Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-05 @ 6:23 PM
Study NCT ID:
NCT03836157
Status:
WITHDRAWN
Last Update Posted:
2019-06-27
First Post:
2019-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer
Sponsor:
University of Oklahoma
Organization:
Study Overview
Official Title:
Phase II Trial of Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer
Status:
WITHDRAWN
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was not initiated.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: