Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT03836157
Phase
PHASE2
Status
Withdrawn

Conditions

  • Endometrial Adenocarcinoma
  • Endometrial Cancer
  • Endometrial Clear Cell Adenocarcinoma
  • Endometrial Serous Adenocarcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mirvetuximab Soravtansine — DRUG
    The dose will not be recalculated unless the patient has ±10% weight change.
  • Bevacizumab — DRUG
    Subject will receive IMGN853 first followed by bevacizumab. There is no planned delay between the IMGN853 and bevacizumab administration.

Study Details

IMGN853 is designed to inhibit cell division and cell growth of folate receptor 1 (FRα)-expressing tumor cells. The purpose of this study is to test the safety of IMGN853 and bevacizumab and see what effects (good and bad) that this combination treatment has on subjects with recurrent endometrial cancer.

Key Dates

First listed
Feb 11, 2019
Start date
May 31, 2019
Status verified
Jun 2019
Primary completion
Nov 30, 2021
Completion
May 31, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mirvetuximab and Bevacizumab
    * Mirvetuximab Soravtansine 6mg/kg IV (adjusted ideal body weight), on day 1 of each 21 day cycle. * Bevacizumab 15 mg/kg, IV, on day 1 of each 21-day cycle.

Primary Outcome Measure

Response rate of patients who remain progression free [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stephenson Cancer CenterOklahoma CityOklahoma73104-

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