A Phase 2/3 interventional study of BNT113 and Pembrolizumab in Unresectable Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer and Recurrent Head and Neck Cancer, sponsored by BioNTech SE. Active, not recruiting at 142 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by BioNTech SE · Phase 2/3, Interventional, and Treatment
An open-label, controlled, multi-site, interventional, 2-arm, Phase II/III 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, is 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, is a randomized part 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. Patients included in the Safety Run-In Phase of the trial (Part A) will not be randomized to Part B and will continue on-trial treatment (BNT113 plus pembrolizumab) within Part A.
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.
Patients will be treated with BNT113 in combination with pembrolizumab or with pembrolizumab monotherapy for approximately up to 24 months.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 358 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →BioNTech SE is the lead sponsor of 74 studies on the registry; 23 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Medical conditions:
Prior/concomitant therapy:
Patients who have received or currently receive the following therapy/medication:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab.
Biological: BNT113 · Biological: Pembrolizumab
BNT113 in combination with pembrolizumab.
Biological: BNT113 · Biological: Pembrolizumab
Pembrolizumab monotherapy.
Biological: Pembrolizumab
IV injection
IV infusion
Part A - Occurrence of treatment-emergent adverse event (TEAE) - BNT113 in combination with pembrolizumab
TEAE assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) including Grade ≥3, serious, and fatal TEAEs, by relationship.
Time frame: up to 27 months
Part B - Overall survival (OS)
OS defined as the time from randomization to death from any cause.
Time frame: up to 48 months
Part B - Progression-free survival (PFS)
PFS defined as the time from randomization to the first objective tumor progression (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\] assessed by the blinded independent central review \[BICR\]), or death from any cause, whichever occurs first.
Time frame: up to 48 months
Part A and B - Overall response rate (ORR)
ORR defined as the proportion of patients in whom a complete response (CR) or partial response (PR) (per RECIST 1.1 assessed by BICR and investigator) is observed as best overall response.
Time frame: up to 48 months
Part A and B - Duration of response (DOR)
DOR defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective tumor progression (progressive disease \[PD\] per RECIST 1.1) or death from any cause, whichever occurs first. In Part A, assessment will be done by both BICR and investigator; in Part B, only by BICR.
Time frame: up to 48 months
Part A - Disease control rate (DCR)
DCR defined as the proportion of patients in whom a CR or PR or stable disease (SD) (per RECIST 1.1, assessed at least 6 weeks after first dose by BICR and investigator) is observed as best overall response.
Time frame: up to 48 months
Part B - Progression free survival (PFS)
PFS defined as the time from randomization to the first objective tumor progression (per RECIST 1.1 by investigator's assessment) or death from any cause, whichever occurs first.
Time frame: up to 48 months
Part B - PFS rate at 6 months
Defined as the proportion of patients without objective tumor progression (per RECIST 1.1 assessed by BICR and investigator) or death from any cause
Time frame: from randomization until 6 months after randomization
Part B - PFS rate at 12 months
Defined as the proportion of patients without objective tumor progression (per RECIST 1.1 assessed by BICR and investigator) or death from any cause.
Time frame: from randomization until 12 months after randomization
Part B - Occurrence of TEAEs - BNT113 in combination with pembrolizumab compared to pembrolizumab monotherapy
TEAEs assessed according to CTCAE v5.0 including Grade ≥3, serious, and fatal TEAEs by relationship.
Time frame: up to 27 months
Part B - Occurrence of dose reduction, delay, and discontinuation of trial treatments due to TEAEs
BNT113 in combination with pembrolizumab compared to pembrolizumab monotherapy.
Time frame: up to 27 months
Showing the first 100 of 142 sites across 21 countries.
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
BioNTech SE