Anti-PD1-antibody and Pulsed HHI for Advanced BCC

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 18, 2021

Primary Completion Date

December 30, 2024

Study Completion Date

December 30, 2024

Conditions
Basal Cell Carcinoma
Interventions
DRUG

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."

Trial Locations (1)

8058

University Hospital Zurich, Clinic of Dermatology, Zurich

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

collaborator

Sun Pharmaceutical Industries Ltd

UNKNOWN

lead

Reinhard Dummer

OTHER

NCT04679480 - Anti-PD1-antibody and Pulsed HHI for Advanced BCC | Biotech Hunter | Biotech Hunter