Who may be eligible for this head and neck cancer clinical trial?

Adults aged 18 years or older with recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma that expresses PD-L1 with a combined positive score of 1 or higher may be eligible. Patients should not have received prior systemic anticancer therapy for incurable disease and must meet other health criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this head and neck cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or lodging costs.

Actively Recruiting

Phase 2

Phase 3

Age: 18Years +

All Genders

ID04534205

An Open-label Phase IIIII Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as First Line Therapy in Patients With Unresectable Recurrent or Metastatic HPV16-Positive Head and Neck Squamous Cell Carcinoma Expressing PD-L1

Q: What is BNT113 studying for head and neck cancer?

BNT113 is being studied in combination with pembrolizumab to evaluate its safety and effects compared to pembrolizumab alone in patients with unresectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma. The study aims to gather important data on treatment outcomes in this specific patient group, supported by BioNTech SE.

Led by BioNTech SE · Updated on 2026-05-22

350

Participants Needed

195

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC that tests positive for human papillomavirus 16 HPV16 and expresses the protein PD-L1. This Phase IIIII trial includes patients whose tumors have a combined positive score of 1 or higher for PD-L1. The study is designed to generate important safety and efficacy data for these treatments in this patient group. The trial consists of two parts Part A is a non-randomized safety run-in phase to confirm the safety and tolerability of BNT113 with pembrolizumab. Part B is a randomized phase comparing BNT113 combined with pembrolizumab versus pembrolizumab alone. Treatments are given by intravenous injection or infusion. Patients may receive treatment for up to 24 months. An optional pre-screening phase allows tumor samples to be tested centrally for HPV16 DNA and PD-L1 expression before entering the main trial. Participants will undergo regular assessments including monitoring for treatment-emergent adverse events, overall survival, and progression-free survival for up to 48 months. Researchers will also measure response rates and duration, disease control, and any dose adjustments due to side effects. Patients provide tumor tissue samples before treatment and are monitored closely throughout the study period. The trial aims to collect comprehensive data on safety, treatment effects, and patient outcomes over this extended follow-up.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 years or older
Histologically confirmed recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma considered incurable by local therapies
Tumor expresses PD-L1 with a combined positive score of 1 or higher as determined by approved testing
No prior systemic anticancer therapy in the incurable recurrent or metastatic setting; prior therapy completed more than 180 days before randomization is allowed if part of multimodal treatment for locally advanced disease
Measurable disease based on RECIST 1.1 criteria
Provision of tumor tissue sample from archival tissue or fresh biopsy preferably from a current metastatic or recurrent site

You will not qualify if you...

Primary tumor site is nasopharynx of any histology
Another primary malignancy not in complete remission for at least 2 years, except certain low-risk cancers
Chronic systemic immunosuppressive treatment exceeding prednisone 10 mg daily within 7 days before first trial dose
Prior treatment with immune-modulating agents within 4 weeks or five half-lives before first BNT113 dose, or unresolved immune-related adverse events
Prior treatment with live attenuated vaccines within 4 weeks before first BNT113 dose
Prior investigational drug treatment within 4 weeks or five half-lives before first BNT113 dose
Ongoing therapeutic oral or intravenous antibiotic treatment (prophylactic antibiotics allowed)
Prior treatment with anti-cancer immunomodulating agents within 4 weeks or five half-lives before first BNT113 dose
Non-systemic anti-cancer therapy within 2 weeks prior to randomization (except allowed bone resorptive therapies)
Other protocol defined criteria may apply

Research Team

BioNTech clinical trials patient information

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