PH3 Study of Mirvetuximab Soravtansine vs Investigator's Choice of Chemotherapy in Women With FRa+ Adv. EOC, Primary Peritoneal or Fallopian Tube Cancer

Study ID
STU 102016-066

Study Sites

  • UT Southwestern Ambulatory Services

Contact
Annette Paulsen
214/648-2290
ANNETTE.PAULSEN@UTSouthwestern.edu

Principal Investigator
David Miller, M.D.

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

Brief Overview

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.

Description

Patients will be randomized to either IMGN853 or Investigator's Choice chemotherapy.

Eligibility

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