Summary

for females ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion

Description

Summary

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.

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

Details

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

Keywords

Epithelial Ovarian CancerPrimary Peritoneal CarcinomaFallopian Tube CancerOvarian CancerPrimary peritoneal cancerIMGN853ADCAntibody drug conjugateImmunoGenAntibodyFolate receptor alphamirvetuximab soravtansinePhase 3platinum-resistantOvarian NeoplasmsCarcinoma, Ovarian EpithelialFallopian Tube NeoplasmsPaclitaxelMaytansineDoxorubicinLiposomal doxorubicinTopotecanAntibodiesImmunoconjugates

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego Medical Center
    San DiegoCalifornia92093United States
  • UCLA Women's Health Clinical Research Unit - OBGYN
    Los AngelesCalifornia90095United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ImmunoGen, Inc.
ID
NCT02631876
Phase
Phase 3
Study Type
Interventional
Last Updated