RecruitingPhase 2NCT06981325

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

Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (CEMI-first) - An Open Label, Single Arm, Prospective Phase II Trial of the DeCOG Network


Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrollment

34 participants

Start Date

Aug 7, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing cemiplimab — an immunotherapy drug that helps the immune system fight cancer — as a first-line treatment for people with advanced basal cell carcinoma (BCC), a type of skin cancer. It is for patients whose cancer has spread or cannot be treated with surgery or radiation. **You may be eligible if...** - You are 18 or older with a biopsy-confirmed diagnosis of basal cell carcinoma - Your cancer is locally advanced (spread nearby but not to distant organs) and cannot be surgically removed or treated with radiation - You are in good general health with adequate blood counts and organ function - Your expected survival is at least 6 months **You may NOT be eligible if...** - You have already received prior immunotherapy - You have an active autoimmune disease requiring immune-suppressing medications - You have uncontrolled infections, significant heart disease, or active brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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

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


Locations(7)

Helios Klinikum Erfurt

Erfurt, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, Germany

Universitätsklinikum Leipzig

Leipzig, Germany

Johannes Wesling Klinikum

Minden, Germany

Helios Klinikum Oberhausen

Oberhausen, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

View Full Details on ClinicalTrials.gov

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NCT06981325


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