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A study comparing BNT113 combined with pembrolizumab versus pembrolizumab alone for patients with HPV16-positive head and neck cancer that cannot be removed by surgery

Verified siteRegistered drugNo placebo
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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 studying head and neck squamous cell carcinoma that has come back, spread to other parts of the body, or cannot be removed by surgery. The cancer must test positive for human papilloma virus 16 and must express a protein called PD-L1. The trial is testing two treatments: one group will receive BNT113 combined with pembrolizumab, while another group will receive pembrolizumab alone. BNT113 is an experimental treatment given through a vein, and pembrolizumab is a medication that helps the immune system fight cancer cells. The purpose of this trial is to compare how well these two treatment approaches work and to see if the combination of BNT113 and pembrolizumab is better than pembrolizumab alone in helping patients live longer and in slowing down the growth or spread of the cancer.

The trial has two parts. The first part is a safety run-in phase where a small group of patients will receive BNT113 combined with pembrolizumab to check if the combination is safe and well-tolerated. The second part is a randomized phase where patients will be assigned by chance to receive either the combination of BNT113 and pembrolizumab or pembrolizumab alone. During the trial, doctors will monitor how the cancer responds to treatment and will check for any side effects. Patients will need to have regular visits, blood tests, and scans to see how well the treatment is working.

The trial will measure several outcomes including how long patients live, how long it takes before the cancer grows or spreads, and whether the cancer shrinks or disappears. Doctors will also carefully track any side effects that occur during treatment. The trial will use imaging scans to measure changes in tumor size and will follow patients for up to several years to gather information about the long-term effects of these treatments.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and enrollment

    Before starting the trial, a tumor tissue sample will be required. This can be from previously collected tissue stored in blocks or slides, or from a fresh biopsy if one is performed as part of standard care.

    Blood tests will be performed to check bone marrow function, liver function, kidney function, and blood clotting ability.

    A pregnancy test will be required if applicable.

    Tumor measurements will be taken using imaging scans to establish baseline measurements according to RECIST 1.1 criteria, which is a standard method for measuring tumors.

    The tumor will be tested to confirm it is positive for human papilloma virus 16 and expresses the PD-L1 protein with a score of at least 1.

  2. Step 2

    Treatment assignment

    The trial has two parts. Part A is a safety phase with a small number of patients. Part B is the main randomized phase.

    In Part B, assignment to one of two treatment groups will occur randomly. One group receives BNT113 combined with pembrolizumab. The other group receives pembrolizumab alone.

    The treatment received will depend on which group is assigned.

  3. Step 3

    Treatment administration

    Both BNT113 and pembrolizumab are administered through intravenous infusion, which means the medication is given directly into a vein.

    Pembrolizumab will be given as an infusion into a vein. The specific dosage and frequency will be determined according to the trial protocol.

    If assigned to the combination group, BNT113 will also be given as an injection or infusion into a vein, in addition to pembrolizumab.

    Treatment will continue for as long as the tumor does not grow and side effects remain manageable.

  4. Step 4

    Regular monitoring visits

    Regular visits to the trial site will be required according to the treatment schedule.

    At each visit, a physical examination will be performed and questions about any side effects or health changes will be asked.

    Blood tests will be performed regularly to monitor organ function and overall health.

    Imaging scans will be performed at scheduled intervals to measure the tumor and assess whether it is responding to treatment, staying stable, or growing.

  5. Step 5

    Safety monitoring

    All side effects will be recorded and assessed according to CTCAE version 5.0, which is a standard system for grading the severity of side effects.

    Particular attention will be paid to serious side effects, those requiring hospitalization, and any side effects that are severe (Grade 3 or higher).

    If significant side effects occur, the treatment dose may be reduced, delayed, or stopped depending on the severity.

  6. Step 6

    Response assessment

    Tumor response will be evaluated using imaging scans according to RECIST 1.1 criteria.

    The scans will be reviewed both by the treating physician and by independent experts who do not know which treatment was received.

    The response categories include complete response (tumor disappears completely), partial response (tumor shrinks significantly), stable disease (tumor neither shrinks nor grows significantly), or progressive disease (tumor grows).

    Response assessments will occur at 6 months and 12 months after starting treatment, and at additional time points as specified in the trial protocol.

  7. Step 7

    Contraception requirements during treatment

    If applicable, a highly effective method of contraception must be used during treatment and for at least 6 months after receiving the last dose of trial medication.

    Egg or sperm donation should not occur during this period.

  8. Step 8

    Continuation or discontinuation of treatment

    Treatment will continue as long as the tumor is not progressing and side effects are tolerable.

    Treatment may be stopped if the tumor grows, unacceptable side effects occur, or if withdrawal from the trial is requested.

    If treatment is stopped due to side effects, continued monitoring may still be required as part of the trial.

  9. Step 9

    Long-term follow-up

    After treatment ends, follow-up visits will continue to monitor overall survival and long-term outcomes.

    Information about health status and any disease progression will be collected during these follow-up visits.

    The trial is expected to continue collecting information until approximately April 2029.

Who can join the trial?

15 criteria

  • You must sign a written consent form before any tests or procedures for the study begin.
  • You must have adequate bone marrow function, which means your bone marrow produces enough blood cells, as shown by blood tests.
  • You must have adequate hepatic function, which means your liver is working well enough.
  • You must have adequate kidney function, measured by a test called estimated glomerular filtration rate which shows how well your kidneys filter waste from your blood. This value should be at least 30 mL per minute.
  • You must have stable and adequate coagulation, which means your blood clots normally, as determined by your doctor.
  • You must provide a sample of your tumor tissue from a previous biopsy stored in the laboratory. If this is not available, a fresh biopsy sample may be provided if it is done as part of your regular medical care before starting the study treatment.
  • If you are a woman who can become pregnant, you must not be pregnant. Women who can become pregnant, men who are sexually active with women who can become pregnant, and female partners of male patients must use a highly effective method of contraception, which means birth control, for at least 6 months after receiving the last dose of study treatment. You must also agree not to donate eggs or sperm during this time.
  • You must be at least 18 years old when you sign the consent form.
  • You must be willing and able to attend all scheduled visits, follow the treatment plan, complete laboratory tests, and meet other requirements of the study.
  • You must have recurrent or metastatic head and neck cancer that has come back or spread to other parts of the body, confirmed by laboratory examination of tissue, and is positive for HPV16, which is a specific virus. Your cancer must be considered not curable by local treatments such as surgery or radiation.
  • Your tumor must express a protein called PD-L1 with a CPS score of at least 1. CPS stands for combined positive score, which measures the amount of PD-L1 protein in your tumor. This must be confirmed by a specific approved laboratory test.
  • The original location of your cancer must be in the oropharynx (part of the throat behind the mouth), oral cavity (mouth), hypopharynx (lower part of the throat), or larynx (voice box).
  • You must not have received any previous systemic anticancer therapy, which means cancer treatment that travels through your bloodstream, for cancer that has come back or spread and cannot be cured. However, if you received such treatment more than 6 months before joining this study as part of treatment for cancer that had not yet spread, this is allowed.
  • You must have measurable disease based on a system called RECIST 1.1, which means your cancer can be measured and tracked using imaging scans. If your cancer is in an area that was previously treated with radiation, it can still be measured if it has been shown to be growing.
  • You must have an ECOG performance status of 0 or 1. This is a scale from 0 to 5 that measures how well you can perform daily activities. A score of 0 or 1 means you are able to carry out normal activities with no or only minor symptoms.

Who cannot join the trial?

3 criteria

  • The study does not list specific reasons why patients cannot participate in the trial at this time.
  • If you are interested in joining this study, your doctor will need to review your complete medical history and current health condition to determine if you are suitable for participation.
  • Standard exclusion reasons for cancer studies typically include having other active cancers, certain infections, pregnancy or breastfeeding, and serious health problems affecting major organs like the heart, liver, or kidneys, but specific criteria for this study are not provided in the available information.
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Investigated drugs

  • BNT113

    is an investigational cancer vaccine being tested in this study. It is designed to help the immune system recognize and fight cancer cells in patients with head and neck cancer that is linked to the human papilloma virus type 16. This medication is given in combination with another cancer treatment to see if it can help patients live longer and keep their cancer from getting worse.

  • Pembrolizumab

    is a type of immunotherapy medication that helps the body's immune system fight cancer. It works by blocking a protein that prevents immune cells from attacking cancer cells, allowing the immune system to better recognize and destroy tumors. In this study, it is being tested both alone and in combination with the investigational vaccine to compare which approach works better for treating head and neck cancer.

What is already known about the treatment

  • BNT113

    BNT113 is an investigational cancer vaccine currently being studied in clinical trials and not yet approved for general medical use. It is administered in combination with pembrolizumab as a first-line treatment for patients with unresectable, recurrent, or metastatic head and neck squamous cell carcinoma that is positive for human papillomavirus type 16 (HPV16). The vaccine works by training the immune system to recognize and attack cancer cells that contain HPV16 proteins, while pembrolizumab helps the immune system fight cancer by blocking a protein called PD-L1 that prevents immune cells from destroying tumor cells. This combination therapy is being tested to determine if it can help patients live longer and slow down cancer progression better than using pembrolizumab alone.

  • Pembrolizumab

    Pembrolizumab is an approved immunotherapy medication given through intravenous infusion (directly into a vein) that is widely used in cancer treatment. It belongs to a class of drugs called immune checkpoint inhibitors and is used to treat various types of cancers, including head and neck squamous cell carcinoma. The medication works by blocking a protein called PD-1 on immune cells, which prevents cancer cells from hiding from the immune system and allows the body's natural defenses to recognize and destroy tumor cells. In this clinical trial, it is being used either alone or in combination with the investigational vaccine BNT113 to treat patients with HPV16-positive head and neck cancer that has spread or cannot be removed by surgery.

Investigated diseases

  • Unresectable Head and Neck Squamous Cell Carcinoma

    This is a type of cancer that develops in the squamous cells, which are thin, flat cells that line the surfaces of the mouth, throat, voice box, and other areas of the head and neck. The term "unresectable" means that the tumor cannot be completely removed by surgery due to its location, size, or spread to nearby structures. The cancer begins when squamous cells start to grow abnormally and form tumors in these areas. As the disease progresses, the tumor may continue to grow and invade surrounding tissues. The cancer cells can multiply and spread, making surgical removal not possible.

  • Metastatic Head and Neck Cancer

    This condition occurs when cancer that started in the head or neck region spreads to other parts of the body through the bloodstream or lymphatic system. The original cancer typically begins in areas such as the mouth, throat, voice box, nose, or sinuses. When cancer cells break away from the primary tumor, they can travel to distant organs such as the lungs, liver, or bones. As the disease advances, new tumors form in these distant locations. The spreading cancer cells continue to grow and multiply in the new sites. This represents an advanced stage of head and neck cancer where the disease is no longer confined to its original location.

  • Recurrent Head and Neck Cancer

    This refers to cancer that has come back after initial treatment in the head or neck area. The cancer may return in the same location where it originally developed, in nearby tissues, or in other parts of the body. Recurrence can happen months or even years after the original cancer was treated. The returning cancer cells may have survived the initial treatment or were too small to be detected at that time. As the disease recurs, these surviving cancer cells begin to grow and multiply again. The recurrent cancer may behave similarly to the original tumor or may show different characteristics.

Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-512671-12-00Protocol codeBNT113-01Estimated enrolment359 patientsSponsorBioNTech SE

sourced from the EU Clinical Trials Register and site verification

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