OncoMatch/Clinical Trials/NCT06016920
Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma
Is NCT06016920 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including VB10.16 and Pembrolizumab for hpv positive oropharyngeal squamous cell carcinoma.
Treatment: VB10.16 · Pembrolizumab — 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 combination with pembrolizumab versus pembrolizumab monotherapy The goal of Phase 1 is to evaluate the safety and tolerability of the combined treatment and to decide on the dose of VB10.16 to be used in the second part of the trial. The randomized Phase 2 will consist of 2 parallel arms exploring VB10.16 at the selected RP2D from the escalation phase in combination with pembrolizumab SoC (experimental arm, Arm A), versus pembrolizumab alone (control arm, Arm B).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HPV16 positive
HPV16 positivity of r/m oropharyngeal HNSCC confirmed by designated central laboratory
Required: PD-L1 (CD274) expression (CPS ≥1)
PD-L1 positivity (CPS ≥1) using the validated PD-L1 IHC 22C3 pharmDx (DAKO) assay
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic antineoplastic therapy in r/m HNSCC setting
Any prior investigational or approved systemic antineoplastic drug or invasive medical device (including ICIs), either as monotherapy or as part of a combination regimen administered in the r/m HNSCC setting
Cannot have received: immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, CTLA-4, OX40, CD137, pembrolizumab)
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), including pembrolizumab in the locoregional setting
Cannot have received: HPV16 vaccine
Prior administration with a therapeutic HPV16 vaccine
Cannot have received: autologous or allogeneic hematopoietic stem cell transplantation
Prior autologous or allogeneic hematopoietic stem cell transplantation (HSCT)
Cannot have received: solid organ or tissue transplantation
Exception: except corneal transplant
Prior solid organ or tissue transplantation (except corneal transplant)
Cannot have received: CAR-T cell therapy
Prior chimeric antigen receptor T (CAR-T) cell therapy
Cannot have received: monoclonal or bispecific antibody or antibody fragment engaging T-cells
Prior therapy with a monoclonal or bispecific antibody or antibody fragment (or other molecules with similar mechanism of action) that engages T-cells
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06016920 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic antineoplastic therapy in r/m HNSCC setting, immune checkpoint inhibitor, HPV16 vaccine disqualifies patients from enrollment.
Does this trial require HPV16?
Yes, HPV16 positive is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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