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A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1

Study testing BNT113 and Pembrolizumab for HPV16-positive head and neck cancer.

Recruiting
18 years and older
All
Phase 2

This study is for patients with a specific type of head and neck cancer related to a virus called Human Papilloma Virus 16 (HPV16). The aim is to compare two treatments: a combination of a new drug, BNT113, with another drug called pembrolizumab, versus just using pembrolizumab alone. Pembrolizumab helps the immune system fight cancer.

The trial has two parts. Part A checks the safety of the BNT113 and pembrolizumab combination. Part B compares the effectiveness of the combination against pembrolizumab alone. Patients must have cancer that cannot be removed by surgery and that shows a protein called PD-L1.

  • Duration: The trial involves multiple visits for treatment and testing.
  • Eligibility: You must be 18 or older, have not had certain treatments before, and be able to follow the trial schedule.
  • Risks: There may be side effects, and not all patients will receive the combination treatment.

Consider joining if you meet the criteria and are interested in trying a new potential treatment for your cancer.

Study details
    Unresectable Head and Neck Squamous Cell Carcinoma
    Metastatic Head and Neck Cancer
    Recurrent Head and Neck Cancer

NCT04534205

BioNTech SE

2 February 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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