A Phase II Evaluation of the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Persistent or Recurrent Endometrial Cancer
Alessandro Santin
Summary
The purpose of this study is to evaluate the activity and safety profile of mirvetuximab soravtansine (IMGN853) in patients with type II endometrial cancers that overexpress folate receptor alpha (FRα).
Description
This study will enroll patients with persistent or recurrent FRα-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 car…
Eligibility
- Age range
- 18–100 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Radiologically confirmed (ie, CT scan and/or MRI) persistent or recurrent endometrial cancer * Patients must have one of the following pathologically documented, definitively diagnosed tumor types: Uterine serous carcinoma (Pure or Mixed), Grade 2 or Grade 3 endometrial adenocarcinoma, Carcinosarcoma with high grade serous or Grade 2/3 endometrioid components, or clear cell carcinoma (Pure or Mixed). * Have measurable disease * FRα-positive tumor expression as defined in the protocol * Have at least one "target lesion" to be used to assess response as defined by RECIST v…
Interventions
- DrugIMGN853
IMGN853 6 mg/kg intravenously every 3 weeks until disease progression
Location
- Smilow Cancer Hospital at Yale New HavenNew Haven, Connecticut