Neoadjuvant Merkel Cell Carcinoma Therapy (Tx) With the PD-1 Inhibitor Cemiplimab

The study is a randomized, double blind, placebo-controlled, non-comparative phase II trial that investigates the efficacy of neoadjuvant anti-PD-1 antibody Cemiplimab treatment in patients with clinical stage I or II Merkel cell carcinoma who have have undergone primary tumour excision and are pending sentinel lymph node biopsy.

NCT Number	NCT07387198
Lead Sponsor	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Collaborators: Prof. Gutzmer, Skin Cancer Center Minden, Johannes-Wesling-Klinikum Minden, Germany, Universität Duisburg-Essen, Regeneron Pharmaceuticals
Conditions	Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Neoadjuvant Immunotherapy
Enrollment	135 participants
Start Date	2026-05-29
Primary Completion	2029-12-31 (estimated)
Study Completion	2031-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-22