Actively Recruiting
Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients
Led by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Updated on 2026-03-11
34
Participants Needed
7
Research Sites
203 weeks
Total Duration
On this page
Sponsors
I
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead Sponsor
S
Skin Cancer Center Minden, Department of Dermatology, Johannes-Wesling-Klinikum Minden
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form available
- Patient 18 years or older at time of signing informed consent
- Histological diagnosis of basal cell carcinoma confirmed centrally
- Locally advanced basal cell carcinoma without distant metastases, not suitable for or refusing surgery or radiotherapy
- Expected survival of at least 6 months
- ECOG performance status of 0 or 1
- Adequate blood count, kidney, and liver function including neutrophils ≥ 1.5 x 10^9/L, platelets ≥ 75 x 10^9/L, hemoglobin ≥ 9 g/dL, bilirubin ≤ 1.5 times upper limit of normal (ULN), AST and ALT ≤ 3 times ULN, alkaline phosphatase ≤ 2.5 times ULN, and creatinine ≤ 2 times ULN or creatinine clearance ≥ 40 mL/min
- No severe comorbidities
- Resolution of acute treatment-related side effects to Grade 1 or less (except alopecia)
- Negative pregnancy test within 7 days before enrollment for females of childbearing potential
- Women of childbearing potential and men with partners of childbearing potential must agree to use effective contraception during treatment and for 6 months after last dose
You will not qualify if you...
- Prior systemic immunotherapy or targeted therapy such as hedgehog inhibitors
- Any anti-cancer therapy other than radiation within 30 days before starting Cemiplimab or planned during the study
- Significant autoimmune disease requiring systemic immunosuppression within 5 years, excluding certain controlled conditions
- Other cancers or blood diseases impairing immune response, including Gorlin-Goltz syndrome
- Use of immunosuppressive corticosteroids above 10 mg prednisone daily within 4 weeks before treatment, except specific allowed uses
- Known allergy or hypersensitivity to Cemiplimab or antibody treatments
- Active infections needing systemic therapy, including uncontrolled HIV, HBV, or HCV
- History of pneumonitis within last 3 years
- History of solid organ transplant (except corneal transplant with approval)
- Severe concurrent illnesses or conditions affecting safety or study evaluation
- Receipt of live vaccines within 30 days before treatment
- Pregnancy or breastfeeding
- Medical or psychological conditions preventing study completion or consent
- Substance abuse or social conditions interfering with participation
- Legal incapacity or limited legal capacity
- Participation in another clinical trial within 30 days before or during this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Helios Klinikum Erfurt
Erfurt, Germany
Actively Recruiting
2
Universitätsklinikum Erlangen
Erlangen, Germany
Actively Recruiting
3
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, Germany
Actively Recruiting
4
Universitätsklinikum Leipzig
Leipzig, Germany
Actively Recruiting
5
Johannes Wesling Klinikum
Minden, Germany
Actively Recruiting
6
Helios Klinikum Oberhausen
Oberhausen, Germany
Actively Recruiting
7
Universitätsklinikum Tübingen
Tübingen, Germany
Actively Recruiting
Research Team
R
Ralf Gutzmer, Prof. Dr. med.
CONTACT
M
Michelle Tez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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