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BioNTech clinical trials patient information
0 +49 6131 9084
patients@biontech.de


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Be Part of Research - Trial Details - 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

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

Recruiting

Open to: All Genders

Age: 18 Years - N/A

Medical Conditions

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


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


An open-label, controlled, multi-site, interventional, 2-arm, Phase II trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand -1 (PD-L1) with combined positive score (CPS) ≥1. This trial has two parts. Part A, an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab. Part B, the Randomized part of the trial to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1. For Part B, an optional pre-screening phase is available for all patients where patients' tumor samples may be submitted for central HPV16 DNA and central PD-L1 expression testing prior to screening into the main trial.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jan 2021 May 2028

Interventional

Intervention Type : Biological
Intervention Description : IV injection

Intervention Arm Group : Part A (Safety run-In) - BNT113 + Pembrolizumab;Part B (Randomized phase) - BNT113 + Pembrolizumab

Intervention Type : Biological
Intervention Description : IV infusion

Intervention Arm Group : Part A (Safety run-In) - BNT113 + Pembrolizumab;Part B (Randomized phase) - BNT113 + Pembrolizumab;Part B (Randomized phase) - Pembrolizumab monotherapy



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University Hospital Southampton NHS Foundation Trust
    Southampton
    SO16 6YD
  • Beatson West of Scotland Cancer Centre
    Glasgow
    G12 0YN
  • Oxford Cancer Centre
    Oxford
    OX3 7LE
  • The Clatterbridge Cancer Centre
    Liverpool
    L7 8YA

BioNTech clinical trials patient information
0 +49 6131 9084
patients@biontech.de



The study is sponsored by BioNTech SE




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Read full details for Trial ID: NCT04534205
Last updated 16 May 2024

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