HPV Positive Oropharyngeal Squamous Cell CarcinomaPhase 1/2NCT06016920
Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma
A Phase 1/2 study testing VB10.16 and Pembrolizumab in people with HPV Positive Oropharyngeal Squamous Cell Carcinoma and HNSCC, run by Nykode Therapeutics ASA at 12 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV Positive Oropharyngeal Squamous Cell Carcinoma, HNSCC
- What is being tested?
- VB10.16 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 12 sitesin 7 countries
- Study dates
- 19 Dec 2023to Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
12 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
Senior Clinical Trial Manager contact
12 sites in 7 countries
Spain3 sites, 3 recruiting
- Recruiting
Hospital del Mar
Barcelona
- Recruiting
ICO Hospitalet (Hospital Duran i Reynals)
Barcelona
- Recruiting
MD Anderson Cancer Center
Madrid
France2 sites, 2 recruiting
- Recruiting
CRLC Val d'Aurelle - Institut de Recherche en Cancerologie de Montpellier (IRCM)
Montpellier, 34298
- Recruiting
Institut Gustave Roussy
Paris
Norway2 sites, 2 recruiting
- Recruiting
University of Bergen, Haukeland University Hospital
Bergen
- Recruiting
Oslo Universitetssykehus
Oslo
Poland2 sites, 2 recruiting
- Recruiting
Uniwersyteckie Cetrum Kliniczne
Gdansk
- Recruiting
Narodowy Instytut Onkologii-im Marii Sklodowskiej-Curie Panstwowy Instytut
Gliwice
Germany1 site, 1 recruiting
- Recruiting
Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Hals, Nasen- und Ohrenheilkunde
Giessen
United Kingdom1 site, 1 recruiting
- Recruiting
East and North Hertfordshire NHS Trust Mount Vernon Hospital
London
About this study
Official title: 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).
Read the detailed description
This Phase 1/2, open-label, dose-escalation and randomized trial is designed to evaluate the safety, tolerability, anti-tumor activity and immunogenicity of VB10.16 in combination with pembrolizumab in patients with HPV16-positive, PD-L1-positive unresectable recurrent or metastatic (r/m) oropharyngeal HNSCC, who are eligible for pembrolizumab monotherapy as standard of care (SoC) in the first-line setting. The trial consists of 2 consecutive phases with separate patient groups and is designed to determine the RP2D of VB10.16 in combination with pembrolizumab through dose-escalation of 3 mg, 6 mg, and 9 mg VB10.16, and to evaluate efficacy of the RP2D of VB10.16 when combined with pembrolizumab compared to pembrolizumab alone in Phase 2.
Phase 1: The dose escalation Phase 1 will consist of 3 dosing cohorts to evaluate VB10.16 at 3 mg (Cohort 1), 6 mg (Cohort 2), and 9 mg (Cohort 3). The 3 mg cohort will utilize a partial accelerated titration approach with a single patient41. The 6 mg cohort will follow a standard titration with 3 patients, and the 9 mg cohort will include a minimum of 6 patients to safety-clear the dose as a potential RP2D in the randomized phase.
Phase 2: 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). Allocation will be 1:1 by centralized block randomization, stratified by PD-L1 expression (CPS 1-19 versus ≥20) and ECOG PS (0 versus 1) Treatment duration is up to 2 years or until disease progression, unacceptable toxicity, withdrawal of consent, or death.
- Being tested
- VB10.16, Pembrolizumab
- Keywords
- Unresectable, recurrent, metastatic, HPV16 positive, PD-L1
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VB10.16Biological
Intramuscular injection using a PharmaJet needle-free injection system
PembrolizumabDrug
Also called KEYTRUDA®
Intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Phase1: Dose Escalation: 3 mg VB10.16 + Pembrolizumab | Experimental | 3 mg of VB10.16 via i.m. needle-free injections in the deltoid muscles
Pembrolizumab will be given as standard of care/ background medication via i.v. infusions Receives: Biological: VB10.16; Drug: Pembrolizumab |
| Phase 1: Dose Escalation: 6 mg VB10.16 + Pembrolizumab | Experimental | 6 mg of VB10.16 via i.m. needle-free injections in the deltoid muscles and quadriceps or gluteus muscles
Pembrolizumab will be given as standard of care/ background medication via i.v. infusions Receives: Biological: VB10.16; Drug: Pembrolizumab |
| Phase 1: Dose Escalation: 9 mg VB10.16 + Pembrolizumab | Experimental | 9 mg of VB10.16 via i.m. needle-free injections in the deltoid muscles and quadriceps and/or gluteus muscle
Pembrolizumab will be given as standard of care/ background medication via i.v. infusions Receives: Biological: VB10.16; Drug: Pembrolizumab |
| Phase 2: Arm A: VB10.16 (recommended Phase 2 Dose) + Pembrolizumab | Experimental | Patients randomized to receive VB10.16 at the Recommended Phase 2 Dose (RP2D) in combination with pembrolizumab. Patients will receive pembrolizumab plus the selected RP2D of VB10.16. Receives: Biological: VB10.16; Drug: Pembrolizumab |
| Phase 2: Active comparator ph 2, Arm B: Pembrolizumab Monotherapy | Experimental | Patients randomized to receive pembrolizumab monotherapy. Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Dose Escalation: Dose Limiting Toxicities (DLT)
Proportion of patient with Dose Limiting Toxicities (DLTs).
Measured: 42 days
Phase 2: Dose expansion: Objective Response Rate (ORR)
Objective Response Rate (ORR), defined as the proportion of patients who have either confirmed CR or confirmed PR as best overall response per RECIST 1.1.
Measured: Up to 2 years
Phase 2: Dose Expansion: Progression-Free Survival (PFS)
PFS defined as the time from randomization to the first documented disease progression according to RECIST 1.1 or death from any cause, whichever occurs first.
Measured: Up to 2 years
Secondary outcomes (6)
Phase 2: Dose Expansion: Disease Control Rate (DCR)
Disease control rate (DCR), defined as the proportion of patients who have either confirmed CR, confirmed PR, or SD as BOR according to RECIST 1.1.
Measured: Up to 2 years
Phase 2: Dose Expansion: Duration of response (DOR)
Duration of response (DOR), defined as time from the date of first documented response of CR or PR to the date of the first documented progression or death due to any cause.
Measured: Up to 2 years
Phase 2: Dose Expansion: Duration of complete response (DOCR)
Duration of complete response (DOCR), defined as time from the date of first documented response of CR to the date of the first documented progression or death due to any cause.
Measured: Up to 2 years
Phase 2: Dose Expansion: Duration of Disease Control (DODC)
Duration of Disease Control (DODC), defined as time from the date of first documented response of CR, PR or SD to the date of the first documented progression or death due to any cause.
Measured: Up to 2 years
Phase 2: Dose Expansion: Time to Response (TTR)
Time to Response (TTR), s defined as the time from VB10.16 treatment start date to the date of first documented response of either confirmed CR or confirmed PR.
Measured: Up to 2 years
Phase 1+2: Incidence of Treatment-Emergent and Treatment-Related Adverse Events (TEAEs) and (TRAEs)
Number and percentage of participants experiencing treatment-emergent/Treatment related adverse events, including Grade ≥3 adverse events, serious adverse events (SAEs), adverse events leading to treatment discontinuation, and adverse events of special interest.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start19 Dec 2023
- Primary completionJan 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV Positive Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dose-finding trial, including a dose escalation phase (phase 1) where participants are allocated sequentially to one of the 3 escalating doses; and a dose expansion phase (phase 2a) where participants are randomized to one of two doses.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nykode Therapeutics ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Åse Bratland, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016920
- Sponsor's protocol ID
- VB-C-03
- Other IDs
- 2022-503055-26-00, KEYNOTE-E72, MK-3475-E72
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2023
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06016920
- Acronym / sponsor ID
- VB-C-03
- Keywords
- Unresectable, recurrent, metastatic, HPV16 positive, PD-L1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Nykode Therapeutics ASAIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This Phase 1/2, open-label, dose-escalation and randomized trial is designed to evaluate the safety, tolerability, anti-tumor activity and immunogenicity of VB10.16 in combination with pembrolizumab in patients with HPV16-positive, PD-L1-positive unresectable recurrent or metastatic (r/m) oropharyngeal HNSCC, who are eligible for pembrolizumab monotherapy as standard of care (SoC) in the first-line setting. The trial consists of 2 consecutive phases with separate patient groups and is designed to determine the RP2D of VB10.16 in combination with pembrolizumab through dose-escalation of 3 mg, 6 mg, and 9 mg VB10.16, and to evaluate efficacy of the RP2D of VB10.16 when combined with pembrolizumab compared to pembrolizumab alone in Phase 2.
Phase 1: The dose escalation Phase 1 will consist of 3 dosing cohorts to evaluate VB10.16 at 3 mg (Cohort 1), 6 mg (Cohort 2), and 9 mg (Cohort 3). The 3 mg cohort will utilize a partial accelerated titration approach with a single patient41. The 6 mg cohort will follow a standard titration with 3 patients, and the 9 mg cohort will include a minimum of 6 patients to safety-clear the dose as a potential RP2D in the randomized phase.
Phase 2: 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). Allocation will be 1:1 by centralized block randomization, stratified by PD-L1 expression (CPS 1-19 versus ≥20) and ECOG PS (0 versus 1) Treatment duration is up to 2 years or until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Dose-finding trial, including a dose escalation phase (phase 1) where participants are allocated sequentially to one of the 3 escalating doses; and a dose expansion phase (phase 2a) where participants are randomized to one of two doses.
| Arm | Type | Receives |
|---|---|---|
| Phase1: Dose Escalation: 3 mg VB10.16 + Pembrolizumab | Experimental | Biological: VB10.16, Drug: Pembrolizumab3 mg of VB10.16 via i.m. needle-free injections in the deltoid muscles Pembrolizumab will be given as standard of care/ background medication via i.v. infusions |
| Phase 1: Dose Escalation: 6 mg VB10.16 + Pembrolizumab | Experimental | Biological: VB10.16, Drug: Pembrolizumab6 mg of VB10.16 via i.m. needle-free injections in the deltoid muscles and quadriceps or gluteus muscles Pembrolizumab will be given as standard of care/ background medication via i.v. infusions |
| Phase 1: Dose Escalation: 9 mg VB10.16 + Pembrolizumab | Experimental | Biological: VB10.16, Drug: Pembrolizumab9 mg of VB10.16 via i.m. needle-free injections in the deltoid muscles and quadriceps and/or gluteus muscle Pembrolizumab will be given as standard of care/ background medication via i.v. infusions |
| Phase 2: Arm A: VB10.16 (recommended Phase 2 Dose) + Pembrolizumab | Experimental | Biological: VB10.16, Drug: PembrolizumabPatients randomized to receive VB10.16 at the Recommended Phase 2 Dose (RP2D) in combination with pembrolizumab. Patients will receive pembrolizumab plus the selected RP2D of VB10.16. |
| Phase 2: Active comparator ph 2, Arm B: Pembrolizumab Monotherapy | Experimental | Drug: PembrolizumabPatients randomized to receive pembrolizumab monotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VB10.16Intramuscular injection using a PharmaJet needle-free injection system | Biological | Phase 1: Dose Escalation: 6 mg VB10.16 + Pembrolizumab, Phase 1: Dose Escalation: 9 mg VB10.16 + Pembrolizumab, Phase 2: Arm A: VB10.16 (recommended Phase 2 Dose) + Pembrolizumab, Phase1: Dose Escalation: 3 mg VB10.16 + Pembrolizumab |
| PembrolizumabAlso: KEYTRUDA®Intravenous infusion. | Drug | Phase 1: Dose Escalation: 6 mg VB10.16 + Pembrolizumab, Phase 1: Dose Escalation: 9 mg VB10.16 + Pembrolizumab, Phase 2: Active comparator ph 2, Arm B: Pembrolizumab Monotherapy, Phase 2: Arm A: VB10.16 (recommended Phase 2 Dose) + Pembrolizumab, Phase1: Dose Escalation: 3 mg VB10.16 + Pembrolizumab |
Primary outcome
Phase 1: Dose Escalation: Dose Limiting Toxicities (DLT)
Time frame: 42 days
Proportion of patient with Dose Limiting Toxicities (DLTs).
Phase 2: Dose expansion: Objective Response Rate (ORR)
Time frame: Up to 2 years
Objective Response Rate (ORR), defined as the proportion of patients who have either confirmed CR or confirmed PR as best overall response per RECIST 1.1.
Phase 2: Dose Expansion: Progression-Free Survival (PFS)
Time frame: Up to 2 years
PFS defined as the time from randomization to the first documented disease progression according to RECIST 1.1 or death from any cause, whichever occurs first.
6 secondary outcomes
Phase 2: Dose Expansion: Disease Control Rate (DCR)
Time frame: Up to 2 years
Phase 2: Dose Expansion: Duration of response (DOR)
Time frame: Up to 2 years
Phase 2: Dose Expansion: Duration of complete response (DOCR)
Time frame: Up to 2 years
Phase 2: Dose Expansion: Duration of Disease Control (DODC)
Time frame: Up to 2 years
Phase 2: Dose Expansion: Time to Response (TTR)
Time frame: Up to 2 years
Phase 1+2: Incidence of Treatment-Emergent and Treatment-Related Adverse Events (TEAEs) and (TRAEs)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Senior Clinical Trial Manager contact
Åse Bratland, MD, PhD principal investigator
Oslo University Hospital
12 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VB10.16 and Pembrolizumab in people with HPV Positive Oropharyngeal Squamous Cell Carcinoma and HNSCC, run by Nykode Therapeutics ASA at 12 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain, France, Norway, Poland, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chief Medical Officer (+47 22 95 81 93, roliveri@nykode.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Dose Escalation: Dose Limiting Toxicities (DLT) (time frame: 42 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.