Overview

This trial was last updated 4 days ago.
Conditions epithelial ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer, ovarian cancer
Treatments imgn853, paclitaxel, doxorubicin, topotecan
Phase phase 3
Target folate receptor alpha
Sponsor ImmunoGen, Inc.
Collaborator Gynecologic Oncology Group
Start date December 2015
End date November 2018
Trial size 333 participants
Trial identifier NCT02631876, IMGN0403

Summary

This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of IMGN853 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.

Recruiting in the following locations…

United States Illinois, Ohio, and Oklahoma
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
IMGN853 administered at 6 mg/kg AIBW once every three weeks (Q3W)
imgn853 mirvetuximab soravtansine
(Experimental)
Paclitaxel, Pegylated Liposomal Doxorubicin, or Topotecan
paclitaxel
doxorubicin Pegylated Liposomal Doxorubicin
topotecan

Primary Outcomes

Measure
Progression free survival in all patients randomized to the study and in patients with high folate receptor alpha expression
time frame: Up to 2 years

Secondary Outcomes

Measure
Objective response rate (ORR) per RECIST1.1
time frame: Up to 2 years
Overall survival (OS) as measured from the date of randomization until the date of death.
time frame: Up to 2 years
Quality of life
time frame: Up to 2 years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer - Folate receptor alpha positive tumor expression as defined in the protocol - Patients must have platinum-resistant ovarian cancer, defined as progression within 6 months from completion of a minimum of four cycles of platinum-containing therapy. - Patients must have received at least one but no more than three prior systemic treatment regimens and for whom single-agent chemotherapy is appropriate as the next line of treatment - Patients must have at least one lesion that meets the definition of measurable disease by RECIST 1.1 Exclusion Criteria: - Diagnosis of clear cell or low grade ovarian cancer - Patients with primary platinum-refractory disease - Serious concurrent illness or clinically relevant active infection as defined in the protocol - Prior treatment with IMGN853 - Women who are pregnant or breast feeding

Additional Information

Official title 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
Description Patients will be randomized to either IMGN853 or Investigator's Choice chemotherapy.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by ImmunoGen, Inc..