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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
Trial Status: complete
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.
Inclusion Criteria
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
Exclusion Criteria
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02631876.
