NCT04679480

Anti-PD1-antibody and Pulsed HHI for Advanced BCC

A Prospective, Open, Single-arm, Single Center, Phase II Trial to Assess the Efficacy of Anti-PD1 Antibody in Combination With Pulsed Hedgehog Inhibitor in Advanced Basal Cell Carcinoma.

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Reinhard Dummer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the tumour response, safety and induction of immune response in patients with advanced BCC treated with a combination of anti-PD1 antibody and pulsed hedgehog inhibitor.

Detailed description

A prospective, open, single-arm, single center, phase II trial to assess the efficacy of anti-PD1 antibody in combination with pulsed Hedgehog inhibitor in advanced Basal Cell Carcinoma. 20 patients with advanced BCC will be included in the trial. No blinding or randomization will be conducted in this open label, non-randomized clinical trial. All of the patients will receive the investigative treatment (combination of anti-PD1 antibody and pulsed HHI therapy). The tumor response will be evaluated comparing tumour size at baseline, at each assessment, and 26 weeks after treatment initiation. The study duration from screening visit to the End of Study visit is 32 weeks with a Follow-Up 1 Visit at week 28 and Follow-Up 2 Visit at week 32. The duration of the translational part (secondary objectives) of the study is up to 24 months. If the best response any time at week 26 is partial response, patients will be offered to continue at least one of the study drugs until complete response or until a maximum of 2 years. The evaluation during this period will correspond to the standard of care with laboratory tests at each follow up and imaging every 12 weeks.

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-18
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2020-12-22
• Last updated: 2024-07-30

Locations

1 site across 1 country: Switzerland