartMar 2, 2016
Primary CompletionJan 1, 2019
Study CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.5 years ago

Interventions

Mirvetuximab soravtansinedrug

Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.

Paclitaxeldrug

Paclitaxel will be administered per dose and schedule specified in the arm.

Pegylated liposomal doxorubicindrug

Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm.

Topotecandrug

Topotecan will be administered per dose and schedule specified in the arm.