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

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 s

Trial Details

NCT ID
NCT04534205
Phase
PHASE2 / PHASE3
Sponsor
BioNTech SE
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • BNT113
  • Pembrolizumab
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Palo Alto, California, United States|37.44188,-122.14302
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637

Key Eligibility Criteria

  • Patients must sign the written pre-screening informed consent form (ICF) before any pre-screening procedures.
  • Patients who present histologically confirmed recurrent or metastatic HPV16+ HNSCC that is considered incurable by local therapies.
  • Patients who have a tumor that expresses PD-L1 \[CPS ≥1\] as determined by the European Conformity (CE)-marked/Food and Drug Administration-approve…
  • Patients must not have had prior systemic anticancer therapy administered in the incurable recurrent or metastatic setting. Systemic therapy which …

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find HPV Positive Head and Neck Cancer Trials on Trialify →