Clinical Trials Logo

Clinical Trial Summary

An open-label, controlled, multi-site, interventional, 2-arm, Phase II 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, 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, the Randomized part of the trial 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. 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04534205
Study type Interventional
Source BioNTech SE
Contact BioNTech clinical trials patient information
Phone +49 6131 9084
Email patients@biontech.de
Status Recruiting
Phase Phase 2
Start date January 7, 2021
Completion date May 2028

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05738187 - Evaluation of the Efficacy and Safety of Local Cryotherapy Treatment of Recurrent Head and Neck Cancer in Irradiated Areas: a Pilot Study N/A
Recruiting NCT02567383 - Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) for Recurrent Head and Neck Cancer Phase 2
Recruiting NCT05980000 - Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma Phase 2
Active, not recruiting NCT03691714 - Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Phase 2
Terminated NCT02842125 - Safety and Efficacy of Intra-Arterial and Intra-Tumoral Ad-p53 With Capecitabine (Xeloda) or Anti-PD-1 in Liver Metastases of Solid Tumors and Recurrent Head and Neck Squamous Cell Cancer Phase 1/Phase 2
Terminated NCT04969861 - BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36) Phase 2/Phase 3
Active, not recruiting NCT04260126 - Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC Phase 2
Completed NCT02358031 - A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048) Phase 3
Completed NCT02422979 - Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer Phase 1/Phase 2
Completed NCT04902027 - A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Recurrent/Metastatic Head and Neck Cancers Phase 1
Active, not recruiting NCT02289209 - Reirradiation With Pembrolizumab in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head and Neck Phase 2
Recruiting NCT06239220 - PD-L1 t-haNK, N-803 IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC Phase 2
Recruiting NCT04673929 - Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract
Recruiting NCT03754933 - Safety and Efficacy of Repeat Administration of Ad/PNP and Fludarabine Phosphate in Patients With Local Head/Neck Cancer Phase 1/Phase 2
Terminated NCT03937141 - Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer Phase 2
Terminated NCT00088907 - Phase III Trial Of Docetaxel Versus Docetaxel Plus ZD1839 In Head And Neck Cancer Phase 3
Completed NCT01620242 - A Phase II, Open-Label, Multicenter Trial of Cabazitaxel in Patients With Recurrent or Metastatic Head and Neck Cancer After Failure Of Cisplatin, Cetuximab and Taxanes Phase 2
Terminated NCT01606566 - A Study to Evaluate the Safety and Efficacy of Amphinex Induced PCI of Bleomycin for Recurrent Head and Neck Cancer. Phase 2
Completed NCT01255800 - Pilot Study of Cetuximab and the Hedgehog Inhibitor IPI-926 in Recurrent Head and Neck Cancer Phase 1