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Tests treatment safety and results for Basal Cell Carcinoma (BCC)
Official title Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients
ClinicalTrials.gov ID: NCT06981325
What this study is testing
What is Cemiplimab?
Cemiplimab is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for basal cell carcinoma (bcc).
Also referred to as LIBTAYO.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join if
- Pretreatment with systemic immunotherapy (such as PD-1/PD-L1 or CTL4) or targeted therapy (such as hedgehog inhibitor) NOTE: Prior treatment with...
- Any other non-radiation anti-cancer therapy (e.g. imiquimod, photodynamic therapy; neither investigational nor standard of care) within 30 days (from...
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required systemic immunosuppressive therapy, excluding: vitiligo...
- Other neoplasia, in particular hematologic diseases that might impair immune response, such as chronic lymphocytic leukemia, myelodysplastic or...
- Immunosuppressive corticosteroid doses (\> 10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of Cemiplimab NOTE: Patients...
- Known allergic/hypersensitive reaction to the study drug and any of its excipients or history of documented allergic/hypersensitive reactions to...
See the full eligibility criteria
Who can 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...
- 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...
- There are no data that indicate special gender distribution. Therefore, patients will be enrolled in the study gender-independently
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Erfurt, Germany
- Erlangen, Germany
- Heidelberg, Germany
- Leipzig, Germany
- Minden, Germany
- Oberhausen, Germany
- Tübingen, Germany
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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Erfurt, Germany; Erlangen, Germany; Heidelberg, Germany; Leipzig, Germany; Minden, Germany; Oberhausen, Germany and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.