Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer

Launched by ALESSANDRO SANTIN · Feb 5, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called mirvetuximab soravtansine (IMGN853) for women with a specific type of endometrial cancer that has certain characteristics, particularly those that have a high level of a protein called folate receptor alpha. The goal is to see how effective and safe this treatment is for women whose cancer has come back after previous therapies. The trial is currently recruiting participants who are 18 years or older and have been diagnosed with specific types of endometrial cancer, such as uterine serous carcinoma or clear cell carcinoma.

To be eligible for the trial, participants must have cancer that can be measured and must have had up to three prior treatments for their recurrent cancer. They should also be in good overall health and have no serious heart or neurological conditions. Participants can expect to receive the study treatment and will have regular check-ups to monitor their health and how well the treatment is working. It’s important that women who can become pregnant agree to use effective birth control during the study and for a period afterward. This trial aims to provide more options for women facing recurrent endometrial cancer and contribute to our understanding of this disease.

Gender

FEMALE

Eligibility criteria

• 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