A Phase 2 Study of Mirvetuximab Soravtansine (IMGN853) and Pembrolizumab in Endometrial Cancer (EC)

Summary

Participation Requirements

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 Administrati...

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 (FR?). FR? 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 FR?. To participate in this study, a sample of your tumor was previously tested, and was found to have high levels of FR?. 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

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