Study on Abbreviated MAPK Targeted Therapy Plus Pembrolizumab for Melanoma
Sponsor: Massachusetts General Hospital
ClinicalTrials ID:NCT03149029
This clinical trial is exploring a new combination of drugs to treat melanoma that cannot be surgically removed or has spread to other parts of the body. The study involves the drugs Pembrolizumab, Trametinib, and Dabrafenib.
Patient Parameters
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Program Overview
The purpose of this study is to test a combination of three drugs—Pembrolizumab, Trametinib, and Dabrafenib—to see if they can effectively treat melanoma that is either metastatic (spread to other parts of the body) or cannot be removed by surgery. While each of these drugs is approved for treating melanoma, their combined use is still being studied. Pembrolizumab helps the immune system fight cancer, while Trametinib and Dabrafenib work by blocking signals that help cancer cells grow.
Description
This is a Phase II clinical trial, which means it is focused on testing the safety and effectiveness of the drug combination. Although Pembrolizumab, Dabrafenib, and Trametinib are approved for treating melanoma, their combined use is not yet approved. The study aims to find out if taking Trametinib, with or without Dabrafenib, for a short time before and with Pembrolizumab works better than Pembrolizumab alone in treating melanoma.
Pembrolizumab is an antibody that helps stop cancer cells from growing. Trametinib and Dabrafenib are inhibitors that block signals in cancer cells, preventing them from multiplying. The study will help determine if this combination is more effective than current treatments.
Eligibility Criteria
Inclusion Criteria
- Must have melanoma that is either metastatic or cannot be surgically removed.
- Must have at least one tumor that can be measured by scans.
- May have had certain previous treatments like ipilimumab or high-dose IL-2, but not BRAF or MEK inhibitors.
- Must be 18 years or older.
- Must have a good performance status and life expectancy of more than three months.
- Must have normal organ and blood function based on specific tests.
- Must know their BRAFV600 mutation status.
- Must be willing to undergo tumor biopsies.
- Women of childbearing potential must use two forms of birth control or be surgically sterile.
- Must be able to understand and sign a consent form.
Exclusion Criteria
- Cannot have had chemotherapy or radiation within two weeks before starting the study.
- Cannot have been treated with BRAF or MEK inhibitors for metastatic or unresectable melanoma.
- Cannot have symptomatic brain metastases.
- Cannot have had a monoclonal antibody treatment within four weeks before starting the study.
- Cannot be on other cancer treatments.
- Cannot have an immune deficiency or be on immunosuppressive therapy.
- Cannot be pregnant or breastfeeding.
- Cannot be HIV-positive and on antiretroviral therapy.
- Cannot have had major surgery within two weeks before the study.
- Cannot have active tuberculosis.
- Cannot have allergies to Pembrolizumab.
- Cannot have active autoimmune diseases requiring treatment in the past two years.
- Cannot have a history of lung inflammation requiring steroids.
- Cannot have certain eye conditions or uncontrolled illnesses.
- Cannot have had another cancer within the past three years, except for certain skin or cervical cancers.
- Cannot have active Hepatitis B or C.
- Cannot have received a live vaccine within 30 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Beth Israel Deaconess Medical Center | 02115 | Boston | Massachusetts |
| Massachusetts general Hospital | 02115 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
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