At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed recurrent or metastatic HPV16+ HNSCC incurable by local therapies
- ✓PD-L1 expression CPS ≥1 by CE-marked/FDA-approved 22C3 pharmDx
- ✓Measurable disease by RECIST 1.1 confirmed by BICR
- ✓Tumor tissue sample (FFPE blocks, slides, curls, or fresh biopsy) from archival or current metastatic/recurrent disease
- ✕Primary tumor site of nasopharynx (any histology)
- ✕Another primary malignancy not in complete remission for at least 2 years (with exceptions: cervical carcinoma in situ, non-invasive skin cancer, localized prostate cancer, superficial bladder cancer, breast ductal carcinoma in situ)
- ✕Chronic systemic immunosuppressive treatment including corticosteroids >10 mg daily within 7 days prior to first dose
- ✕Ongoing treatment with therapeutic oral or IV antibiotics
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Phase II/III Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1
In Brief
A Phase 3 clinical trial evaluating BNT113 and Pembrolizumab for Unresectable Head and Neck Squamous Cell Carcinoma and 2 related conditions. Currently recruiting, targeting 350 participants across 195 sites in 23 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
IV injection
IV infusion