RSH_IMGN0403

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

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
Phase III
NCT02631876
Cancer, All Other
Gynecologic
Ying Zhuo, M.D.
ImmunoGen
Megan Greenough
  • Kadlec Research