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

Conditions

• Metastatic Head and Neck Cancer
• Recurrent Head and Neck Cancer
• Unresectable Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BNT113 — BIOLOGICAL
  IV injection
• Pembrolizumab — BIOLOGICAL
  IV infusion

Study Details

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.

Key Dates

Start date

Jan 7, 2021

Status verified

May 2026

Primary completion

Apr 30, 2029

Completion

Apr 30, 2029

Study Design

Enrollment

350 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part A (Safety Run-In) - BNT113 + Pembrolizumab
  Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab.
• Experimental: Part B (Randomized phase) - BNT113 + Pembrolizumab
  BNT113 in combination with pembrolizumab.
• Active Comparator: Part B (Randomized phase) - Pembrolizumab monotherapy
  Pembrolizumab monotherapy.

Primary Outcome Measure

Part A - Occurrence of treatment-emergent adverse event (TEAE) - BNT113 in combination with pembrolizumab [ Time Frame: up to 27 months ]

Central Contacts

• BioNTech clinical trials patient information
  +49 6131 9084
  [email protected]

Locations (19)

Find similar trials in Los Angeles, CA

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