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
NCT ID: NCT04534205
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
350 participants
INTERVENTIONAL
2021-01-07
2029-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
BNT113
IV injection
Pembrolizumab
IV infusion
Part B (Randomized phase) - BNT113 + Pembrolizumab
BNT113 in combination with pembrolizumab.
BNT113
IV injection
Pembrolizumab
IV infusion
Part B (Randomized phase) - Pembrolizumab monotherapy
Pembrolizumab monotherapy.
Pembrolizumab
IV infusion
Interventions
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BNT113
IV injection
Pembrolizumab
IV infusion
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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BioNTech SE
INDUSTRY
Responsible Party
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Principal Investigators
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BioNTech Responsible Person
Role: STUDY_DIRECTOR
BioNTech SE
Locations
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California Research Institute
Los Angeles, California, United States
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
University Cancer and Blood Center
Athens, Georgia, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
The University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 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
Providence Cancer Institute
Portland, Oregon, United States
MD Anderson Cancer Center
Houston, Texas, United States
MultiCare Regional Cancer Center
Tacoma, Washington, United States
Centro de Oncología e Investigación Buenos Aires COIBA
Berazategui, , Argentina
Hospital Britanico de Buenos Aires
Ciudad de Buenos Aires, , 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
Clinica Viedma
Viedma, , Argentina
Cancer Research SA
Adelaide, , Australia
Bankstown-Lidcombe Hospital
Bankstown, , Australia
Flinders Medical Centre
Bedford Park, , Australia
Coffs Harbour Hospital
Coffs Harbour, , 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
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
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
Princess Margaret Cancer Centre
Toronto, , Canada
Centro de Estudios Clinicos SAGA
Santiago, , Chile
Fundación Arturo López Pérez
Santiago, , Chile
James Lind Centro de Investigación del Cáncer
Temuco, , 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
Clinique Victor Hugo
Le Mans, , France
Institut de Radiothérapie Hartmann, GCS CCConcorde
Levallois-Perret, , France
Hopital de la Timone
Marseille, , France
Hopital Prive du Confluent
Nantes, , 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
Krankenhaus Nordwest GmbH
Frankfurt am Main, , Germany
SRH Wald-Klinikum Gera GmbH
Hamburg, , Germany
Kath. Marien Krankenhaus gGmbH
Hamburg, , Germany
Medizinische Hochschule Hannover (MHH)
Hanover, , Germany
Universitaetsklinik Heidelberg
Heidelberg, , 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
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Central Hospital of Northern Pest - Military Hospital
Budapest, , Hungary
Uzsoki Utcai Korhaz Onkologiai Osztaly
Budapest, , Hungary
DEKK Onkologiai Klinika
Debrecen, , Hungary
Zala Megyei S. Rafael Korhaz
Zalaegerszeg, , Hungary
Rambam Health Clinical
Haifa, , Israel
Hadassah Medical Center - Sharett Institute of Oncology
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , 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
Ospedale del Mare
Napoli, , Italy
A.O.U. Maggiore della Carita
Novara, , Italy
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, , Italy
Azienda Sanitaria Universitaria Integrata Friuli Centrale - Presidio ospedaliero di Udine
Udine, , 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
Szpitale Pomorskie Sp.zo.o
Gdynia, , Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie
Gliwice, , Poland
Przychodnia Lekarska KOMED Roman Karaszewski
Konin, , Poland
MCM Pratia Krakow
Krakow, , Poland
Centrum Medyczne Pratia Poznań
Poznan, , Poland
Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
Wroclaw, , Poland
Centro Clinico Academico
Braga, , Portugal
Instituto Português de Oncologia de Coimbra Francisco Gentil, E.P.E.
Coimbra, , Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho
Gaia, , Portugal
IPO Lisboa Francisco Gentil
Lisbon, , Portugal
Centro Hospitalar Universitario Lisboa Norte
Lisbon, , Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E
Porto, , Portugal
Chungnam National University Hospital
Daejeon, , South Korea
Konyang University Hospital
Daejeon, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
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
Clinica Universidad de Navarra - Madrid (CUN-M)
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Hospital Regional de Malaga
Málaga, , Spain
Hospital Universitario Son Espases
Palma de Mallorca, , Spain
Clinica Universidad de Navarra - Pamplona (CUN-P)
Pamplona, , Spain
Hospital La Fe
Valencia, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
Sahlgrenska University Hospital
Gothenburg, , Sweden
Skane University Hospital
Lund, , Sweden
Norrlands University Hospital
Umeå, , Sweden
Changhua Christian Hospital
Changhua, , Taiwan
Chang Bing Show Chwan Memorial Hospital
Changhua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital-Kaohsiung Branch
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Medical Park Seyhan Hospital
Adana, , Turkey (Türkiye)
Hacettepe University Cancer Institute
Ankara, , Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, , Turkey (Türkiye)
Trakya University
Edirne, , Turkey (Türkiye)
Istanbul Universitesi Onkoloji Enstitusu
Istanbul, , Turkey (Türkiye)
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Medipol Mega Universite Hastanesi
Istanbul, , Turkey (Türkiye)
Istanbul Medeniyet University Medical Faculty
Istanbul, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi - Tulay Aktas Onkoloji Hastanesi
Izmir, , Turkey (Türkiye)
Medical Park - Izmir Hastanesi
Izmir, , Turkey (Türkiye)
Inonu Universitesi - Turgut Ozal Tip Merkezi
Malatya, , Turkey (Türkiye)
Baskent University
Yüreğir, , Turkey (Türkiye)
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
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
Countries
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Central Contacts
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BioNTech clinical trials patient information
Role: CONTACT
Phone: +49 6131 9084
Email: [email protected]
Other Identifiers
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2020-001400-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-512671-12-00
Identifier Type: CTIS
Identifier Source: secondary_id
BNT113-01
Identifier Type: -
Identifier Source: org_study_id