A Phase 2 Study of Mirvetuximab Soravtansine (IMGN853) and Pembrolizumab in Endometrial Cancer (EC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03835819|
Recruitment Status : Not yet recruiting
First Posted : February 11, 2019
Last Update Posted : February 11, 2019
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)
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: Pembrolizumab Drug: IMGN853||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Estimated Study Start Date :||March 31, 2019|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||October 1, 2023|
Experimental: IMGN853 + Pembrolizumab
Pembrolizumab is an immunotherapy that activates a patient's own immune system to recognize and kill tumor cells
Mirvetuximab soravtansine is an antibody-drug conjugate.
Other Name: Mirvetuximab soravtansine
- Objective Response Rate [ Time Frame: 6 months ]
- Progression Free Survival [ Time Frame: 6 months ]
- Duration of response [ Time Frame: 2 years ]
- Overall Survival [ Time Frame: 2 Years ]
- Immune-related progression-free survival [ Time Frame: 2 years ]
- Immune-related progression of disease [ Time Frame: 2 Years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835819
|Contact: Panagiotis Konstantinopoulos, MD, PhD||617-632-2334||Panagiotis_Konstantinopoulos@DFCI.HARVARD.EDU|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Oladapo O Yeku, MD email@example.com|
|Principal Investigator: Oladapo O Yeku, MD|
|Beth Israel Deaconess Medical Center||Not yet recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Meghan Shea, MD firstname.lastname@example.org|
|Principal Investigator: Meghan Shea, MD|
|Dana Farber Cancer Institute||Not yet recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Panagiotis Konstantinopoulos, MD, PhD 617-632-2334 Panagiotis_Konstantinopoulos@DFCI.HARVARD.EDU|
|Principal Investigator: Panagiotis Konstantinopoulos, MD, PhD|
|Principal Investigator:||Panagiotis Konstantinopoulos, MD,PhD||Dana-Farber Cancer Institute|