1. Best response any time between the treatment start and 26 weeks after the initiation of the treatment. (Time Frame - At baseline, each assessment and the week 26.): 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In patient withdrawn from the trial before week 26, the last tumour assessment will be used for evaluation of primary outcome. For patients withdrawn from the study a full body physical examination and laboratory results will be performed prior to withdrawal, unless refused by the patient.
Secondary outcome:
1. Tumour response at 26 weeks after the initiation of the treatment (Time Frame - 26 weeks after the initiation of the treatment): The secondary outcome tumour response at 26 weeks after treatment initiation will be evaluated at week after treatment start, or at the end of treatment, whichever comes first.
2. Detection of histologic changes in the tumour in patients with biopsy-assessable tumours (Time Frame - Histologic changes will be compared in the biopsies taken at baseline, week 2, week 26, and, if applicable, week 4 and week 12.): The following histologic changes in the tumor will be measured:
CD4 Infiltration
CD8 Infiltration
TREG FOXP3 infiltration
3. Evaluation of the changes in immunogenicity of the tumour and tumour microenvironment in patients with biopsy-assessable tumours (Time Frame - Immunogenicity will be compared in the biopsies taken at baseline, week 2, week 26, and, if applicable, week 4 and week 12.): The following changes in immunogenicity will be evaluated:
MHC-I expression
TAP-I expression
TAP-II expression
B-Catenin expression
PD-1 expression
PD-L1 expression
CD-200 expression
SOX-9 expression
BCL-2 expression
Cemiplimab Injection [Libtayo] (Sonidegib): 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.
Quelle: ClinicalTrials.gov
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"Anti-PD1-antibody and Pulsed HHI for Advanced BCC"
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