Trials / Withdrawn
WithdrawnNCT03836157
Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer
Phase II Trial of Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Oklahoma · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
SCREENING: During the screening portion of the study, the subject will need to have tumor tissue tested and other exams to determine if s/he may proceed to the treatment part of the study. The subject's tumor tissue will be tested from either a previous or recent surgery or biopsy to see if it contains the FRα protein. If the tumor is positive and the patient meets all other eligibility, then the subject may proceed to treatment. TREATMENT: Study drugs (IMGN853 and bevacizumab) will be given by vein (IV) once each cycle on day 1 of 21 day cycle. Regular cancer care exams, tests, and procedures will occur. Additionally, an eye doctor visit with complete eye examination every other treatment cycle. Subjects will also self-administer eye drops as prescribed by the eye doctor. Study participation is up to three years.
Conditions
- Endometrial Cancer
- Endometrial Adenocarcinoma
- Endometrial Serous Adenocarcinoma
- Endometrial Clear Cell Adenocarcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mirvetuximab Soravtansine | The dose will not be recalculated unless the patient has ±10% weight change. |
| DRUG | Bevacizumab | Subject will receive IMGN853 first followed by bevacizumab. There is no planned delay between the IMGN853 and bevacizumab administration. |
Timeline
- Start date
- 2019-05-31
- Primary completion
- 2021-11-30
- Completion
- 2022-05-01
- First posted
- 2019-02-11
- Last updated
- 2019-06-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03836157. Inclusion in this directory is not an endorsement.