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

• Completely resected cutaneous or mucosal melanoma (or unknown primary)

• Stage IIIB, IIIC, or IV (M1a, M1b, or M1c allowed). IIIA allowed only if N2a

• May be eligible either at initial presentation or following resection of recurrence

• Must have undergone wide excision of primary lesion (if present)

• Full lymphadenectomy required for all patients with positive sentinel nodes

• Must be registered within 98 days of final surgery for melanoma

• Must have 5 unstained slides available from original or current tumor

• Must be disease free on scans within 42 days of therapy

• ECOG PS 0-1

• No prior systemic therapy for melanoma

• Prior radiation is allowed

• No brain mets (or history of brain mets)

• No autoimmune disease

• No HBV or HCV

• HIV allowed if CD4 counts >350, viral load <25,000

Primary- OS, DFS: Secondary- QOLD, efficacy by BRAF and PD-L1 status, post-relapse threapy, long term survival

Pembrolizumab 200mg IV q3 weeks x 1 year; Ipilimumab 10mg/kg IV q3 weeks x4 doses then q12 weeks x3 years; Interferon per prescribing information