A Phase II Study of Dabrafenib After Surgery in Patients with BRAF V600 Mutation-Positive Stage IIIC Melanoma

Protocol
12-124
Full Title
A Phase 2 Trial of Adjuvant Dabrafenib (GSK2118436) in Patients with Surgically Resected AJCC Stage IIIC Melanoma Characterized by a BRAFV600E/K Mutation
Phase
II
Purpose

Dabrafenib is a new drug that works by inhibiting the activity of BRAF, a protein which, when mutated, drives the growth of many melanomas. Prior research has shown that dabrafenib is more effective than standard chemotherapy for slowing the growth of inoperable stage III or IV melanoma. It is a pill that it taken orally (by mouth).

In this study, researchers are evaluating the safety and effectiveness of dabrafenib in patients with stage IIIC melanoma that was able to be surgically removed and contains a BRAF V600 mutation. Even after surgery, people with stage IIIC melanoma have a high risk of disease recurrence, and doctors are hoping that dabrafenib can reduce this risk.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage IIIC melanoma that was surgically removed within 6 weeks of entering the study.
  • Patients’ melanoma must contain a BRAF V600 mutation. Patients do not need to know this information before inquiring about enrollment; the tumor will be tested at Memorial Sloan-Kettering.
  • Patients may not be receiving concurrent radiation therapy, chemotherapy, or immunotherapy.
  • Patients must be fully active and able to carry on all pre-disease activities without restriction.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Paul Chapman at 646-888-4162.

Disease(s)
Melanoma
Locations
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