Tests a DNA vaccine with pembrolizumab in head and neck cancer linked to HPV16

Trial details

Who runs it

Nykode Therapeutics ASA

Trial code

NCT06016920EU 2022-503055-26-00

Record updated

26 August 2026

Original description

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:Read full original descriptionShow less

A Phase 1/2, Open-label Trial to Evaluate Safety, Immunogenicity, and Anti-tumor Activity of VB10.16 in Combination With Pembrolizumab in Patients With Unresectable Recurrent or Metastatic HPV16-positive Head and Neck Squamous Cell Carcinoma

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).

Inclusion: ≥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.

Exclusion: Has progressive disease ≤6 months after completion of curatively intended concurrent chemoradiotherapy for locoregionally advanced r/m oropharyngeal HNSCC; Rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the investigator. PRIOR, CONCURRENT, OR FUTURE INTERVENTIONS; Has received prior palliative radiotherapy within 2 weeks of start of trial treatment or has a prior history of radiation pneumonitis; 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; Prior solid organ or tissue transplantation (except corneal transplant); Prior autologous or allogeneic hematopoietic stem cell transplantation (HSCT); Prior chimeric antigen receptor T (CAR-T) cell therapy; Prior therapy with a monoclonal or bispecific antibody or antibody fragment (or other molecules with similar mechanism of action) that engages T-cells; Has received a live or live-attenuated vaccine within 30 days prior to the first dose of trial intervention; Administration of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine within 30 days prior to trial treatment start; Prior administration with a therapeutic HPV16 vaccine; Patients receiving systemic immunosuppression with immunosuppressive agents such as cyclosporine, azathioprine, methotrexate, or tumor necrosis factor alpha (TNF-α) blockers for any concurrent condition; Chronic administration of systemic corticosteroids: prednisone >10 mg daily (or dose equivalent); 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; Has known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during trial screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of trial treatment. Accordingly, routine brain MRI at screening is not mandatory for all patients, only for those with previously treated but stable brain metastases; HNSCC DISEASE; Has disease that is suitable for local therapy with curative intent; Primary immunodeficiency, other immunosuppressive disorder, and/or other causes of immunosuppression; Primary tumor site of the oral cavity, hypopharynx, larynx or nasopharynx (any histology); New (≤6 months), progressive and/or symptomatic brain metastases; NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

ClinicalTrials.gov NCT06016920 · EU CTIS 2022-503055-26-00