Actively Recruiting
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
Led by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Updated on 2026-03-11
34
Participants Needed
7
Research Sites
39 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
Researchers are evaluating the effectiveness and safety of Cemiplimab as a first-line treatment for patients with locally advanced basal cell carcinoma (BCC) who have not previously received hedgehog inhibitor therapy. This phase II, open-label, single-arm trial aims to measure the objective response rate after six months of treatment in this patient group. Patients with advanced BCC who cannot undergo surgery or radiotherapy are included to explore new treatment options. Participants will receive Cemiplimab intravenously at a dose of 350 mg on day 1 of every 21-day cycle for up to 12 months or a maximum of 17 cycles. Treatment may stop earlier if intolerable side effects or disease progression occurs. Tumor samples will be collected for research to identify potential biomarkers that may relate to the drug's effectiveness. The study also includes follow-up visits every 12 weeks to monitor response and safety until death or for up to 12 months after the last dose. Throughout the study, patients will have regular assessments including tumor response evaluations every 12 weeks during treatment and follow-up. Researchers will monitor safety by tracking adverse events and laboratory parameters. The main outcome measured is the objective response rate at six months, with additional measures such as progression-free survival and overall survival tracked for up to 42 months. Participants are followed closely to understand both the benefits and risks of Cemiplimab in this setting.
CONDITIONS
Brief 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
- Age 18 years or older at time of consent
- Histologically confirmed basal cell carcinoma
- Locally advanced disease without distant metastases, not suitable for surgery or radiotherapy, or surgery/radiotherapy refused
- Expected survival of at least 6 months
- ECOG performance status of 0 or 1
- Adequate blood count, kidney, and liver function within specified limits
- No severe comorbidities
- Recovery from any prior treatment-related adverse events to Grade 1 or less except alopecia
- Negative pregnancy test for women of childbearing potential within 7 days before enrollment
- Use of effective contraception during treatment and for 6 months after last dose for sexually active women and men with partners of childbearing potential
You will not qualify if you...
- Previous systemic immunotherapy or hedgehog inhibitor treatment
- Other anti-cancer therapies within 30 days before starting Cemiplimab or planned during study
- Significant autoimmune diseases requiring systemic immunosuppression within 5 years, except certain conditions
- Other cancers or hematologic diseases impacting immune response
- High-dose corticosteroid use within 4 weeks before treatment
- Allergic reactions to Cemiplimab or similar antibody treatments
- Active infections requiring systemic therapy or uncontrolled HIV, HBV, HCV infections
- History of pneumonitis within 3 years
- History of solid organ transplant (except corneal transplant with approval)
- Severe concurrent medical or psychological conditions affecting study participation
- Live vaccinations within 30 days before first dose
- Pregnancy or breastfeeding
- Conditions preventing informed consent or study completion
- Substance abuse or social conditions interfering with participation
- Legal incapacity or limited 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive Cemiplimab 350 mg intravenously on day 1 of each 21-day cycle for up to 12 months or until intolerable toxicity or disease progression, whichever occurs first.
Approximately 17 treatment cycles with assessments every 12 weeks
Duration - Up to 12 months after treatment ends
Participants are followed for safety and treatment response for up to 12 months after the last dose of Cemiplimab or until death.
Assessments every 12 weeks during follow-up
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.
M
Michelle Tez
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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