NCT07387198

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

Neoadjuvant Merkel Cell Carcinoma Therapy (Tx) With the PD-1 Inhibitor Cemiplimab - A Randomized, Double-blind, Placebo-controlled, Non-comparative Phase II Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Merkel Cell Carcinoma, Stage I
• Merkel Cell Carcinoma, Stage II
• Neoadjuvant Immunotherapy

Interventions

Type	Name	Description
DRUG	Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles	Patients will receive Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles
DRUG	Placebo NaCl 0.9% solution i.v. on day 1 of every 21 days cycle for 2 cycles.	Patients will receive NaCl 0.9% solution i.v. on day 1 of every 21 days cycle for 2 cycles.

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-12-31
• Completion: 2031-07-31
• First posted: 2026-02-04
• Last updated: 2026-04-17

Locations

14 sites across 1 country: Germany