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

Official Title

An Open Label Phase II 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 (AHEAD-MERIT)

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.

Trial Description

Primary Outcome:

• Part A - Occurrence of treatment-emergent adverse event (TEAE) - BNT113 in combination with pembrolizumab
• Part B - Overall Survival (OS)
• Part B - Overall response rate (ORR) assessed by blinded independent central review (BICR)

• Overall response rate (ORR) by investigator's assessment
• Progression free survival (PFS)
• Disease control rate (DCR)
• Duration of Response (DOR)
• Occurrence of TEAE - BNT113 in combination with pembrolizumab compared to pembrolizumab monotherapy
• Occurrence of dose reduction and discontinuation of trial treatments due to TEAEs
• Patient-reported outcome (PRO) EORTC Quality of Life Questionnaire Core 30 (QLQ-C30)
• PRO European Quality of Life 5 Dimensions (EQ-5D)
• PRO EORTC Quality of life - Head and Neck Cancer Module (QLQ-H&N35)
• Time to deterioration in PRO scores EORTC QLQ-C30
• Time to deterioration in PRO scores EuroQol EQ-5D
• Time to deterioration in PRO scores EORTC QLQ-H&N35

View this trial on ClinicalTrials.gov