Evaluating a new treatment for women with specific types of endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the effectiveness and safety of mirvetuximab soravtansine (IMGN853) in women diagnosed with type II endometrial cancers that express folate receptor alpha (FRα). Participants will include those with persistent or recurrent uterine serous carcinoma, Grade 3 endometrial adenocarcinoma, or carcinosarcoma with high-grade components. The study will measure the objective response rate (ORR) as the primary outcome, while secondary outcomes will include overall survival (OS), progression-free survival (PFS), and safety assessments. Patients will receive IMGN853 intravenously every three weeks until disease progression or unacceptable toxicity occurs.

Why it matters

Who can join: the full rules

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 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 Criteria:

* 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

Where it's running

• Smilow Cancer Hospital at Yale New Haven
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Alessandro D. Santin, M.D. — Yale University
• Study coordinator: Alessandro D. Santin, M.D.
• Email: alessandro.santin@yale.edu
• Phone: 203-737-4450

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.