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

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NCT04534205 · readout ≤ 985 d

Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →.

Phase

Phase 2/3

Status

Recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

350estimated

Sites

195

Countries

Argentina, Australia, Austria +20

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2021-01-07

actual

When the study began enrolling

Primary completion

Apr 2029

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Apr 2029

estimated

The whole study's end, after follow-up

First posted

2020-09-01

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-21

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

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

Interventions

Biological: BNT113
Biological: Pembrolizumab

Primary outcomes

what the primary-completion date above is the date OF

Part A - Occurrence of treatment-emergent adverse event (TEAE) - BNT113 in combination with pembrolizumab

measured up to 27 months

Part B - Overall survival (OS)

measured up to 48 months

Part B - Progression-free survival (PFS)

measured up to 48 months

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