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Anti-PD-1: Pembrolizumab 2mg/kg q3w

Phase 2, multi-center, First Line

o

Unresectable or M1 Merkel Carcinoma

o

ECOG 0-1

o

Up to 2 years or unacceptable toxicity

Primary Endpoint:

Objective Response

o

Tumor evaluation q12w 1st, q9w x 1Y, q12w in Y2

N= 26

III= 8% IV= 92%

RR 56% (4CR, 10 PR)

RR 10/16

RR 4/9

Nghiem P et al. NEJM 2016

MCPyV no impact on response to anti-PD-1