ClinicaliQ Trial Snapshot
- Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma — Recruiting • Phase I • Oncology • NCT06016920.
- What is being tested: VB10.16 (therapeutic DNA vaccine) combined with pembrolizumab (PD-1 inhibitor) in patients with unresectable recurrent or metastatic HPV16-positive oropharyngeal head and neck squamous cell carcinoma.
- Patient eligibility overview: Adults with confirmed HPV16-positive oropharyngeal HNSCC that is unresectable, recurrent, or metastatic; this represents a treatment-resistant disease population with limited therapeutic options.
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- Quick orientation before opening the registry record.
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What This Trial Is Studying
This is a multi-center study in patients with un-resectable Recurrent or Metastatic HPV16-positive oropharyngeal Head and Neck Squamous Cell Carcinoma (HNSCC). The trial is designed to investigate VB10.16, an investigational therapeutic DNA vaccine in combination with another medicine, pembrolizumab, which is the standard of care for patients with previously untreated metastatic or resectable recurrent PD-L1 positive HNSCC. The study is divided in 2 parts: * Phase 1: Dose escalation to evaluate safety and determine the recommended phase 2 dose (RP2D) of VB10.16 * Phase 2: Randomized comparison of VB10.16 in…
Eligibility Snapshot
- KEY INCLUSION CRITERIA: * ≥18 years of age (or as per national legal age of trial consent, whichever is higher) at date of signing the informed consent form (ICF). * Histologically or cytologically confirmed r/m HNSCC, located in the oropharynx, considered incurable by local therapy and eligible for monotherapy with pembrolizumab. * HPV16 positivity of r/m oropharyngeal HNSCC confirmed by designated central laboratory. laboratory. * PD-L1 positivity (CPS ≥1) using the validated PD-L1 IHC 22C3 pharmDx (DAKO) assay. * Primary tumor location in the oropharynx. * At least 1 measurable lesion per RECIST 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1. * Life expectancy of ≥3 months, as determined by Gustave Roussy Immuno (GRIm) score 0-1. KEY
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.