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Study on the Safety and Effectiveness of VB10.16 and Pembrolizumab for Patients with HPV16-Positive Head and Neck Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as Head and Neck Squamous Cell Carcinoma that is positive for HPV16 (Human Papilloma Virus) and cannot be removed by surgery. The study is investigating the effects of two treatments: VB10.16, a solution for injection, and Pembrolizumab, also known by its brand name KEYTRUDA, which is a concentrate for solution for infusion. The purpose of the study is to evaluate the safety and effectiveness of these treatments when used together in patients with this specific type of cancer.

The study will be conducted in two phases. In the first phase, different doses of VB10.16 will be tested to find the safest and most effective dose to use in the second phase. The second phase will focus on determining the best biological dose from the doses selected in the first phase. Throughout the study, the combination of VB10.16 and a fixed dose of Pembrolizumab will be evaluated for its ability to treat the cancer effectively.

Participants in the study will receive the treatments and be monitored for their response to the therapy, including any side effects they may experience. The study aims to understand how well the combination of these treatments works in controlling the cancer and improving patient outcomes. The trial will also assess the immune response to the treatments, particularly focusing on the body's ability to fight the cancer cells. The study is expected to continue until 2027.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Blood tests are performed to check levels of platelets, neutrophils, hemoglobin, bilirubin, liver enzymes, and kidney function.

    A pregnancy test is conducted for female patients of childbearing potential.

  2. Step 2

    Treatment initiation

    The treatment involves two medications: pembrolizumab and VB10.16.

    Pembrolizumab is administered as a solution for infusion. The dosage and frequency are determined by the study protocol.

    VB10.16 is given as an intramuscular injection. The dosage is adjusted during the trial to find the optimal dose.

  3. Step 3

    Dose escalation phase

    In this phase, the safety of different doses of VB10.16 is evaluated. The goal is to identify the highest safe dose.

    Patients are monitored for any side effects or adverse reactions over a period of 42 days.

  4. Step 4

    Dose expansion phase

    This phase aims to determine the optimal biological dose of VB10.16 in combination with a fixed dose of pembrolizumab.

    Patients continue to receive the treatment and are monitored for their response to the medication.

  5. Step 5

    Ongoing monitoring

    Throughout the trial, regular check-ups are conducted to assess the patient's health and response to treatment.

    Blood tests and imaging studies may be performed to evaluate the effectiveness of the treatment and monitor for any side effects.

  6. Step 6

    End of treatment

    At the end of the treatment period, a final assessment is conducted to evaluate the overall response to the therapy.

    Patients may be asked to return for follow-up visits to monitor long-term effects and overall survival.

Who can join the trial?

17 criteria

  • Must be at least 18 years old at the time of signing the consent form.
  • Must have a platelet count of at least 100,000 per microliter of blood. Platelets are cells that help with blood clotting.
  • Must have a neutrophil count of at least 1,500 per microliter of blood. Neutrophils are a type of white blood cell important for fighting infections.
  • Must be able to give informed consent, meaning you understand the study and agree to participate.
  • Must have a hemoglobin level of at least 9.0 grams per deciliter. Hemoglobin is a protein in red blood cells that carries oxygen.
  • Must have a total bilirubin level of no more than 1.5 times the upper limit of normal, unless you have Gilbert syndrome, a mild liver disorder.
  • Must have liver enzyme levels (AST and ALT) no more than 2.5 times the upper limit of normal, or up to 5 times if you have liver metastases (cancer spread to the liver).
  • Must have alkaline phosphatase levels no more than 2.5 times the upper limit of normal, or up to 5 times if you have liver metastases.
  • Must have an INR or PT level of no more than 1.5 times the upper limit of normal, unless you are on blood thinners, in which case your levels must be within the therapeutic range.
  • Must have an estimated glomerular filtration rate (eGFR) of at least 45 mL/min/1.73 m², which measures kidney function.
  • Female patients of childbearing potential must have a negative pregnancy test within 72 hours before starting the study.
  • Female patients of childbearing potential must agree to use highly effective contraception during the study and for a specified period after the last dose of the study drugs. Male patients must agree to use condoms and refrain from sperm donation during the study and for a specified period after the last dose.
  • Must have a confirmed diagnosis of HPV16 positive oropharyngeal head and neck cancer that cannot be cured by local therapy and is eligible for treatment with pembrolizumab.
  • Must have PD-L1 positivity (a protein that can affect immune response) confirmed by a specific test.
  • Must have the primary tumor located in the oropharynx (part of the throat).
  • Must have at least one measurable lesion according to specific criteria (RECIST 1.1).
  • Must have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but can carry out light work.

Who cannot join the trial?

5 criteria

  • Patients with a type of cancer that is not related to **HPV16** (Human Papilloma Virus) in the head and neck area cannot participate.
  • Patients whose cancer can be surgically removed are not eligible.
  • Patients with cancer that has not returned or spread to other parts of the body cannot join the study.
  • Patients who are not within the specified age range for the study are excluded.
  • Patients who are part of a vulnerable population, meaning they need special protection, are not allowed to participate.
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Investigated drugs

  • VB10.16

    is a type of treatment designed to help the body's immune system recognize and fight cancer cells. It is specifically being tested for its ability to target cancers that are linked to a virus called HPV16, which can cause certain types of head and neck cancers. The goal of using VB10.16 in this trial is to see if it can help the immune system attack and destroy cancer cells more effectively.

  • Pembrolizumab

    is a medication that helps the immune system fight cancer by blocking a specific pathway that cancer cells use to hide from the immune system. By blocking this pathway, pembrolizumab allows the immune system to better detect and attack cancer cells. It is already used to treat various types of cancer and is being tested in this trial to see how well it works in combination with VB10.16 for treating head and neck cancers associated with HPV16.

What is already known about the treatment

  • VB10.16

    VB10.16 is administered as an injection and is currently being studied in clinical trials for its potential use in treating certain types of head and neck cancer that are linked to the Human Papilloma Virus (HPV16). This medication is being tested to see if it can safely and effectively work with another drug, pembrolizumab, to help the immune system fight cancer. VB10.16 is designed to stimulate the body's immune response specifically against cancer cells that have the HPV16 virus. It falls under the category of immunotherapy, which is a type of treatment that uses the body's own immune system to help fight cancer.

  • Pembrolizumab

    Pembrolizumab is given as an intravenous infusion and is already approved for use in various cancers, including certain head and neck cancers. It works by blocking a specific protein on immune cells, which helps the immune system recognize and attack cancer cells more effectively. Pembrolizumab is classified as a checkpoint inhibitor, a type of immunotherapy that helps the immune system target and destroy cancer cells. In this trial, it is being used in combination with VB10.16 to explore enhanced treatment effects for HPV16-positive head and neck cancer.

Investigated diseases

Unresectable recurrent or metastatic HPV16 positive oropharyngeal Head and Neck Squamous Cell Carcinoma – This disease is a type of cancer that occurs in the oropharynx, which is part of the throat behind the mouth. It is associated with the Human Papilloma Virus type 16 (HPV16) and is characterized by the presence of cancer cells that cannot be surgically removed. The cancer may recur after initial treatment or spread to other parts of the body, known as metastasis. As the disease progresses, it can lead to symptoms such as difficulty swallowing, persistent sore throat, and changes in voice. The progression involves the growth and spread of cancerous cells, which can invade nearby tissues and organs. The disease is monitored for changes in size and spread, as well as the body's immune response to the cancer cells.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-503055-26-00Protocol codeVB-C-03Estimated enrolment109 patientsSponsorNykode Therapeutics ASA

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