Canadian Cancer Trials Group Bulletins

Trial Management Group


Trial Activation

MEC.5 (SWOG S1404) - A Phase III Randomized Trial Comparing High Dose Interferon to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma - was centrally activated on January 15, 2016.

MEC.5 is a phase III randomized trial targeting a patient population that is at a high and unacceptable risk of recurrence and death after standard surgical management. Patients will be assigned to Arm 1 High dose interferon alfa-2 b (HDI) or Arm 2 pembrolizumab (MK-3475). HDI is the current Health Canada-approved adjuvant treatment. The benefits of HDI remain modest and toxicity can be significant and prolonged. Adjuvant therapy for melanoma with HDI or pembrolizumab (MK-3475) is aimed at inducing an immune response that eradicates micrometastatic tumor deposits that may lead to a future melanoma relapse. This trial is designed to evaluate the recurrence-free survival (RFS) and overall survival (OS) of patients with resected Stage III and IV melanoma treated with HDI and pembrolizumab. RFS and OS will also be measured in the same population depending on PD-L1 status. The trial was activated in the US on October 15, 2015.

Patients enrolled in this study must have completely resected melanoma of cutaneous origin (stage IIIA (N2a), IIIB, IIIC, or Stage IV) or of unknown primary. Patients with melanoma of mucosal or other non-cutaneous origin are eligible except for those with melanoma of ocular origin. Patients with a history of brain metastases are ineligible. For all patients, all disease must have been resected with negative pathological margins and no clinical radiologic or pathological evidence of any incompletely resected melanoma. Patients must be registered with 98 day of the last surgery performed to render the patient free of disease. Accrual rate is expected to be 45 patients per month with a total of 1240 patients enrolled in less than 2.5 years.

The target sample size is 1240 patients.

Any Canadian participating member centre interested in joining this study, can contact Sarah Hunter, Study Coordinator at shunter@ctg.queensu.ca.

For more information, please visit the MEC.5 trial website ... https://www.ctg.queensu.ca/trials/melanoma/mec5/.