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

Completed · Phase 3

Conditions studied: Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer, Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT02631876

Run by

ImmunoGen, Inc.

People needed

366

Starts

2016-03-02

Expected to finish

2020-01-01

Last updated by the study team

2020-10-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Participants must be diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer
• Participants must have folate receptor alpha positive tumor expression as defined in the protocol
• Participants must have platinum-resistant ovarian cancer, defined as progression within 6 months from completion of a minimum of four cycles of platinum-containing therapy.
• Participants 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
• Participants must have at least one lesion that meets the definition of measurable disease by RECIST 1.1

You may not qualify if…

• Diagnosis of clear cell, low grade ovarian cancer or mixed tumors
• Participants with primary platinum-refractory disease
• Serious concurrent illness or clinically relevant active infection as defined in the protocol
• Prior treatment with mirvetuximab soravtansine
• Women who are pregnant or breast feeding

Where it is running

• Arizona Oncology Associates, PC - HAL — Tempe, Arizona, United States
• Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
• UCLA Women's Health Clinical Research Unit - OBGYN — Los Angeles, California, United States
• University of California San Diego Medical Center — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Kaiser Permanente Medical Center — Vallejo, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Norwalk Hospital/WCHN — Norwalk, Connecticut, United States
• Florida State University College of Medicine — Sarasota, Florida, United States
• Georgia Regents University (GRU)-Medical College of Georgia (MCG) - Cancer Center — Augusta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Sudarshan Sharma LTD — Hinsdale, Illinois, United States
• Community Health Network, Inc. — Indianapolis, Indiana, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Women's Cancer Care — Covington, Louisiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• WK Physician Network Clinical Research — Shreveport, Louisiana, United States
• Holy Cross Hospital — Silver Spring, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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