Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Study of IMGN853 in Comb. With Bevacizumab, Carboplatin, PLD or Pembrolizumab in Adults With FRa + Adv. EOC, Primary Peritoneal, Fallopian Tube, or Endometrial Cancer

Protocol: OSU-15186

Full Title

A Phase Ib Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Mirvetuximab Soravtansine (IMGN853) in Combination with Bevacizumab, Carboplatin or Pegylated Liposomal Doxorubicin in Adults with Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, or Endometrial Cancer

Purpose

This is a phase 1b study to assess the safety, tolerability, and preliminary anti-tumor

activity of IMGN853 when administered with chemotherapy. Patients will be assigned to one of

four regimens: IMGN853 administered with bevacizumab, IMGN853 administered with carboplatin,

IMGN853 administered with pegylated liposomal doxorubicin or IMGN853 administered with

pembrolizumab.

Study Objective

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.

Are you eligible?

Inclusion Criteria:

Diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer,

fallopian tube cancer, or endometrial cancer

Folate receptor alpha positive tumor expression as defined in the protocol

Willing to undergo tumor biopsy

Exclusion Criteria:

Primary platinum refractory

Diagnosis of clear cell or low grade ovarian cancer

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 breast feeding

Gynecologic Cancers Ovarian Cancer