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- Withdrawn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 — DRUGThe dose will not be recalculated unless the patient has ±10% weight change.
- Bevacizumab — DRUGSubject 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | - |
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