Multidisciplinary Melanoma Program Facilitates Patient Care and Clinical Research

John H. Stewart, IV, MD

Wake Forest School of Medicine Associate Professor of Surgery Associate Dean for Clinical Research and Innovation Vice Chair for Academic Affairs, General Surgery Wake Forest Baptist Medical Center Comprehensive Cancer Center

The Malignant Melanoma Program at Wake Forest Baptist Health employs a multidisciplinary approach for the management of patients with all stages of this disease. The goals of the program are centered on unequivocal excellence in all areas of care for patients with malignant melanoma. The interdisciplinary team, led by John H. Stewart, IV, MD, includes radiology, medical and surgical oncology, dermatology, otolaryngology, physical/occupational therapy, and psychosocial support. The multidisciplinary team works to promote unfettered collaboration between all disciplines that manage malignant melanoma while providing innovative, evidence-based care for patients with this disease.

The hallmark of a multidisciplinary approach to melanoma is extensive communication with the patient and family. This approach is facilitated by nurse navigator Robin Petro. The nurse navigator begins to establish a relationship via a phone interview after a patient is referred to our program. During the phone interview, Petro conducts a risk assessment of each patient and family, and works to help integrate the family into the patient’s care and treatment. She also gathers data and information on the patient prior to the first visit so that the visit is customized to the medical and supportive care needs of the patient, including psychosocial support. The clinical nurse navigator allows portability across disciplines. The melanoma navigator’s clinical background provides physicians with a point person to communicate with as well. This model can save time and streamline communication across specialties. “We hear from patients and families that by the time the patient comes for the first visit they feel like we are extended family members,” said Petro. When patients arrive for their initial appointment, most of the services they will need are located in one site on the campus. This alleviates the stress of having to travel to different locations for care.

Translational Research in Malignant Melanoma

As an extension of our multidisciplinary collaboration, we promote active translational research aimed at treating advanced disease. The following are some of our ongoing clinical trials.

• A multicenter, double-blind, placebo-controlled, adaptive phase III trial of POL-103A polyvalent melanoma vaccine in post-resection melanoma patients with a high risk of recurrenceThe purpose of this study is to determine the efficacy and safety of the POL-103A polyvalent melanoma vaccine in patients with resected stage IIb, IIc, or III melanoma who have a high risk of recurrence. (NCT01546571)
• A phase III multicenter randomized trial of sentinel lymphadenectomy and complete lymph node dissection versus sentinel lymphadenectomy alone in cutaneous melanoma patients with molecular or histopathological evidence of metastases in the sentinel nodeThe purpose of this study is to determine if melanoma can be treated by sentinel node biopsy from a lymph or completion lymphadenectomy. Subjects will be randomly assigned to either (1) sentinel node dissection only, followed by frequent ultrasound monitoring of the surrounding lymph nodes or (2) sentinel node dissection, followed by complete lymph node dissection. (NCT00297895)
• A phase III randomized double blind study of dabrafenib (GSK2118436) in combination with trametinib (GSK1120212) versus two placebos in the adjuvant treatment of high-risk BRAF V600 mutation- positive melanoma after surgical resection (COMBI-AD)This is a two-arm, randomized, double-blind phase III study of dabrafenib in combination with trametinib versus two placebos in the adjuvant treatmentof melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk (stage IIIa [lymph node metastasis >1 mm], IIIb or IIIc), cutaneous melanoma will be screened for eligibility. Subjects will be randomized to receive either dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) combination therapy or two placebos for 12 months. (NCT01682083)
• A phase III randomized study of adjuvant ipilimumab anti-CTLA4 therapy versus high-dose interferon alfa-2b for resected high-risk melanoma This 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 removed by surgery. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known whether ipilimumab is more effective than interferon alfa-2b in treating patients with melanoma. (NCT01274338)
• The high-dose aldesleukin (IL-2) “SELECT” trial: a prospective tissue collection protocol to investigate predictive models of response to highdose IL-2 treatments in patients with advanced melanoma In order to learn more about melanoma therapy, we are collecting blood and tissue samples from people who will receive IL-2 treatment for their melanoma. IL-2 is approved by the FDA for the treatment of advanced melanoma and is a standard treatment for this disease. The purpose of this study is to determine which participants with melanoma have a better response to IL-2 and to identify markers that may predict response to IL-2 by collecting participant information (eg, cancer diagnosis and history and prior treatments for cancer), blood and tumor samples prior to treatment, and tumor measurements after treatment. (NCT01288963)

The Multidisciplinary Melanoma Program at Wake Forest has established a framework that facilitates optimal patient care and participation in clinical trials. We look forward to ushering in a new era of novel targeted therapies for melanoma as well as biological treatments for advanced disease. Furthermore, our team continues to strive to improve the quality of life for our patients and their family members.