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ACTIVE NOT RECRUITING

NCT04534205

PHASE2/PHASE3

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

Sponsor: BioNTech SE

View on ClinicalTrials.gov

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.

Official title: An Open-label Phase II/III 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

358

Start Date

2021-01-07

Completion Date

2028-08

Last Updated

2026-10-14

Healthy Volunteers

Conditions

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

Interventions

BIOLOGICAL

BNT113

IV injection

BIOLOGICAL

Pembrolizumab

IV infusion

Key Inclusion 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-approved CDx PD-L1 immunohistochemistry 22C3 pharmDx performed according to the manufacturer's instructions for use. * Patients must not have had prior systemic anticancer therapy administered in the incurable recurrent or metastatic setting. Systemic therapy which was completed more than 180 days prior to randomization, if given as part of multimodal treatment for locally advanced disease, is allowed. * Patients who have measurable disease based on RECIST 1.1 as determined by the site and confirmed by BICR. Tumor lesions situated in a previously irradiated area may be considered measurable, if progression has been demonstrated in such lesions disease by RECIST 1.1. * All patients must provide a tumor tissue sample (formalin fixed paraffin embedded \[FFPE\] blocks or both slides and curls) from archival tissue. Alternatively, a fresh biopsy sample could be provided if a biopsy sample is performed as part of the patient's standard clinical practice before the first dose of trial treatment. The sample should be preferably derived from a current site of metastatic or recurrent disease. Otherwise, a sample from the primary tumor can be submitted. Key Exclusion Criteria: Medical conditions: * Patients present primary tumor site of nasopharynx (any histology). * Patients with another primary malignancy that has not been in complete remission for at least 2 years, with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, non-invasive basal or non-invasive squamous cell skin cancer, localized prostate cancer, non-invasive superficial bladder cancer or breast ductal carcinoma in situ). Prior/concomitant therapy: * Patients who have received or currently receive the following therapy/medication: 1. Chronic systemic immunosuppressive treatment including corticosteroid treatment (prednisone \>10 mg daily orally \[PO\] or intravenously \[IV\], or equivalent) in the 7 days prior to the first dose of trial treatment. 2. Prior treatment with other immune-modulating agents that was (a) within fewer than 4 weeks (28 days) or five half-lives of the agent (whichever is longer) prior to the first dose of BNT113, or (b) associated with immune-mediated AEs that have not resolved prior to the first dose of BNT113 or that pose an additional risk of on-trial complications, per investigator's assessment, or c) associated with toxicity that resulted in discontinuation of the immune-modulating agent and that poses an additional risk of on-trial complications, per investigator's assessment. 3. Prior treatment with live attenuated vaccines within 4 weeks before the first dose of BNT113. 4. Prior treatment with an investigational drug (including investigational vaccines) within 4 weeks or five half-lives of the agent (whichever is longer) before the planned first dose of BNT113. 5. Ongoing treatment with therapeutic PO or IV antibiotics. Note: Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) may be enrolled. * Prior treatment with anti-cancer immunomodulating agents, such as blockers of programmed death receptor-1 (PD-1), PD-L1, tumor necrosis factor receptor superfamily member 9 (TNRSF9, 4 1BB, CD137), OX 40, therapeutic vaccines, cytokine treatments, or any investigational agent within 4 weeks or five half-lives of the agent (whichever is longer) before the first dose of BNT113. * Treatment with non-systemic anti-cancer therapy (e.g., radiotherapy or surgery) within 2 weeks prior to randomization. Note: Prior treatment with bone resorptive therapy, such as bisphosphonates (e.g., pamidronate, zoledronic acid) and denosumab, is allowed. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (138)

UCLA Cancer Care

Los Angeles, California, United States

Stanford Cancer Institute

Palo Alto, California, United States

Yale University

New Haven, Connecticut, United States

The George Washington Cancer Center

Washington D.C., District of Columbia, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

Winship Cancer Institute

Atlanta, Georgia, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

The University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

Memorial Sloan Kettering Cancer Center

Long Island City, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

University of Cincinnati Cancer Center

Cincinnati, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

Centro de Oncología e Investigación Buenos Aires COIBA

Berazategui, Argentina

Instituto de Oncologia de Cordoba

Córdoba, Argentina

Centro Oncologico Riojano Integral

La Rioja, Argentina

Centro de Investigacion Pergamino SA - Clinica Pergamino

Pergamino, Argentina

Instituto de Oncologia de Rosario

Rosario, Argentina

Sanatorio Britanico

Rosario, Argentina

CAIPO Centro para la Atencion Integral del Paciente Oncologico

San Miguel de Tucumán, Argentina

Cancer Research SA

Adelaide, Australia

Flinders Medical Centre

Bedford Park, Australia

St Vincent's Hospital

Fitzroy, Australia

Royal North Shore Hospital

Saint Leonards, Australia

John Flynn Private Hospital

Tugun, Australia

Southern Medical Day Care Centre

Wollongong, Australia

LKH - Univ. Klinikum Graz

Graz, Austria

Landeskrankenhaus/ Univ.-Kliniken Innsbruck

Innsbruck, Austria

HNO, Kopf-und Halschirurgie Ordensklinikum Linz Barmherzigen Schwestern

Linz, Austria

Uniklinikum Salzburg, Univ. Klinik fur Innere Medizin III

Salzburg, Austria

Universitair Ziekenhuis Brussel

Brussels, Belgium

Universitair Ziekenhuis Gent UZ Gent

Ghent, Belgium

CHR de la Citadelle

Liège, Belgium

Fundação PIO XII - Hospital de Amor Barretos

Barretos, Brazil

Oncocentro - Grupo Oncoclinicas

Belo Horizonte, Brazil

Fundacao Universidade de Caxias do Sul - Instituto de Pesquisas em Saude IPS-UCS

Caxias do Sul, Brazil

Hospital Erasto Gaertner

Curitiba, Brazil

Oncosite - Centro de Pesquisa Clinica em Oncologia

Ijuí, Brazil

Hospital Marcio Cunha

Ipatinga, Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre Hospital Santa Rita

Porto Alegre, Brazil

Hospital Mae de Deus

Porto Alegre, Brazil

Hospital Sao Lucas da PUCRS

Porto Alegre, Brazil

Instituto Nacional de Cancer Jose de Alencar Gomes da Silva - INCA

Rio de Janeiro, Brazil

Nucleo de Oncologia da Bahia

Salvador, Brazil

Hospital Sao Rafael

Salvador, Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, Brazil

Instituto do Cancer do Estado de São Paulo

São Paulo, Brazil

IBCC - Instituto Brasileiro de Controle do Cancer

Vila Mariana, Brazil

Cross Cancer Institute

Edmonton, Canada

British Columbia Cancer Agency

Kelowna, Canada

Jewish General Hospital

Montreal, Canada

McGill University Health Centre

Montreal, Canada

Centro de Estudios Clinicos SAGA

Santiago, Chile

Fundación Arturo López Pérez

Santiago, Chile

Fakultni Nemocnice Olomouc

Olomouc, Czechia

Hospital Na Bulovce (Nemocnice na Bulovce)

Prague 8 - Liben, Czechia

CHU de BORDEAUX, Hopital Saint Andre

Bordeaux, France

CHU de Caen Normandie

Caen, France

Centre Georges Francois Leclerc

Dijon, France

Hopital de la Timone

Marseille, France

Institut Curie

Paris, France

Institut Curie, Groupe Hospitalier Paris Saint-Joseph (GHPSJ)

Paris, France

CHU de Tours Hopital Bretonneau

Tours, France

Hospital Gustave Roussy

Villejuif, France

Charite Universitätsklinikum Berlin - Campus Benjamin Franklin

Berlin, Germany

Klinik für HNO-Heilkunde, Kopf- und Hals-Chirurgie

Cologne, Germany

Medizinische Hochschule Hannover (MHH)

Hanover, Germany

Universitaetsklinik Heidelberg

Heidelberg, Germany

St. Josefs-Hospital, Katholisches Krankenhaus Hagen gem. GmbH

Iserlohn, Germany

Universitätsklinikum Leipzig

Leipzig, Germany

UNIVERSITAETSMEDIZIN der Johannes Gutenberg-Universitaet Mainz

Mainz, Germany

Klinikum rechts der Isar der TUM

München, Germany

Univeritätsklinikum Münster

Münster, Germany

Universitaetsmedizin Rostock - Medizinische Klink III (Hamatologie, Onkologie, Palliativmedizin)

Rostock, Germany

Caritas Klinikum Saarbrucken St. Theresia

Saarbrücken, Germany

Medizinische Universitaetsklinik Tuebingen

Tübingen, Germany

Universitätsklinikum Ulm, Klinik für Hals-Nasen- Ohrenheilkunde und Kopf-Halschirurgie

Ulm, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Central Hospital of Northern Pest - Military Hospital

Budapest, Hungary

Rambam Health Clinical

Haifa, Israel

Hadassah Medical Center - Sharett Institute of Oncology

Jerusalem, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

ASST Spedali Civili Brescia

Brescia, Italy

Mater Salutis Hospital AULSS 9 della Regione Veneto

Legnago, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

IRCCS Istituto Europeo di Oncologia

Milan, Italy

Centro de Estudios y Prevención del Cáncer (CEPREC)

Tuxtla Gutiérrez, Region Chiapas, Mexico

Centro Estatal de Cancerologia de Chihuahua

Chihuahua City, Mexico

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Mexico

Cryptex Investigacion SA de CV

Mexico City, Mexico

Consultorio del Dr. Joaquín Gabriel Reinoso Toledo

Monterrey, Mexico

Hospital Universitario "Dr Jose Eleuterio Gonzalez" Centro Universitario contra el Cáncer

Monterrey, Mexico

Oaxaca Site Management Organization S. C.

Oaxaca City, Mexico

Sociedad de Metabolismo y Corazón S.C.

Veracruz, Mexico

Centro de Atencion e Investigacion Clinica en Oncologia (CAICO)

Yucatán, Mexico

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie

Gliwice, Poland

Przychodnia Lekarska KOMED Roman Karaszewski

Konin, Poland

Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

Wroclaw, Poland

Instituto Português de Oncologia de Coimbra Francisco Gentil, E.P.E.

Coimbra, Portugal

IPO Lisboa Francisco Gentil

Lisbon, Portugal

Centro Hospitalar Universitario Lisboa Norte

Lisbon, Portugal

Korea University Anam Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

The Catholic University of Korea St. Vincent's Hospital

Suwon, South Korea

Ajou University Hospital

Suwon, South Korea

Hospital Clinic Barcelona

Barcelona, Spain

Hospital Univ. Dr. Josep Trueta

Girona, Spain

Complejo Hospitalario de Jaen

Jaén, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

Hospital Regional de Malaga

Málaga, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Spain

Hospital La Fe

Valencia, Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Belfast Health and Social Care Trust, Belfast City Hospital

Belfast, United Kingdom

University Hospitals Birmingham, Queen Elizabeth Hospital

Birmingham, United Kingdom

Addenbrooke's Hospital - Cambridge University Hospitals

Cambridge, United Kingdom

Velindre Cancer Centre

Cardiff, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Leeds Teaching Hospitals NHS Trust (St James's University Hospital)

Leeds, United Kingdom

The Clatterbridge Cancer Centre

Liverpool, United Kingdom

University College London Hospitals

London, United Kingdom

Guy's Cancer Centre, Guy's Hospital

London, United Kingdom

The Royal Marsden Hospital NHS Foundation Trust - Fulham Road

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Oxford Cancer Centre

Oxford, United Kingdom

Royal Preston Hospital Lancashire Teaching Hospitals NHS Foundation Trust

Preston, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Mount Vernon Cancer Centre, East and North Hertfordshire NHS Trust

Stevenage, United Kingdom

The Royal Marsden Hospital - Sutton

Sutton, United Kingdom

Torbay Hospital - South Devon Healthcare NHS Foundation Trust

Torquay, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (138)