20
Participants
Start Date
February 18, 2021
Primary Completion Date
December 30, 2024
Study Completion Date
December 30, 2024
Cemiplimab Injection [Libtayo]
"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."
University Hospital Zurich, Clinic of Dermatology, Zurich
Collaborators (1)
Sanofi
INDUSTRY
Sun Pharmaceutical Industries Ltd
UNKNOWN
Reinhard Dummer
OTHER