Safety and Efficacy of VB10.16 and Pembrolizumab in Patients with Head-Neck Squamous Cell Carcinoma (NCT06016920) | Clinical Trial Compass
RecruitingPhase 1/2
Safety and Efficacy of VB10.16 and Pembrolizumab in Patients with Head-Neck Squamous Cell Carcinoma
Czechia, France51 participantsStarted 2023-12-19
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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
✓. 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
✓. Platelets ≥100 × 10\^9/L (100,000/µL)
Exclusion criteria
✕. Has disease that is suitable for local therapy with curative intent
. Has progressive disease ≤6 months after completion of curatively intended concurrent chemoradiotherapy for locoregionally advanced R/M oropharyngeal HNSCC
✕. Primary tumor site of the oral cavity, hypopharynx, larynx or nasopharynx (any histology)
✕. Rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the investigator
✕. 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)