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).
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
Active or chronic corneal disorder
Serious concurrent illness or clinically-relevant active infection as defined in the protocol
Clinically-significant cardiac disease such as recent myocardial infarction (≤ 6 months prior to day 1), unstable angina pectoris, uncontrolled congestive heart failure, uncontrolled hypertension, prior history of hypertensive crisis or hypertensive encephalopathy, uncontrolled cardiac arrhythmias, clinically-significant vascular disease, severe aortic stenosis, clinically significant peripheral vascular disease, or cardiac toxicity following prior chemotherapy
History of neurological conditions
Single group
IMGN853
DrugIMGN853 6 mg/kg intravenously every 3 weeks until disease progression
Objective response rate (ORR)
Objective response rate (complete response and partial response rates) by RECIST 1.1 criteria of mirvetuximab soravtansine in patients with folate receptor α-positive persistent or recurrent endometrial cancer
Duration of overall survival (OS)
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Duration of progression free survival (PFS)
Progression-free survival is defined as the duration of time from study entry to time of progression, death, or the date of last contact, whichever occurs first.
Durable disease control rate (DDCR)
The percentage of patients who have achieved complete response, partial response, and stable disease.
Safety profile of mirvetuximab soravtansine (IMGN853) in endometrial cancer patients (adverse events as assessed by CTCAE v5.0)
Incidence of treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
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Alessandro Santin
Lead sponsor
Yale University
Sponsor institution
ImmunoGen, Inc.
Collaborator
AbbVie
Collaborator
