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Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients

NCT06981325 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-03-11

No results posted yet for this study

Summary

The study is an open-label, singel arm, prospective, multicenter phase II trial evaluating the efficacy and safety of Cemiplimab when applied as first-line therapy in patients with locally advanced basal cell carcinoma (BCC), which were not pretreated with hedgehog inhibitors (HHI).

Conditions

  • Basal Cell Carcinoma (BCC)
  • First Line Treatment

Interventions

DRUG

Cemiplimab

Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for up to 12 months (max. 17 cycles).

Sponsors & Collaborators

  • Skin Cancer Center Minden, Department of Dermatology, Johannes-Wesling-Klinikum Minden

    collaborator UNKNOWN

  • Translational Skin Cancer Research, University Duisburg-Essen

    collaborator UNKNOWN

  • Regeneron Pharmaceuticals

    collaborator INDUSTRY

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    lead OTHER

Principal Investigators

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

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-07
Primary Completion
2028-10-31
Completion
2029-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
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 NCT06981325 on ClinicalTrials.gov