BNT113 and Pembrolizumab Head and Neck Cancer Study

Study overview

This open-label, randomized Phase 2 trial evaluates BNT113 in combination with pembrolizumab compared with pembrolizumab alone as first-line therapy for people with unresectable recurrent or metastatic head and neck squamous cell carcinoma. The protocol requires tumors that are positive for human papillomavirus type 16, called HPV16, and that express PD-L1.

What researchers are evaluating

Researchers are comparing the safety, tolerability, and anticancer activity of the study groups. Randomization assigns participants to a group according to the protocol. BNT113 is investigational and is designed to stimulate an immune response against selected HPV16-related targets. Its benefits and risks are not fully established. Pembrolizumab is an immunotherapy with known potential risks that the research team reviews during informed consent. Procedures may include examinations, blood tests, electrocardiograms, imaging, tumor measurements, tissue testing, medication reviews, and monitoring for side effects.

Considering participation

Eligibility may depend on cancer location and stage, HPV16 and PD-L1 test results, prior therapy, measurable disease, organ function, current medications, and overall health. Enrollment availability can change as the study progresses. Screening does not guarantee enrollment, and contacting California Research Institute does not obligate anyone to participate.

Participation is voluntary. Before enrollment, the research team explains study groups, visits, procedures, foreseeable risks, potential benefits, alternatives, privacy protections, and participant rights. Patients may consult their cancer specialist, family, or another trusted adviser before deciding.

To ask about current availability, use the secure information-request form. Do not include medical records, insurance details, or other sensitive health information. A coordinator will review the inquiry and respond.