Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-? Positive Endometrial Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Endometrial Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 100 years
- Gender
- Only males
Description
This study will enroll patients with persistent or recurrent FR?-positive uterine serous carcinoma (pure or mixed), Grade 3 endometrial adenocarcinoma, or carcinosarcoma with high grade serous or Grade 3 endometrioid components. All patients must have measurable disease. The primary objective of the...
This study will enroll patients with persistent or recurrent FR?-positive uterine serous carcinoma (pure or mixed), Grade 3 endometrial adenocarcinoma, or carcinosarcoma with high grade serous or Grade 3 endometrioid components. All patients must have measurable disease. The primary objective of the study is to assess the activity of IMGN853 as measured by objective response rate (ORR). The secondary objectives are to assess the duration of overall survival (OS), progression-free survival (PFS) and durable disease control rate (DDCR), as well as the safety profile of IMGN853 in endometrial carcinoma patients. Exploratory/correlative objectives are to correlate ORR, PFS, and OS with the level of folate receptor ? expression and explore use of circulating tumor (ct) DNA as a biomarker for disease response and compare its performance to cancer antigen 125 (CA-125). All enrolled patients will receive IMGN853 at a dose of 6 mg/kg administered intravenously once every 3 weeks until unacceptable toxicity or progression of disease requiring discontinuation of treatment.
Tracking Information
- NCT #
- NCT03832361
- Collaborators
- ImmunoGen, Inc.
- Investigators
- Principal Investigator: Alessandro D. Santin, M.D. Yale University