Combining a DNA vaccine with pembrolizumab for HPV-positive head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center clinical trial investigates the safety and efficacy of VB10.16, an investigational DNA vaccine, in combination with pembrolizumab for patients with unresectable recurrent or metastatic HPV16-positive oropharyngeal head and neck squamous cell carcinoma (HNSCC). The study is divided into two phases: a phase 1 dose escalation to determine the optimal dose of VB10.16 and a phase 2a dose expansion to evaluate the treatment's effectiveness at the selected dose. Participants will receive treatment for 48 weeks, after which they may continue with pembrolizumab based on the investigator's discretion. The trial aims to assess the immunogenicity and anti-tumor activity of the combination therapy.

Why it matters

Who can join: the full rules

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 Exclusion criteria:

HNSCC DISEASE

* 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. 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.
* Primary immunodeficiency, other immunosuppressive disorder, and/or other causes of immunosuppression.
* 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.
* New (≤6 months), progressive and/or symptomatic brain metastases.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it's running

• CRLC Val d'Aurelle - Institut de Recherche en Cancerologie de Montpellier (IRCM)
  Montpellier, France Recruiting
• Institut Gustave Roussy
  Paris, France Recruiting
• Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Hals, Nasen- und Ohrenheilkunde
  Giessen, Germany Recruiting
• National Institute of Oncology
  Budapest, Hungary Recruiting
• University of Bergen, Haukeland University Hospital
  Bergen, Norway Recruiting
• Oslo Universitetssykehus
  Oslo, Norway Recruiting

Study contacts

• Principal investigator: Åse Bratland, MD, PhD — Oslo University Hospital
• Study coordinator: Chief Medical Officer
• Email: roliveri@nykode.com
• Phone: +47 22 95 81 93

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CUE-101 with pembrolizumab for locally advanced HPV‑16 positive oropharyngeal cancer

  This trial tests whether CUE-101 alone or combined with pembrolizumab before definitive therapy helps people with newly diagnosed, locally advanced HPV‑16 positive oropharyngeal cancer who are HLA‑A*02:01 positive.

  Recruiting Phase 2 Yale University · New Haven, Connecticut · NCT07172256

• HCB101 plus pembrolizumab for platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma

  This trial tests whether adding HCB101 to pembrolizumab is safe and helps people with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma.

  Recruiting at 3 sites Phase 1/2 Taipei Veterans General Hospital, Taiwan · Taoyuan, Guishan District and 2 other locations · NCT07136545

• Investigating OKN4395 and Pembrolizumab for Solid Tumors

  This study is testing a new drug called OKN4395, alone and with another drug called pembrolizumab, to see if it can help people with solid tumors who have run out of other treatment options.

  Recruiting at 10 sites Phase 1 Epkin · Beverly Hills, California and 9 other locations · NCT06789172

• Comparing two and four courses of pembrolizumab with chemotherapy for head and neck cancer

  This study is testing whether getting two or four rounds of a new cancer drug along with chemotherapy helps people with head and neck cancer do better before surgery.

  Recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT05980702

• Evaluating CJRB-101 with Pembrolizumab for Advanced Cancer

  This study is testing a new treatment combining CJRB-101 with pembrolizumab to see if it helps people with advanced cancers like lung cancer and melanoma feel better and respond better to their treatment.

  Recruiting at 4 sites Phase 1/2 CJ Bioscience, Inc. · Irvine, California and 3 other locations · NCT05877430

• MQ710 with or without pembrolizumab for advanced skin and other solid tumors

  This will test different doses of MQ710, alone or together with pembrolizumab, in adults with advanced or recurrent solid tumors (including skin cancers) to find a safe dose with mild side effects.

  Recruiting at 5 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT05859074

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.