Dana-Farber / Brigham and Women's Cancer Center

New Melanoma Clinical Trials Build on Recent Successes

Stephen Hodi, MD

Led by Director F. Stephen Hodi, MD, medical oncologists in the Center for Melanoma Oncology offer an average of 12 to 14 clinical trials at a given time and have made recent discoveries that have changed the standard-of-care for patients with advanced melanoma.

Medical oncologists in the Center for Melanoma Oncology at Dana-Farber/Brigham and Women’s Cancer Center are pioneering new medical approaches for the treatment of all forms of melanoma.

Groundbreaking Discoveries

The team led the Phase III trial of ipilimumab, the first drug to demonstrate a survival benefit for patients with metastatic melanoma and the first drug to be FDA approved for melanoma in 13 years (N Engl J Med. 2010 Aug 19;363(8):711-23.).  Approved in March 2011, ipilimumab is a CTLA-4 inhibitor and part of new class of drugs that is being evaluated in the treatment of other cancers as well.

"Clinical trials are a cornerstone of our Center," said Dr. Hodi. "We are building on results we have seen with ipilimumab, combining this drug with other agents and evaluating other new immunotherapies and targeted therapies to enhance treatment response."

Next-Generation Treatment Approaches

Today, Center specialists are spearheading the investigation of the next generation of treatments for melanoma. Select current clinical trials offered at the Center incorporate numerous early-phase studies, including:

Combination Therapies

  • Randomized Phase II Trial of Vemurafenib (PLX4032/RG7204) With or Without Bevacizumab in Patients With Stage IV BRAFV600 Mutant Melanoma  –  Dr. Hodi is the Co-Principal Investigator of this national trial designed to determine the effectiveness of using vemurafenib, a BRAF inhibitor, and bevacizumab, a VEGF inhibitor, together relative to vemurafenib alone;
  • Phase I Trial of Bevacizumab Plus Ipilimumab in Patients With Unresectable Stage III or IV Melanoma  –  Dr. Hodi is leading this regional trial, which is examining the safety, tolerability and maximum tolerated dosing for the combination of bevacizumab plus ipilimumab in patients with unresectable stage III or stage IV melanoma.

Adjuvant Therapy

  • Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon Alpha-2b for Resected High-Risk Melanoma – This national Phase III clinical trial is studying ipilimumab or high-dose interferon alfa-2b in treating patients with high-risk stage III or stage IV melanoma that has been surgically resected. Dr. Hodi is the Co-Principal Investigator of this trial.

Acral and Mucosal Melanoma Trials

  • Phase II Study of Nilotinib (AMN107) In TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral or Chronically Sun Damaged Melanoma  – This regional study, led by Dr. Hodi, is evaluating the effectiveness of nilotinib in treating advanced acral, mucosal, or melanoma arising from sun-damaged skin which has not responded to treatment with another Tyrosine Kinase Inhibitor (including but not limited to imatinib mesylate, sunitinib, or dasatinib treatment) or was not tolerated;
  • Phase II Study of SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma – This regional trial, led by Dr. Hodi, is evaluating the efficacy of SU011248, a protein-tyrosine kinase inhibitor and c-kit inhibitor, in treating advanced acral lentiginous and mucosal melanoma.

For more information on clinical trials in the Center for Melanoma Oncology, please contact Research Nurse Kristina Kelley, RN, at (617) 582-8687 or Research Nurse Amanda Livengood, RN, at (617) 632-5789.

The team sees patients in weekly multidisciplinary clinics, which facilitate the development of multimodality treatment plans.  These clinics also provide multidisciplinary management of dermatologic side effects of treatments and enable screening of patients for new melanomas or recurrence of primary melanomas, as well as treatment other non-melanoma skin cancers. Common in patients with melanoma, non-melanoma skin cancers can arise as a result of medical therapies used for melanoma.

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