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A Phase 1/2a, Open-label, Dose-finding Trial to Evaluate Safety, Immunogenicity, and Anti-tumor Activity of VB10.16 and Pembrolizumab in Patients with Unresectable Recurrent or Metastatic HPV16-positive Head-Neck Squamous Cell Carcinoma
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jul 28, 2026
Report code
NCT06016920-Jul 28, 2026
NCT ID
NCT06016920
Status
RECRUITING
Phase
Phase 1/2a
Sponsor
Nykode Therapeutics ASA
Executive brief
Investment-Ready Snapshot
Nykode Therapeutics ASA is advancing VB10.16, a therapeutic DNA vaccine, in combination with pembrolizumab, a PD-1 inhibitor, for the treatment of unresectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). This dual approach leverages the established efficacy of pembrolizumab while potentially enhancing immune response through VB10.16. The market for HNSCC treatment is competitive, with several immunotherapies and targeted therapies available. Successful outcomes could position Nykode favorably against existing therapies, particularly if the combination demonstrates superior efficacy or safety profiles. Diligence should focus on the trial's safety and efficacy data, as well as the potential for regulatory pathways and market access strategies, given the increasing emphasis on personalized medicine in oncology.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT06016920
Indication
HPV Positive Oropharyngeal Squamous Cell Carcinoma
Modality
protein therapy
Target
HPV16 E6/E7-specific T-cell responses, PD-L1 pathway modulation
Intervention
VB10.16, Pembrolizumab
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.