Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Cemiplimab, Paclitaxel, and Carboplatin in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
NCT04862650Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Nov 2021
- Primary completion
- Jun 2026
- Countries
- 1
- Modality
- Immune Checkpoint Inhibitors, Antibody Conjugates, Engineered Antibody Formats
- Drugs
- cemiplimab
- Conditions
- squamous cell carcinoma of the head and neck (HNSCC)
01
Overview
Phase 2, open-label, single-arm trial of cemiplimab in squamous cell carcinoma of the head and neck (HNSCC). Primary endpoint: Overall Response Rate at 12 weeks. Started Nov 2021; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment (cemiplimab, paclitaxel, carboplatin)
Cemiplimab 350 mg Q3W + Paclitaxel 25 mg/m2 QW + Carboplatin AUC 1 QW.
03
Who it enrols
Adults with recurrent/metastatic squamous cell carcinoma of the head and neck (excluding certain specific sites like nasopharyngeal), no prior systemic therapy for R/M disease, ECOG 0-1, adequate organ function, and no prior mAb-based immunotherapy or PI3K inhibitors.
04
Endpoints
Primary
Overall Response Rate
Secondary
Progression-Free Survival
Overall Survival
Incidence of Adverse Events
Beyond the preview
Go deeper on NCT04862650.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT04862650.