MedTrace Logo

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

NCT07387198 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-04-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Prof. Gutzmer, Skin Cancer Center Minden, Johannes-Wesling-Klinikum Minden, Germany

    collaborator UNKNOWN

  • Prof. Becker, Translational Skin Cancer Research University Duisburg-Essen, Germany

    collaborator UNKNOWN

  • Regeneron Pharmaceuticals

    collaborator INDUSTRY

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Salah Al-Batran, Prof. Dr. · Institut für Klinische Krebsforschung IKF GmbH

  • Ralf Gutzmer, Prof. Dr. med. · Johannes Wesling Klinikum Minden

  • Juergen C. Becker, Prof. Dr. Dr. · Translational Skin Cancer Research University Duisburg-Essen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-12-31
Completion
2031-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07387198 on ClinicalTrials.gov