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 (May 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: a phase 1, dose escalation part, testing 3 different doses of VB10.16 in combination with a standard fixed dose of pembrolizumab. The goal of this part 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. In the second part of the trial, a phase 2a, dose expansion part, participants will receive either the highest safe dose of VB10.16 from part 1 or the 3 mg dose both in combination with pembrolizumab. The dose given to each participant will be decided in random. The trial is designed to define the optimal dose of VB10.16 in combination with pembrolizumab for future clinical studies based on the safety, tolerability and anti-tumor effect data generated.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HPV16 positivity
HPV16 positivity of R/M oropharyngeal HNSCC confirmed by designated central laboratory
Required: PD-L1 (CD274) positivity (CPS ≥1) (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 drug
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
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)
Cannot have received: HPV16 vaccine
Prior administration with a therapeutic HPV16 vaccine
Cannot have received: monoclonal or bispecific antibody or antibody fragment (or other molecule with similar mechanism of action) that engages T-cells
Prior therapy with a monoclonal or bispecific antibody or antibody fragment (or other molecule with similar mechanism of action) that engages T-cells
Cannot have received: CAR-T cell therapy
Prior chimeric antigen receptor T (CAR-T) cell therapy
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: palliative radiotherapy
Has received prior palliative radiotherapy within 2 weeks of start of trial treatment or has a prior history of radiation pneumonitis
Lab requirements
Blood counts
Platelets ≥100 × 10^9/L (100,000/µL); Neutrophils (ANC) ≥1.5 × 10^9/L (1,500/µL); Hemoglobin ≥5.6 mmol/L (9.0 g/dL)
Kidney function
Estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m^2 using the Cockroft-Gault formula
Liver function
Bilirubin (BILI), total ≤1.5 × ULN (except Gilbert syndrome, then direct BILI ≤2 × ULN) or direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN; AST ≤ 2.5 × ULN or ≤5 × ULN for a patient with liver metastases; ALT ≤ 2.5 × ULN or ≤5 × ULN for a patient with liver metastases; Alkaline phosphatase ≤ 2.5 × ULN or ≤5 × ULN for a patient with liver metastases; INR or PT ≤1.5 × ULN unless the patient is receiving anticoagulant therapy, in which case PT and PTT/aPTT must be within therapeutic range of intended use of anticoagulants
See inclusion criteria 8-15 (hematological, hepatic, hemostatic function) and 16 (renal function)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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