Basal Cell Carcinoma (BCC)Phase 2CEMI-firstNCT06981325
Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients
A Phase 2 study testing Cemiplimab in people with Basal Cell Carcinoma (BCC) and First Line Treatment, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 8 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma (BCC), First Line Treatment
- What is being tested?
- Cemiplimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 8 sitesGermany
- Study dates
- 7 Aug 2025to Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form available
- Patient* 18 years or older at time of signing informed consent form
- Centrally confirmed histological diagnosis of BCC
- NOTE: Tumor tissue to be sent to Central Pathology during screening procedure:
- Formalin-fixed, parrafin-embedded (FFPE) tumor specimen in a paraffin block (preferred) OR
- approximately 10 sections (5µm thickness) on uncoated slides and 10 sections (5µm thickness) on Superfrost Ultra slides containing unstained, freshly cut, serial sections to be submitted along with associated pathology report (please refer to section 11.1.1 for details)
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- Locally advanced stage without distant metastases, not amenable for surgery or radiotherapy or surgery/radiotherapy contraindicated or refused by patient (as evidenced in source data)
- Expected survival of at least 6 months
- ECOG performance status 0 or 1
- Adequate laboratory parameters particularly for the blood count, renal and liver function parameters.
- Absolute number of neutrophils ≥ 1.5 x 109/L
- Platelets ≥ 75 x 109/L
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), (patients with Gilbert´s Disease and total bilirubin up to 3x ULN may be eligible after approval from trial's medical expert)
- AST (SGOT) and ALT (SGPT) ≤ 3x ULN
- AP ≤ 2.5x ULN
- Serum creatinine ≤ 2x ULN or creatinine clearance ≥ 40 mL/min
- Absence of other severe comorbidities
- Resolution of any acute, clinically significant treatment-related adverse events from prior therapy/procedure to Grade ≤ 1 prior to study entry, with the exception of alopecia.
- Negative serum pregnancy test done less than or equal to 7 days prior to enrollment, for females of childbearing potential only.
- Sexually active women of childbearing potential (WOCBP) and men with WOCBP partners must be prepared to use suitable contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of Cemiplimab
- There are no data that indicate special gender distribution. Therefore, patients will be enrolled in the study gender-independently
Who cannot join
- Pretreatment with systemic immunotherapy (such as PD-1/PD-L1 or CTL4) or targeted therapy (such as hedgehog inhibitor) NOTE: Prior treatment with imiquimod or other topical or intralesional immune modulators will not be exclusionary
- Any other non-radiation anti-cancer therapy (e.g. imiquimod, photodynamic therapy; neither investigational nor standard of care) within 30 days (from date of last administration) of initial Cemiplimab administration or if planned during the study duration
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required systemic immunosuppressive therapy, excluding: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism requiring only hormone replacement, or psoriasis that does not require systemic treatment
- Other neoplasia, in particular hematologic diseases that might impair immune response, such as chronic lymphocytic leukemia, myelodysplastic or myeloproliferative disease and patients with Gorlin-Goltz syndrom
- Immunosuppressive corticosteroid doses (> 10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of Cemiplimab NOTE: Patients who require brief courses of steroids (e.g., as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are eligible for participation. Furthermore, patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or replacement in case of adrenal or hypophysis insufficiency are eligible for participation.
- Known allergic/hypersensitive reaction to the study drug and any of its excipients or history of documented allergic/hypersensitive reactions to antibody treatments
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- Active infection requiring systemic therapy, including uncontrolled HIV, HBV and HCV infection or diagnosis of immunodeficiency.
- NOTE: Patients are eligible if:
- Patients have controlled HIV infection with CD4 counts is > 350 cells/µL and viral load is undectable [HIV RNA PCR]
- Patients positive for HBV surface antigen have controlled HBV infection receiving anti-viral therapy and with undectable serum viral load [HBV DNA PCR]. Patients must remain on anti-viral therapy for at least 6 months after last dose of Cemiplimab
- Patients positive for HCV antibody have controlled HCV infection with undectable viral load [HCV RNA PCR]
- History of pneumonitis within the last 3 years
- Patients with history of solid organ transplant (patients with prior corneal transplants may be allowed to enroll after discussion with and approval from the Lead Investigator)
- Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Receipt of live vaccines (including attenuated) within 30 days of first administration of Cemiplimab
- Pregnancy or lactation period.
- Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Legal incapacity or limited legal capacity.
- On-treatment participation in another clinical trial in the period 30 days prior to start of the study treatment and during the study
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Germany8 sites, 8 recruiting
- Recruiting
Helios Klinikum Erfurt
Erfurt
- Recruiting
Universitätsklinikum Erlangen
Erlangen
- Recruiting
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg
- Recruiting
Universitätsklinikum Leipzig
Leipzig
- Recruiting
Johannes Wesling Klinikum
Minden
- Recruiting
Helios Klinikum Oberhausen
Oberhausen
- Recruiting
Universitätsklinikum Regensburg
Regensburg
- Recruiting
Universitätsklinikum Tübingen
Tübingen
About this study
Official title: 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
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).
Read the detailed description
The present study is an explorative, investigator-initatied, single-arm, multicentre phase II trial. Patients with locally advanced BCC without pretreatment with hedgehog inhibitors such as vismodegib and sonidegib will receive Cemiplimab (350 mg, i.v.) at day 1 of each 21 days cycle for up to 12 months (max. 17 cycles) or until intolerable toxicity or disease progression, whatever occurs first. All patients will be followed up until death or for up to 12 months after last patient last application of Cemiplimab. The treatment response will be assessed every 12 weeks (± 7 days) during the treatment and the follow up phase. In addition, tumor samples will be collected and used for translational research providing the basis for the establishment of potential biomarkers correlating with the efficacy of Cemiplimab. The primary objective of this study is to evaluate the efficacy of Cemiplimab when applied as first-line treatment in advanced, HHI naïve BCC measured by objective response rate (ORR) after 6 months of treatment. Secondary objective is to evaluate the safety and tolerability of Cemiplimab as first-line treatment in advanced BCC.
- Conditions
- Basal Cell Carcinoma (BCC), First Line Treatment
- Being tested
- Cemiplimab
- Keywords
- BCC, Skin Cancer, Basal Cell Carcinoma, anti-PD-1 monoclonal antibody, HHI naïve, Cemiplimab
- Medical subject headings
- Carcinoma, Basal Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Also called LIBTAYO
Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for up to 12 months (max. 17 cycles).
| Study group | Role | What they receive |
|---|---|---|
| Cemiplimab - Single Arm | Experimental | Single Arm with Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for up to 12 months (max. 17 cycles). Receives: Drug: Cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) at six months
ORR@6months, defined as the rate of patients assessed with complete or partial response (CR or PR) according to ERIVANCE-like criteria as best overall response, relative to the total number of patients as evaluated 6 months after treatment allocation.
Measured: 24 months
Secondary outcomes (8)
Objective Response Rate (ORR)
rate of patients assessed with complete or partial response (CR or PR) as best overall response, relative to the total number of patients.
Measured: 42 months
Progression Free Survival (PFS)
time from date of allocation to treatment to the date of the first objectively documented tumor progression, as determined by investigators, or death due to any cause.
Measured: 42 months
Duration of Response (DoR)
length of time from initial response (CR/PR) to first objectively documented progression or death.
Measured: 42 months
Overall Survival (OS)
time from date of allocation to treatment until the date of death from any cause
Measured: 42 months
Time to next systemic treatment (TTNsT)
time from date of allocation to treatment to initiation of the next line of systemic therapy
Measured: 42 months
Safety (AEs and SAEs)
Incidence of adverse events and serious adverse events
Measured: 42 months
AE severity
Severity of adverse events by CTCAE v5.0 grade
Measured: 42 months
Safety (AEs)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start7 Aug 2025
- Primary completionOct 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell Carcinoma (BCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical trial with a single arm, all eligible patients will receive Cemiplimab 350 mg (i.v.) on day 1 of every 21 cycle for up to 12 months (max. 17 cycles) or until intolerable toxicity or disease progression, whatever occurs first.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Sponsor type
- University, hospital or other
- Collaborators
- Skin Cancer Center Minden, Department of Dermatology, Johannes-Wesling-Klinikum Minden, Universität Duisburg-Essen, Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Salah-Eddin Al-Batran, Prof. Dr. med., Study director, Institut für Klinische Krebsforschung IKF GmbHRalf Gutzmer, Prof. Dr. med., Principal investigator, Johannes Wesling Klinikum Minden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981325
- Sponsor's protocol ID
- CEMI-first
- Acronym
- CEMI-first
- Status last verified
- Nov 2026
- First submitted
- 6 Mar 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06981325
- Acronym / sponsor ID
- CEMI-first / CEMI-first
- Conditions
- Basal Cell Carcinoma (BCC), First Line Treatment
- Keywords
- BCC, Skin Cancer, Basal Cell Carcinoma, anti-PD-1 monoclonal antibody, HHI naïve, Cemiplimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestUniversity, hospital or other
- Collaborators
- Skin Cancer Center Minden, Department of Dermatology, Johannes-Wesling-Klinikum Minden, Universität Duisburg-Essen, Regeneron Pharmaceuticals
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The present study is an explorative, investigator-initatied, single-arm, multicentre phase II trial. Patients with locally advanced BCC without pretreatment with hedgehog inhibitors such as vismodegib and sonidegib will receive Cemiplimab (350 mg, i.v.) at day 1 of each 21 days cycle for up to 12 months (max. 17 cycles) or until intolerable toxicity or disease progression, whatever occurs first. All patients will be followed up until death or for up to 12 months after last patient last application of Cemiplimab. The treatment response will be assessed every 12 weeks (± 7 days) during the treatment and the follow up phase. In addition, tumor samples will be collected and used for translational research providing the basis for the establishment of potential biomarkers correlating with the efficacy of Cemiplimab. The primary objective of this study is to evaluate the efficacy of Cemiplimab when applied as first-line treatment in advanced, HHI naïve BCC measured by objective response rate (ORR) after 6 months of treatment. Secondary objective is to evaluate the safety and tolerability of Cemiplimab as first-line treatment in advanced BCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical trial with a single arm, all eligible patients will receive Cemiplimab 350 mg (i.v.) on day 1 of every 21 cycle for up to 12 months (max. 17 cycles) or until intolerable toxicity or disease progression, whatever occurs first.
| Arm | Type | Receives |
|---|---|---|
| Cemiplimab - Single Arm | Experimental | Drug: CemiplimabSingle Arm with Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for up to 12 months (max. 17 cycles). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Signed informed consent form available
- Patient* 18 years or older at time of signing informed consent form
- Centrally confirmed histological diagnosis of BCC
- Locally advanced stage without distant metastases, not amenable for surgery or radiotherapy or surgery/radiotherapy contraindicated or refused by patient (as evidenced in source data)
- Expected survival of at least 6 months
Key exclusion criteria (20 listed)
- Pretreatment with systemic immunotherapy (such as PD-1/PD-L1 or CTL4) or targeted therapy (such as hedgehog inhibitor) NOTE: Prior treatment with imiquimod or other topical or intralesional immune modulators will not be exclusionary
- Any other non-radiation anti-cancer therapy (e.g. imiquimod, photodynamic therapy; neither investigational nor standard of care) within 30 days (from date of last administration) of initial Cemiplimab administration or if planned during the study duration
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required systemic immunosuppressive therapy, excluding: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism requiring only hormone replacement, or psoriasis that does not require systemic treatment
- Other neoplasia, in particular hematologic diseases that might impair immune response, such as chronic lymphocytic leukemia, myelodysplastic or myeloproliferative disease and patients with Gorlin-Goltz syndrom
- Immunosuppressive corticosteroid doses (> 10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of Cemiplimab NOTE: Patients who require brief courses of steroids (e.g., as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are eligible for participation. Furthermore, patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or replacement in case of adrenal or hypophysis insufficiency are eligible for participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CemiplimabAlso: LIBTAYOCemiplimab 350 mg i.v. on day 1 of every 21 days cycle for up to 12 months (max. 17 cycles). | Drug | Cemiplimab - Single Arm |
Primary outcome
Objective Response Rate (ORR) at six months
Time frame: 24 months
ORR@6months, defined as the rate of patients assessed with complete or partial response (CR or PR) according to ERIVANCE-like criteria as best overall response, relative to the total number of patients as evaluated 6 months after treatment allocation.
8 secondary outcomes
Objective Response Rate (ORR)
Time frame: 42 months
Progression Free Survival (PFS)
Time frame: 42 months
Duration of Response (DoR)
Time frame: 42 months
Overall Survival (OS)
Time frame: 42 months
Time to next systemic treatment (TTNsT)
Time frame: 42 months
Safety (AEs and SAEs)
Time frame: 42 months
AE severity
Time frame: 42 months
Safety (AEs)
Time frame: 42 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No. No IPD will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salah-Eddin Al-Batran, Prof. Dr. med. study director
Institut für Klinische Krebsforschung IKF GmbH
Ralf Gutzmer, Prof. Dr. med. principal investigator
Johannes Wesling Klinikum Minden
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cemiplimab in people with Basal Cell Carcinoma (BCC) and First Line Treatment, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 8 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ralf Gutzmer, Prof. Dr. med. (+49 571/ 790 4501, Ralf.Gutzmer@Muehlenkreiskliniken.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) at six months (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.