A Phase III Randomized Trial Comparing Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma.
Sapna P. Patel
Treatment Location: N/A
Primary Objectives To compare overall survival (OS) of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b versus MK-3475 (pembrolizumab) Among patients who are PD-L1 positive, to compare OS of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b versus MK- 3475 (pembrolizumab). To compare relapse-free survival (RFS) of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b to MK-3475 (pembrolizumab). Among patients who are PD-L1 positive, to compare RFS of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b to MK-3475 (pembrolizumab). Secondary Objectives To estimate OS and RFS for patients who are PD-L1 negative or PD-L1 indeterminate in this population. To compare OS and RFS of patients between the two regimens within PD-L1 positive and negative subgroups and to look at the interaction between PD-L1 (positive versus negative) and treatment arm. To assess the safety and tolerability of the two regimens. Additional Objectives To bank tissue and whole blood in anticipation of future correlative studies in patients with high risk resected melanoma treated with HDI and MK-3475 (pembrolizumab). To evaluate PD-L1expression through immunohistochemistry assay. To evaluate the effect of treatment-related side effects that may have an impact on the health-related domains of quality of life (QOL) using the FACT-BRM, EQ-5D-3L and FACIT-D between patients treated with physician/patient choice of either high-dose interferon alfa-2b and MK- 3475 (pembrolizumab). Pharmacokinetic (PK) and anti-drug antibody (ADA) testing will be performed on all patients receiving MK-3475 (pembrolizumab). These analyses will evaluate: exposure-response analyses for activity and efficacy, potential pharmacodynamic biomarkers, and the safety of MK-3475 (pembrolizumab).
IRB Review and Approval Date: 12/14/2015
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
Sapna P. Patel
Melanoma Medical Oncology
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