NCT03832361
Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentAlessandro SantinInvestigator-initiated
~50 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:IMGN853
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR)
Measured over 5 Years
Conditions
Where it's being run
1 sites across 1 statesConnecticut1
Study leadership
- Alessandro D. Santin, M.D. · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
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Do you actually qualify for this trial?
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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
What this trial measures
- Objective response rate (ORR)5 Years
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