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

• Status: Completed
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ImmunoGen, Inc.
• Collaborator: Gynecologic Oncology Group
• Treatments: Antibodies; Doxorubicin; Liposomal doxorubicin; Maytansine; Paclitaxel; Topotecan

Criteria

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