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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

Testing BNT113 with Pembrolizumab for HPV16-related head and neck cancer.

Recruiting
18 years and older
All
Phase 2/3
This study is about testing a new cancer treatment called **BNT113** with another drug called **pembrolizumab**. It's for people with a certain type of head and neck cancer that has a virus called **HPV16** and shows a protein called **PD-L1**. The trial has two parts: Part A checks if BNT113 is safe to use with pembrolizumab. Part B compares the effects of using both drugs together versus just pembrolizumab alone. - **Length**: Treatment lasts up to 24 months. - **Visits**: Regular follow-ups are necessary. - **Risks**: Some medical conditions and previous treatments may exclude participation. The study is for patients without prior systemic therapy for this cancer type, and they must provide a sample of their tumor. If you have a different type of cancer or have taken certain treatments, you might not qualify. Participants will help researchers understand if the new combination is better than the existing treatment.
Study details
    Unresectable Head and Neck Squamous Cell Carcinoma
    Metastatic Head and Neck Cancer
    Recurrent Head and Neck Cancer

NCT04534205

BioNTech SE

27 April 2025

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