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NCT04534205 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Metastatic Head and Neck Cancer and Recurrent Head and Neck Cancer, sponsored by BioNTech SE.

Recruiting
Registry status
Phase 2
Development phase
350
Enrollment target
20
Study locations

NCT04534205 is a Phase 2 study of Metastatic Head and Neck Cancer and Recurrent Head and Neck Cancer that is actively recruiting participants, run by BioNTech SE. The registered enrollment target is 350 participants, above the 107-participant average among 5 other Metastatic Head and Neck Cancer trials with a reported enrollment target (227% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT04534205, a Phase 2 study of Metastatic Head and Neck Cancer and Recurrent Head and Neck Cancer, is actively recruiting participants, sponsored by BioNTech SE.

RECRUITING
Registry status
Phase 2
Development phase
350 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

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

Interventions

  • BIOLOGICAL Pembrolizumab
  • BIOLOGICAL BNT113

Study Locations (20)

California

  • California Research Institute - Los Angeles
  • UCLA Cancer Care - Los Angeles
  • Stanford Cancer Institute - Palo Alto

Other

  • Centro de Oncología e Investigación Buenos Aires COIBA - Berazategui
  • Hospital Britanico de Buenos Aires - Ciudad de Buenos Aires
  • Instituto de Oncologia de Cordoba - Córdoba

Georgia

  • University Cancer and Blood Center - Athens
  • Winship Cancer Institute - Atlanta

New York

  • Icahn School of Medicine at Mount Sinai - New York
  • Montefiore Medical Center - The Bronx

Connecticut

  • Yale University - New Haven

District of Columbia

  • The George Washington Cancer Center - Washington D.C.

Florida

  • University of Miami Miller School of Medicine - Miami

Kentucky

  • Norton Cancer Institute - Louisville

Trial Details

FieldValue
Enrollment Target 350 participants
Start Date 2021-01-07
Est. Completion 2029-04
Phase Phase 2

Sponsor

BioNTech SE

53 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04534205

The ClinicalTrials.gov registry entry for NCT04534205 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 107-participant average among 5 other Metastatic Head and Neck Cancer trials with a reported enrollment target (227% higher). The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Metastatic Head and Neck Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT04534205 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Other, Georgia.

Frequently Asked Questions

What is clinical trial NCT04534205 about?

NCT04534205 is a clinical study titled "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 ...

What is the current status of trial NCT04534205?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 350 participants. The study started on 2021-01-07. Estimated completion is 2029-04.

What conditions does trial NCT04534205 study?

This clinical trial studies the following conditions: Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer, Unresectable Head and Neck Squamous Cell Carcinoma.

What interventions are being tested in trial NCT04534205?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), BNT113 (BIOLOGICAL).

Who is sponsoring clinical trial NCT04534205?

This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04534205 being conducted?

This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.