Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
ISA101b, Pembrolizumab, and Cisplatin Chemoradiotherapy for Intermediate Risk HPV-16 Associated HNSCC
NCT04369937Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2020
- Primary completion
- Mar 2025
- Countries
- 1
- Modality
- Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes, Peptides
- Conditions
- head and neck squamous cell carcinoma (HNSCC)
01
Overview
Phase 2, open-label, single-arm trial of SLP-HPV-01 and pembrolizumab in head and neck squamous cell carcinoma (HNSCC). Primary endpoint: Progression-free Survival at 2 years. Started Jul 2020; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
IMRT + Pembrolizumab + Cisplatin + ISA101b
All patients receive the same combination treatment.
03
Who it enrols
Adults with newly diagnosed, intermediate risk, HPV-16 associated head and neck squamous cell carcinoma of the oropharynx, with no distant metastasis, ECOG PS 0-1, and no prior systemic or radiation therapy for HNSCC.
04
Endpoints
Primary
Progression-free Survival
Secondary
Serious Adverse Events
Beyond the preview
Go deeper on NCT04369937.
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 NCT04369937.