Status:
RECRUITING
Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer
Lead Sponsor:
Alessandro Santin
Collaborating Sponsors:
ImmunoGen, Inc.
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18-100 years
Phase:
PHASE2
Brief 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...
Detailed 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 Grad...
Eligibility Criteria
Inclusion
- 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 v1.1
- Patients must have received prior treatment with ≤ 3 prior lines of therapy for recurrent disease; hormonal agents are not considered a line of therapy; prior treatment with folate receptor-targeting investigational agents is not allowed
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Time from prior therapy: Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is shorter; Radiotherapy: wide-field radiotherapy completed at least four weeks, or focal radiation completed at least two weeks, prior to starting study treatment
- Patients must have resolution of toxic effect(s) of the most recent prior chemotherapy
- Patients must have adequate hematologic, liver and kidney function as defined in the protocol
- Women of child bearing potential (WCBP), must agree to use effective contraceptive methods during study treatment and for at least twelve weeks after the last dose of IMGN853
- WCBP must have a negative pregnancy test within 4 days prior to the first dose of study treatment
- At time of initial surgery, patient may have either been optimally or suboptimally debulked
- Have signed the informed consent form, and willing to adhere to the study visit schedule and other protocol requirements
- ≥ 18 years of age
Exclusion
- 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
- History of hemorrhagic or ischemic stroke within the last 6 months
- History of cirrhotic liver disease
- Previous clinical diagnosis of non-infectious pneumonitis
- Prior hypersensitivity to monoclonal antibodies
- Women who are pregnant or breast feeding
- Carcinomatous meningitis, untreated central nervous system (CNS) disease or symptomatic CNS metastasis
- History or evidence of thrombotic or hemorrhagic disorders within 6 months before first study treatment
- Required used of folate-containing supplements (e.g. folate deficiency)
- Has a known additional malignancy that is progressing or required active treatment within 3 years of first dose of study treatment
Key Trial Info
Start Date :
July 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03832361
Start Date
July 15 2020
End Date
October 1 2028
Last Update
July 18 2025
Active Locations (1)
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1
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States, 06510