IMGN853-0420 is a multicenter, open-label, phase 2 study of carboplatin plus mirvetuximab soravtansine followed by mirvetuximab soravtansine continuation in folate receptor-alpha positive, recurrent platinum sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer following 1 prior line of platinum-based chemotherapy.
This Phase 2 study is designed to evaluate the efficacy and safety of MIRV in combination with carboplatin followed by MIRV continuation in FRα-positive participants with recurrent platinum-sensitive ovarian cancer (PSOC) following 1 prior line of platinum-based chemotherapy. Upon completion of carboplatin plus MIRV combination chemotherapy (6 cycles), participants without progressive disease will continue on single-agent MIRV. Participants must have confirmation of FRα positivity by the Ventana folate receptor 1 (FOLR1) Assay.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called FRα. It is being developed for the treatment of participants with recurrent platinum-sensitive, high grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with FRα expression. FRα positivity will be defined by the Ventana FOLR1 Assay.
Carboplatin is considered to be the treatment agent of choice in relapsed PSOC.
University of Arizona Cancer Center /ID# 268906
Tucson, Arizona, United States
Women'S Cancer Research Network - Cogi /ID# 268912
Fresno, California, United States
Providence - St. Jude Medical /ID# 268911
Fullerton, California, United States
Moores Cancer Center /ID# 268888
La Jolla, California, United States
USC Norris Comprehensive Cancer Center /ID# 268964
Los Angeles, California, United States
Overall Response Rate (ORR)
ORR following carboplatin plus MIRV combination as measured by the investigator and assessed according to RECIST v1.1, defined as the proportion of confirmed responders (CR or PR) among participants with FRα expression of ≥ 50% o ORR following carboplatin plus MIRV combination will also be measured, as a sensitivity analysis, by a blinded independent central review (BICR) in the same participant population
Time frame: Up to 3 years
Overall Response Rate (ORR)
ORR, defined as the proportion of confirmed responders (CR or PR) following carboplatin plus MIRV combination, as measured by the investigator and assessed according to RECIST v1.1, among patients with FRα expression of ≥ 25% of tumor cells with PS2+ staining intensity who have measurable disease per RECIST v1.1 at inclusion. o ORR will also be measured by a BICR, as a sensitivity analysis, in the same patient population.
Time frame: Up to 3 years
Duration of Response (DOR)
DOR, defined as the time from first response to radiological progressive disease (PD) or death, whichever occurs first, following carboplatin plus MIRV followed by MIRV continuation by the investigator and assessed according to RECIST v1.1 among efficacy evaluable participants: * with FRα expression of ≥ 50% of tumor cells with PS2+ staining and * with FRα expression of ≥ 25% of tumor cells with PS2+ staining * DOR in the above populations will also be measured by BICR
Time frame: Up to 3 years
Progression Free Survival (PFS)
PFS as measured by the investigator and by BICR in participants with * FRα expression of ≥ 50% of tumor cells with PS2+ staining and * FRα expression of ≥ 25% of tumor cells with PS2+ staining
Time frame: Up to 3 years
Overall Survival (OS)
OS in participants with * FRα expression of ≥ 50% of tumor cells with PS2+ staining and * FRα of ≥ 25% of tumor cells with PS2+ staining
Time frame: Up to 3 years
Cancer Antigen (CA)-125 Response
CA-125 response as measured by the investigator, per Gynecologic Cancer Intergroup (GCIG), in the efficacy evaluable participants with * FRα expression of ≥ 50% of tumor cells with PS2+ staining and * FRα expression of ≥ 25% of tumor cells with PS2+ staining
Time frame: Up to 3 years
Number of Participants With treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of California Los Angeles Medical Center /ID# 268883
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian /ID# 268907
Newport Beach, California, United States
UC Davis Comprehensive Cancer Center /ID# 269085
Sacramento, California, United States
Scripps Md Anderson - Prebys Cancer Center /ID# 268966
San Diego, California, United States
California Pacific Medical Center - Van Ness Campus /ID# 268886
San Francisco, California, United States
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