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Brief Title: A Phase 2 Study of Mirvetuximab Soravtansine (IMGN853) and Pembrolizumab in Endometrial Cancer (EC)
Official Title: A Phase 2, Two-stage, Study of Mirvetuximab Soravtansine (IMGN853) in Combination With Pembrolizumab in Patients With Microsatellite Stable (MSS) Recurrent or Persistent Endometrial Cancer (EC)
Study ID: NCT03835819
Brief Summary: This research study is studying a drug combination as a possible treatment for endometrial cancer. The drugs involved in this study are: * mirvetuximab soravtansine (IMGN853) * pembrolizumab
Detailed Description: This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved mirvetuximab soravtansine as a treatment for any disease. The FDA (the U.S. Food and Drug Administration) has not approved pembrolizumab for this specific disease but it has been approved for other uses. In this research study, the investigators are studying the combination of mirvetuximab soravtansine and pembrolizumab. Pembrolizumab is an immunotherapy that activates a patient's own immune system to recognize and kill tumor cells. Pembrolizumab by itself may not be enough to kill cancer cells in all people with cancer. In this study, all patients will receive mirvetuximab soravtansine and pembrolizumab. Mirvetuximab soravtansine is an antibody-drug conjugate. That is a type of agent that attaches a chemotherapy drug to a molecule that binds a protein on the outside of cancer cells. The protein targeted by mirvetuximab soravtansine is called folate receptor-alpha (FRα). FRα is expressed on the surface of certain cancers, including endometrial cancer cells. Mirvetuximab soravtansine is expected to kill cancer cells by delivering chemotherapy to cells that have high levels of FRα. To participate in this study, a sample of your tumor was previously tested, and was found to have high levels of FRα. Mirvetuximab soravtansine also may also active immune cells and improve the response to immunotherapies like pembrolizumab. In this study, the investigators expect to learn whether the combination of pembrolizumab and mirvetuximab soravtansine can shrink endometrial cancers or prevent their growth for at least 6 months. The investigators will also learn more about the side effects patients experience who receive this treatment. The investigators also plan to learn more about which patients are likely to benefit from this treatment
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Massachusetts, Worcester, Massachusetts, United States
Northwell Cancer Institute, Lake Success, New York, United States
Name: Rebecca Porter, MD, PhD
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR