NCT03132636

PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1, in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to estimate the objective response rate (ORR) for metastatic Basal Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when treated with cemiplimab as a monotherapy

Conditions

• Carcinoma, Basal Cell

Interventions

Type	Name	Description
DRUG	cemiplimab	Regimen as per protocol

Timeline

• Start date: 2017-06-29
• Primary completion: 2021-05-20
• Completion: 2023-04-27
• First posted: 2017-04-28
• Last updated: 2025-04-08
• Results posted: 2022-07-26

Locations

71 sites across 10 countries: United States, Austria, Belgium, Canada, France, Germany, Greece, Italy, Spain, Switzerland

Regulatory

• FDA-regulated drug study