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Also known as Cemiplimab Injection [Libtayo], Cemiplimab (SAR439684)
Cemiplimab · 1 trial · 1 indication
The response will be assessed according to the Immune-response Criteria (Appendix) in all patients with cutaneous lesions as: complete response, partial response, stable disease or progressive disease. The best response documented between treatment start and week 26 will be considered "best response". In case of metastatic BCC without cutaneous lesions at screening, the primary outcome will be assessed using PET/CT imaging according to the PERCIST criteria every 12 weeks from treatment start. In patient withdrawn from the trial before week 26, the last tumour assessment will be used for evaluation of primary outcome. For patients withdrawn from the study a full body physical examination and laboratory results will be performed prior to withdrawal, unless refused by the patient.
| Arm | Type | Description |
|---|---|---|
| Intervention | EXPERIMENTAL | Investigational product: a combination of an anti-PD1 antibody (Cemiplimab) and a HHI (Sonidegib). Cemiplimab will be supplied as a liquid in a sterile, single-use 10 ml vial. Each vial will contain a volume of 7ml at a concentration of 50mg/ml. Cemiplimab will be prepared for infusion at the trial site and administered as a flat 350mg dose in 100ml sodium chloride 0.9% as an IV infusion over approximately 30 minutes (±10 minutes) in an outpatient setting. Each patient's dose will be administered as a flat 350mg dose in every 3 weeks, starting from week 2 of the trial. The Hedgehog Inhibitor used for the trial will be Sonidegib. Sonidegib is a white 200mg capsule, orally administered once daily. Sonidegib will be administered in a 2 week cycle every 4 weeks (pulsed therapy: 2 weeks on, 2 weeks off), starting from week 0 of the trial. |
| Name | Type | Description |
|---|---|---|
| Cemiplimab Injection [Libtayo] | DRUG | Investigational product: a combination of an anti-PD1 antibody (Cemiplimab) and a HHI (Sonidegib). Cemiplimab will be supplied as a liquid in a sterile, single-use 10 ml vial. Each vial will contain a volume of 7ml at a concentration of 50mg/ml. Cemiplimab will be prepared for infusion (as described in SmPC (Fachinformation Swissmedic) Libtayo, see Appendix) at the trial site and administered as a flat 350mg dose in 100ml NaCl 0.9% as an IV infusion over approximately 30 minutes (±10 minutes) in an outpatient setting. Each patient's dose will be administered as a flat 350mg dose in every 3 weeks, starting from week 2 of the trial. The Hedgehog Inhibitor used for the trial will be Sonidegib. Sonidegib is a white 200mg capsule, orally administered once daily. Sonidegib will be administered in a 2 week cycle every 4 weeks (pulsed therapy: 2 weeks on, 2 weeks off), starting from week 0 of the trial. |
Inclusion Criteria: * Informed Consent as documented by signature * Histologically or cytologically confirmed advanced BCC, defined as: a) metastasized BCC, b) locally advanced BCC, not suitable for surgical or radio-therapeutic treatment c) multiple BCCs (\>5) d) BCC \>10mm; not suitable for surge...
Cemiplimab is an investigational antibody being studied for the treatment of advanced Basal Cell Carcinoma. It is currently in Phase 2 clinical development, with an active trial evaluating its use in this condition. The drug is not yet approved and remains under investigation.
Cemiplimab is a monoclonal antibody, indicated by its -mab suffix, that targets the PD-1 pathway. It is being studied in oncology for Basal Cell Carcinoma, where it may modulate immune responses against cancer cells.
Cemiplimab is developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical research on this drug for the treatment of Basal Cell Carcinoma.
Cemiplimab is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in patients with Basal Cell Carcinoma.
Cemiplimab is being studied in a Phase 2 clinical trial with the identifier NCT04679480, titled 'Anti-PD1-antibody and Pulsed HHI for Advanced BCC'. This active, non-recruiting trial enrolls 20 participants with Basal Cell Carcinoma in Switzerland.
Cemiplimab is also known as Cemiplimab Injection [Libtayo] and Cemiplimab (SAR439684). These names refer to the same drug, which is being investigated for Basal Cell Carcinoma.