A Phase III Study of Vemurafenib in Patients with Surgically Removed BRAF-Mutant Melanoma Who Have a High Risk of Recurrence

Protocol
12-166
Full Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Vemurafenib (RO5185426) Adjuvant Therapy in Patients with Surgically Resected, Cutaneous BRAF-Mutant Melanoma at High Risk for Recurrence
Phase
III
Purpose

Stage IIC and stage III melanoma can often be removed with surgery. However, there is a 50 to 85 percent chance of the cancer returning. In this study, researchers want to see if giving these patients the drug vemurafenib can reduce their risk of recurrence after the tumor has been surgically removed. Vemurafenib is currently approved for use in patients with inoperable metastatic melanoma, but its use to prevent recurrence in those with operable disease is considered investigational.

Vemurafenib works by targeting a mutated form of a protein called BRAF, which is found in many melanomas. Therefore, patients in this study will need to have melanoma that contains mutated BRAF.

Patients will be randomly assigned to receive either vemurafenib or a placebo. They should be aware that this study requires participants to visit Memorial Sloan-Kettering Cancer Center many times. Vemurafenib is a tablet that is taken orally (by mouth).

Eligibility

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

  • Patients must have stage IIC or III melanoma that has been surgically removed within 10 weeks of entering the study.
  • Patients’ tumors must have a mutated form of the BRAF protein. Patients do not need to know their mutation status before inquiring about enrollment. The tumor will be tested at Memorial Sloan-Kettering.
  • Patients may not have had prior chemotherapy, immunotherapy, or radiation therapy for melanoma.
  • Patients must have recovered from major surgery, with at least 4 weeks passing since the surgery and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and 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
Related Diseases