A Phase I Study of Dabrafenib and Ipilimumab with and without Trametinib for Advanced Melanoma

Protocol
12-285
Full Title
Phase 1 Study of the BRAF Inhibitor Dabrafenib +/- MEK Inhibitor Trametinib in Combination with Ipilimumab for V600E/K Mutation Positive Metastatic or Unresectable Melanoma
Phase
I
Purpose

Ipilimumab is a drug approved for the treatment of melanoma. It works by activating the immune system to attack the tumor. Dabrafenib is a newer drug designed to stop melanoma growth by turning off BRAF, a protein activated in some melanomas, while trametinib is a new drug designed to inhibit melanoma by blocking a protein called MEK.

The combination of these drugs has the potential to be effective against melanoma. The purpose of this study is to find the optimal dose combination of ipilimumab, dabrafenib, and trametinib in patients with metastatic or inoperable melanoma that contains V600E or V600K BRAF mutations. Patients will receive either ipilimumab/dabrafenib/trametinib or ipilimumab/dabrafenib.

Dabrafenib and trametinib are pills that are taken orally (by mouth), while ipilimumab is given intravenously (by vein).

Eligibility

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

  • Patients must have stage IIIC (inoperable) melanoma or stage IV (metastatic) melanoma that contains a V600E or V600K BRAF mutation.
  • Patients may have had up to one prior regimen of chemotherapy or immunotherapy for melanoma and must have recovered from any serious side effects before entering the study.
  • Patients may not have received prior treatment with BRAF or MEK inhibitors or ipilimumab.
  • 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. Margaret Callahan at 646-888-3579.

Disease(s)
Melanoma
Locations
Related Diseases