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Anti-PD-L1: Avelumab
Patients: key eligibility criteria
•
Histologically confirmed stage IV MCC
– Disease progression following ≥1 prior
line of chemotherapy in the
metastatic setting
•
Immune-competent status
•
Unselected for PD-L1 expression or MCPyV
status
•
ECOG PS 0-1 and adequate end-organ
function
Treatment
Avelumab
10 mg/kg IV Q2W
until confirmed PD,*
or unacceptable
Part
Key
assessments
A
2L+
Primary
endpoint: BOR
by RECIST v1.1
per IRC
B
1L
Primary
endpoint:
Response
durability
Phase 2, prospective, open label, international, multicenter trial
•
Part A cohort mMCC 2L+ N=88
•
Part B cohort mMCC 1L N=112
Kaufman et al. Lancet Oncology 2016