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

NCT06981325 | Recruiting Phase 2

• 1 other identifier: CEMI-first
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

BCC; Skin Cancer; Basal Cell Carcinoma; anti-PD-1 monoclonal antibody; HHI naïve; Cemiplimab

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (8)

• Objective Response Rate (ORR)

  42 months

• Progression Free Survival (PFS)

  42 months

• Duration of Response (DoR)

  42 months

• Overall Survival (OS)

  42 months

• Time to next systemic treatment (TTNsT)

  42 months

Other Outcomes (1)

• Determination of molecular biomarkers and their correlation with objective response rate (ORR)

  42 months

Study Arms (1)

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).

Drug: Cemiplimab

Interventions

Cemiplimab DRUG

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

Also known as: LIBTAYO

Cemiplimab - Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest: lead
• Translational Skin Cancer Research, University Duisburg-Essen: collaborator
• Regeneron Pharmaceuticals: collaborator
• Skin Cancer Center Minden, Department of Dermatology, Johannes-Wesling-Klinikum Minden: collaborator

Study Sites (7)

Helios Klinikum Erfurt

Erfurt, Germany

RECRUITING

Universitätsklinikum Erlangen

Erlangen, Germany

RECRUITING

Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, Germany

RECRUITING

Universitätsklinikum Leipzig

Leipzig, Germany

RECRUITING

Johannes Wesling Klinikum

Minden, Germany

RECRUITING

Helios Klinikum Oberhausen

Oberhausen, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, Germany

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell; Skin Neoplasms

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Salah-Eddin Al-Batran, Prof. Dr. med.

  Institut für Klinische Krebsforschung IKF GmbH

  STUDY DIRECTOR

• Ralf Gutzmer, Prof. Dr. med.

  Johannes Wesling Klinikum Minden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ralf Gutzmer, Prof. Dr. med.

CONTACT

+49 571/ 790 4501; Ralf.Gutzmer@Muehlenkreiskliniken.de

Michelle Tez

CONTACT

+4969 / 5899 787 65; tez.michelle@ikf-khnw.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: May 20, 2025
• Study Start: August 7, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)