drugset / Trial / NCT07387198
Neoadjuvant Merkel Cell Carcinoma Therapy (Tx) With the PD-1 Inhibitor Cemiplimab
Phase 2
Recruiting
135 enrolled
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Prof. Gutzmer, Skin Cancer Center Minden, Johannes-Wesling-Klinikum Minden, Germany · collabRegeneron Pharmaceuticals · collabUniversität Duisburg-Essen · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2026-05-29
- Primary completion
- 2029-12-31
- Completion
- 2031-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cemiplimab | Monoclonal antibody | 350 mg | Intravenous |
Indications
No indication recorded.