Authorised Therapeutic exploratory (Phase II) basal cell carcinoma

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

EU CTIS ID: 2024-517647-31-00

What this study is testing

The assessment of 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.

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Signed informed consent form available.
10. Negative serum pregnancy test done less than or equal to 7 days prior to enrollment, for females of childbearing potential only.
11. 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
2. Patient* 18 years or older at time of signing informed consent form. * There are no data that indicate special gender distribution. *Therefore, patients will be enrolled in the study gender-independently
3. 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)
4. 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)

You likely can't join if

1. 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
10. 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
11. Receipt of live vaccines (including attenuated) within 30 days of first administration of Cemiplimab
12. Pregnancy or lactation period.
13. Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.
14. Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results

See the full eligibility criteria

Who can join

1. Signed informed consent form available.
10. Negative serum pregnancy test done less than or equal to 7 days prior to enrollment, for females of childbearing potential only.
11. 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
2. Patient* 18 years or older at time of signing informed consent form. * There are no data that indicate special gender distribution. *Therefore, patients will be enrolled in the study gender-independently
3. 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)
4. 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)
5. Expected survival of at least 6 months
6. ECOG performance status 0 or 1
7. Adequate laboratory parameters particularly for the blood count, renal and liver function parameters. a) Absolute number of neutrophils ≥ 1.5 x 109/L b) Platelets ≥ 75 x 109/L c) Hemoglobin ≥ 9 g/dL d) 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) e) AST (SGOT) and ALT (SGPT) ≤ 3x ULN f) AP ≤ 2.5x ULN g) Serum creatinine ≤ 2x ULN or creatinine clearance ≥ 40 mL/min
8. Absence of other severe comorbidities
9. 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.

What rules you out

1. 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
10. 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
11. Receipt of live vaccines (including attenuated) within 30 days of first administration of Cemiplimab
12. Pregnancy or lactation period.
13. Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.
14. Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
15. Legal incapacity or limited legal capacity.
16. On-treatment participation in another clinical trial in the period 30 days prior to start of the study treatment and during the study
2. 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
3. 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
4. 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
5. 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.
6. Known allergic/hypersensitive reaction to the study drug and any of its excipients or history of documented allergic/hypersensitive reactions to antibody treatments
7. 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 remin 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]
8. History of pneumonitis within the last 3 years
9. 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)

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.