Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1/Phase 2
Nykode Therapeutics ASA (Voir sur ClinicalTrials)
décembre 2023
décembre 2030
27 août 2026
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Caroline EVEN | 24/09/2026 14:40:02 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CRLC Val d'Aurelle - Institut de Recherche en Cancerologie de Montpellier (IRCM) - 34298 - Montpellier - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
- ≥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.