RecruitingPhase 2NCT07387198

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


Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrollment

135 participants

Start Date

May 29, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles and a drug called Placebo NaCl 0.9% solution i.v. on day 1 of every 21 days cycle for 2 cycles. for people with merkel cell carcinoma, stage i, merkel cell carcinoma, stage ii, and other related conditions. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCemiplimab 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

DRUGPlacebo 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.


Locations(14)

Nationales Centrum für Tumorerkrankungen

Heidelberg, Baden-Wurttemberg, Germany

Universitätsklinikum Mannheim

Mannheim, Baden-Wurttemberg, Germany

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany

Universitätsklinikum Regensburg

Regensburg, Bavaria, Germany

Universitätsklinikum Würzburg

Würzburg, Bavaria, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, Germany

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, Germany

Klinikum Bielefeld

Bielefeld, North Rhine-Westphalia, Germany

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Johannes Wesling Klinikum Minden

Minden, North Rhine-Westphalia, Germany

Universitätsmedizin Mainz

Mainz, Rhineland-Palatinate, Germany

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

Helios Klinikum Erfurt

Erfurt, Thuringia, Germany

View Full Details on ClinicalTrials.gov

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NCT07387198


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