Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03149029
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab is a type of antibody that inhibits the cancer cell growth
  • Dabrafenib — DRUG
    Dabrafenib is also a cell inhibitor and works by stopping the cancer cell from duplicating
  • Trametinib — DRUG
    Trametinib is a cell inhibitor that binds to the cancer cells to inhibit the cancer cells' signals to decrease cell growth

Study Details

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)

Key Dates

Start date
Nov 27, 2017
Status verified
Mar 2026
Primary completion
Dec 31, 2021
Completion
Dec 31, 2026

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BRAFV600 mutant
    * Pembrolizumab administered intravenously every three weeks * Dabrafenib taken every twelve hours orally * Trametinib taken every twelve hours orally
  • Experimental: BRAFV600 wild type
    * Pembrolizumab administered intravenously every three weeks * Trametinib taken every twelve hours orally

Primary Outcome Measure

The Rate of Clinical Benefit [ Time Frame: 6 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts general HospitalBostonMassachusetts02115-

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