At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 138 enrolled
Drug / intervention
cemiplimabdrug
Likely dose
Not stated in record
Key inclusion· 7
- ✓Confirmed diagnosis of invasive basal cell carcinoma (BCC)
- ✓Disease progression on hedgehog inhibitor (HHI) therapy OR intolerance of prior HHI therapy
- ✓At least 1 measurable lesion
- ✓Age ≥18 years
Key exclusion· 11
- ✕Ongoing or recent significant autoimmune disease
- ✕Prior treatment with PD-1/PD-L1 pathway blockers
- ✕Prior immune-modulating agents within 28 days before cemiplimab
- ✕Untreated brain metastasis that may be considered active
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating cemiplimab for Carcinoma, Basal Cell. Completed, enrolled 138 participants across 71 sites in 10 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Basal Cell
CountriesAustria, Belgium, Canada, France, Germany, Greece, Italy, Spain, Switzerland, United States
CollaboratorsSanofi
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartJun 2017
Primary CompletionMay 2021
Study CompletionApr 2023
TodayJul 2026
First PostedApr 28, 2017
Enrollment StartJun 29, 2017
Primary CompletionMay 20, 2021
Study CompletionApr 27, 2023
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 9.2 years ago
Interventions
cemiplimabdrug
Regimen as per protocol