Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT03836157|
Recruitment Status : Withdrawn (Study was not initiated.)
First Posted : February 11, 2019
Last Update Posted : June 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer Endometrial Adenocarcinoma Endometrial Serous Adenocarcinoma Endometrial Clear Cell Adenocarcinoma||Drug: Mirvetuximab Soravtansine Drug: Bevacizumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer|
|Estimated Study Start Date :||May 31, 2019|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||May 2022|
Experimental: Mirvetuximab and Bevacizumab
Drug: Mirvetuximab Soravtansine
The dose will not be recalculated unless the patient has ±10% weight change.
Other Name: IMGN853
Subject will receive IMGN853 first followed by bevacizumab. There is no planned delay between the IMGN853 and bevacizumab administration.
- Response rate of patients who remain progression free [ Time Frame: 6 months ]
- Percentage of patients who remain progression free [ Time Frame: 6 months ]
- Incidence of adverse events [ Time Frame: up to 3 years ]
- Progression free survival [ Time Frame: up to 3 years ]
- Overall survival [ Time Frame: up to 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836157
|United States, Oklahoma|
|Stephenson Cancer Center|
|Oklahoma City, Oklahoma, United States, 73104|