Study of Mirvetuximab Soravtansine in Comb. With Bevacizumab, Carboplatin, PLD, Pembrolizumab, or Bevacizumab + Carboplatin in Adults With FRa + Adv. EOC, Primary Peritoneal or Fallopian Tube Cancer

Status: Closed to Accrual

Description

This is a phase 1b / 2 study to assess the safety, tolerability, and preliminary anti-tumor activity of IMGN853 when administered with chemotherapy. Patients will be assigned to one of five regimens: IMGN853 administered with bevacizumab, IMGN853 administered with carboplatin, IMGN853 administered with pegylated liposomal doxorubicin, IMGN853 administered with pembrolizumab, or IMGN853 administered with bevacizumab+carboplatin

Eligibility Criteria

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
  • Willing to undergo tumor biopsy
  • Measurable disease

Exclusion Criteria

  • Primary platinum-refractory EOC
  • Diagnosis of clear cell, low grade ovarian cancer or mixed tumors
  • Serious concurrent illness or clinically relevant active infection, including known diagnosis of HIV and hepatitis B or C, as defined in the protocol
  • Active autoimmune disease requiring systemic therapy in past 2 years (IMGN853 and pembrolizumab only)
  • Women who are pregnant or breastfeeding
  • Male patients

Locations & Contacts

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Contact: Michael James Birrer
Phone: 205-934-5077
Email: mbirrer@uab.edu

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Approved
Contact: Ross Divinagracia
Phone: 310-825-0580
Email: rossmar@mednet.ucla.edu

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: Approved
Name Not Available

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: David M. O'Malley
Phone: 614-293-3145

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not Available

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

The dose escalation part of the study will assess safety and tolerability and determine the maximum tolerated dose (MTD) for each regimen. The dose expansion of the MTD will assess safety, tolerability and preliminary anti-tumor activity.

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
ImmunoGen Inc

Trial IDs

Primary ID IMGN853-0402
Secondary IDs NCI-2016-00530, KEYNOTE PN409, Keynote-409, IMGN0402
Clinicaltrials.gov ID NCT02606305