Phase 2 Study of Mirvetuximab Soravtansine and Pembrolizumab for Endometrial Cancer
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT03835819
This clinical trial is exploring a new combination of drugs, mirvetuximab soravtansine and pembrolizumab, to see if they can effectively treat endometrial cancer. The study aims to determine if this combination can shrink tumors or stop them from growing for at least six months.
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Program Overview
This study is testing a combination of two drugs, mirvetuximab soravtansine and pembrolizumab, to see if they can help treat endometrial cancer. Mirvetuximab soravtansine is designed to deliver chemotherapy directly to cancer cells that have a specific protein, while pembrolizumab helps the immune system attack cancer cells. The study will look at whether this combination can reduce the size of tumors or prevent them from growing for at least six months. Researchers will also monitor any side effects and try to identify which patients might benefit the most from this treatment.
Description
This Phase II clinical trial is investigating the safety and effectiveness of a new drug combination for treating endometrial cancer. Mirvetuximab soravtansine is an antibody-drug conjugate that targets a protein called folate receptor-alpha (FRα) found on certain cancer cells, including those in endometrial cancer. It delivers chemotherapy directly to these cells. Pembrolizumab is an immunotherapy that helps the immune system recognize and attack cancer cells. Although these drugs are not yet approved by the FDA for endometrial cancer, they have been approved for other uses. In this study, all participants will receive both drugs to see if the combination can shrink tumors or stop them from growing for at least six months. Researchers will also study the side effects and try to determine which patients are most likely to benefit from this treatment.
Eligibility Criteria
Inclusion Criteria
- Have advanced or recurrent serous endometrial cancer, with the serous type being the main part of the tumor.
- The cancer must be microsatellite stable (MSS) and have high levels of the FRα protein.
- Have measurable disease that can be tracked using standard criteria.
- Have had one to three previous chemotherapy treatments for endometrial cancer.
- Previous hormonal therapy is allowed and does not count as a prior treatment.
- Previous immunotherapy targeting the PD-1/PD-L1 pathway is allowed for up to 19 patients.
- Must not have had previous treatment with folate receptor-targeting agents.
- Be 18 years or older.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have normal organ and bone marrow function based on specific blood tests.
- Have completed previous cancer treatments within a specified time before starting the study.
- Women of childbearing potential must use effective contraception during and after the study and have a negative pregnancy test before starting treatment.
- Be able to understand and sign a written informed consent document.
Exclusion Criteria
- Have had recent chemotherapy or radiotherapy within a specified time before starting the study.
- Be receiving other investigational treatments.
- Have stopped previous immunotherapy due to treatment-related side effects.
- Require folate supplements.
- Have active brain metastases or cancer in the brain lining.
- Have a history of severe allergic reactions to similar drugs.
- Have uncontrolled health conditions, such as heart disease or high blood pressure.
- Have active or chronic eye disorders requiring treatment.
- Have serious infections or a history of certain viral infections.
- Have received a live vaccine recently.
- Be using immunosuppressive medications, with some exceptions.
- Have active autoimmune diseases that could worsen with treatment.
- Have a history of lung inflammation requiring steroids.
- Be pregnant or breastfeeding.
- Have other cancers unless considered cured by a doctor.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| University of Massachusetts | 01605 | Worcester | Massachusetts |
| Northwell Cancer Institute | 11042 | Lake Success | New York |
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