The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma
Official Title: A Phase II Trial of Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Patients With Unresectable or Metastatic Melanoma
Study ID: NCT03149029
Brief Summary: This research study is studying a combination of drugs as a possible treatment for unresectable or metastatic melanoma. The drugs involved in this study are: * Pembrolizumab (Keytruda) * Trametinib (Mekinist) * Dabrafenib (Tafinlar)
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 approved pembrolizumab, dabrafenib, and trametinib for this specific disease but the combination of all three has not been approved. * This study is being conducted to document whether trametinib with or without dabrafenib taken for brief period of time prior to and with pembrolizumab works better than the investigators expect pembrolizumab to work in participants with unresectable and/or metastatic melanoma. All three of these drugs are FDA-approved for unresectable and/or metastatic melanoma; however, they are not FDA-approved for use all together. * Pembrolizumab is a type of antibody that inhibits the cancer cell growth. An antibody is a cell that attaches to other cells to fight off infection. * Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth. * Dabrafenib is also a cell inhibitor and works by stopping the cancer cell from duplicating.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Massachusetts general Hospital, Boston, Massachusetts, United States
Name: Ryan J Sullivan, MD
Affiliation: Massachusetts General Hospital
Role: PRINCIPAL_INVESTIGATOR