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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

January 7, 2021

Primary Completion Date

April 30, 2029

Study Completion Date

April 30, 2029

Conditions
Unresectable Head and Neck Squamous Cell CarcinomaMetastatic Head and Neck CancerRecurrent Head and Neck Cancer
Interventions
BIOLOGICAL

BNT113

IV injection

BIOLOGICAL

Pembrolizumab

IV infusion

Trial Locations (188)

1062

RECRUITING

Central Hospital of Northern Pest - Military Hospital, Budapest

1090

RECRUITING

Universitair Ziekenhuis Brussel, Brussels

1145

WITHDRAWN

Uzsoki Utcai Korhaz Onkologiai Osztaly, Budapest

1280

RECRUITING

Hospital Britanico de Buenos Aires, Ciudad de Buenos Aires

2000

RECRUITING

Instituto de Oncologia de Rosario, Rosario

RECRUITING

Sanatorio Britanico, Rosario

2065

ACTIVE_NOT_RECRUITING

Royal North Shore Hospital, Saint Leonards

2200

WITHDRAWN

Bankstown-Lidcombe Hospital, Bankstown

2450

WITHDRAWN

Coffs Harbour Hospital, Coffs Harbour

2500

ACTIVE_NOT_RECRUITING

Southern Medical Day Care Centre, Wollongong

2700

RECRUITING

Centro de Investigacion Pergamino SA - Clinica Pergamino, Pergamino

4000

RECRUITING

CAIPO Centro para la Atencion Integral del Paciente Oncologico, San Miguel de Tucumán

RECRUITING

CHR de la Citadelle, Liège

4010

RECRUITING

HNO, Kopf-und Halschirurgie Ordensklinikum Linz Barmherzigen Schwestern, Linz

4032

WITHDRAWN

DEKK Onkologiai Klinika, Debrecen

4224

ACTIVE_NOT_RECRUITING

John Flynn Private Hospital, Tugun

5000

ACTIVE_NOT_RECRUITING

Cancer Research SA, Adelaide

5020

RECRUITING

Uniklinikum Salzburg, Univ. Klinik fur Innere Medizin III, Salzburg

5042

ACTIVE_NOT_RECRUITING

Flinders Medical Centre, Bedford Park

5300

RECRUITING

Centro Oncologico Riojano Integral, La Rioja

6020

RECRUITING

Landeskrankenhaus/ Univ.-Kliniken Innsbruck, Innsbruck

8036

RECRUITING

LKH - Univ. Klinikum Graz, Graz

8500

WITHDRAWN

Clinica Viedma, Viedma

8900

RECRUITING

Zala Megyei S. Rafael Korhaz, Zalaegerszeg

9000

RECRUITING

Universitair Ziekenhuis Gent UZ Gent, Ghent

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

10467

RECRUITING

Montefiore Medical Center, The Bronx

11217

RECRUITING

Taipei Veterans General Hospital, Taipei

13005

RECRUITING

Hopital de la Timone, Marseille

13353

RECRUITING

Charite Universitätsklinikum Berlin - Campus Benjamin Franklin, Berlin

14033

RECRUITING

CHU de Caen Normandie, Caen

16247

RECRUITING

The Catholic University of Korea St. Vincent's Hospital, Suwon

16499

RECRUITING

Ajou University Hospital, Suwon

17007

RECRUITING

Hospital Univ. Dr. Josep Trueta, Girona

18057

RECRUITING

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

20052

RECRUITING

The George Washington Cancer Center, Washington D.C.

20132

RECRUITING

IRCCS Ospedale San Raffaele, Milan

20141

RECRUITING

IRCCS Istituto Europeo di Oncologia, Milan

21079

ACTIVE_NOT_RECRUITING

Centre Georges Francois Leclerc, Dijon

22030

WITHDRAWN

Trakya University, Edirne

23007

RECRUITING

Complejo Hospitalario de Jaen, Jaén

25123

SUSPENDED

ASST Spedali Civili Brescia, Brescia

28027

RECRUITING

Clinica Universidad de Navarra - Madrid (CUN-M), Madrid

28040

RECRUITING

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28046

WITHDRAWN

Hospital Universitario La Paz, Madrid

28100

WITHDRAWN

A.O.U. Maggiore della Carita, Novara

28222

RECRUITING

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

29010

RECRUITING

Hospital Regional de Malaga, Málaga

29038

ACTIVE_NOT_RECRUITING

Centro de Estudios y Prevención del Cáncer (CEPREC), Tuxtla Gutiérrez

30322

RECRUITING

Winship Cancer Institute, Atlanta

30607

WITHDRAWN

University Cancer and Blood Center, Athens

30625

RECRUITING

Medizinische Hochschule Hannover (MHH), Hanover

31000

ACTIVE_NOT_RECRUITING

Centro Estatal de Cancerologia de Chihuahua, Chihuahua City

31008

RECRUITING

Clinica Universidad de Navarra - Pamplona (CUN-P), Pamplona

33075

RECRUITING

CHU de BORDEAUX, Hopital Saint Andre, Bordeaux

33100

WITHDRAWN

Azienda Sanitaria Universitaria Integrata Friuli Centrale - Presidio ospedaliero di Udine, Udine

33136

RECRUITING

University of Miami Miller School of Medicine, Miami

34093

WITHDRAWN

Istanbul Universitesi Onkoloji Enstitusu, Istanbul

34098

WITHDRAWN

Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, Istanbul

34214

WITHDRAWN

Medipol Mega Universite Hastanesi, Istanbul

34722

WITHDRAWN

Istanbul Medeniyet University Medical Faculty, Istanbul

35015

RECRUITING

Chungnam National University Hospital, Daejeon

35040

WITHDRAWN

Ege Universitesi Tip Fakultesi Hastanesi - Tulay Aktas Onkoloji Hastanesi, Izmir

35365

RECRUITING

Konyang University Hospital, Daejeon

35575

WITHDRAWN

Medical Park - Izmir Hastanesi, Izmir

37044

RECRUITING

CHU de Tours Hopital Bretonneau, Tours

37045

RECRUITING

Mater Salutis Hospital AULSS 9 della Regione Veneto, Legnago

40241

RECRUITING

Norton Cancer Institute, Louisville

40878

RECRUITING

Kath. Marien Krankenhaus gGmbH, Hamburg

44277

ACTIVE_NOT_RECRUITING

Hopital Prive du Confluent, Nantes

44280

ACTIVE_NOT_RECRUITING

Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara

WITHDRAWN

Inonu Universitesi - Turgut Ozal Tip Merkezi, Malatya

45219

RECRUITING

University of Cincinnati Cancer Center, Cincinnati

46026

RECRUITING

Hospital La Fe, Valencia

48149

RECRUITING

Univeritätsklinikum Münster, Münster

49100

RECRUITING

Hadassah Medical Center - Sharett Institute of Oncology, Jerusalem

50006

RECRUITING

Changhua Christian Hospital, Changhua

50009

WITHDRAWN

Hospital Miguel Servet, Zaragoza

50544

RECRUITING

Chang Bing Show Chwan Memorial Hospital, Changhua

50937

RECRUITING

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

53100

RECRUITING

Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte, Siena

55131

RECRUITING

UNIVERSITAETSMEDIZIN der Johannes Gutenberg-Universitaet Mainz, Mainz

58128

RECRUITING

Chonnam National University Hwasun Hospital, Hwasun

60488

WITHDRAWN

Krankenhaus Nordwest GmbH, Frankfurt am Main

64320

ACTIVE_NOT_RECRUITING

Consultorio del Dr. Joaquín Gabriel Reinoso Toledo, Monterrey

64460

ACTIVE_NOT_RECRUITING

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

66113

RECRUITING

Caritas Klinikum Saarbrucken St. Theresia, Saarbrücken

68000

ACTIVE_NOT_RECRUITING

Oaxaca Site Management Organization S. C., Oaxaca City

69124

RECRUITING

Universitaetsklinik Heidelberg, Heidelberg

72000

WITHDRAWN

Clinique Victor Hugo, Le Mans

72076

RECRUITING

Medizinische Universitaetsklinik Tuebingen, Tübingen

75005

RECRUITING

Institut Curie, Paris

75014

ACTIVE_NOT_RECRUITING

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

77030

RECRUITING

MD Anderson Cancer Center, Houston

80147

WITHDRAWN

Ospedale del Mare, Napoli

80708

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

81675

RECRUITING

Klinikum rechts der Isar der TUM, München

87131

RECRUITING

The University of New Mexico Comprehensive Cancer Center, Albuquerque

90027

RECRUITING

California Research Institute, Los Angeles

90095

RECRUITING

UCLA Cancer Care, Los Angeles

91900

ACTIVE_NOT_RECRUITING

Sociedad de Metabolismo y Corazón S.C., Veracruz

92300

ACTIVE_NOT_RECRUITING

Institut de Radiothérapie Hartmann, GCS CCConcorde, Levallois-Perret

94304

COMPLETED

Stanford Cancer Institute, Palo Alto

94800

RECRUITING

Hospital Gustave Roussy, Villejuif

97080

RECRUITING

Universitaetsklinikum Wuerzburg, Würzburg

97134

ACTIVE_NOT_RECRUITING

Centro de Atencion e Investigacion Clinica en Oncologia (CAICO), Yucatán

97213

WITHDRAWN

Providence Cancer Institute, Portland

98405

WITHDRAWN

MultiCare Regional Cancer Center, Tacoma

100225

RECRUITING

National Taiwan University Hospital, Taipei

407219

RECRUITING

Taichung Veterans General Hospital, Taichung

833401

RECRUITING

Chang Gung Memorial Hospital-Kaohsiung Branch, Kaohsiung City

3109601

RECRUITING

Rambam Health Clinical, Haifa

4800827

WITHDRAWN

James Lind Centro de Investigación del Cáncer, Temuco

4941492

RECRUITING

Rabin Medical Center, Petah Tikva

6423906

RECRUITING

Tel Aviv Sourasky Medical Center, Tel Aviv

7500653

RECRUITING

Centro de Estudios Clinicos SAGA, Santiago

7500921

RECRUITING

Fundación Arturo López Pérez, Santiago

06511

RECRUITING

Yale University, New Haven

02111

RECRUITING

Tufts Medical Center, Boston

B1884BBF

RECRUITING

Centro de Oncología e Investigación Buenos Aires COIBA, Berazategui

X500AA1

RECRUITING

Instituto de Oncologia de Cordoba, Córdoba

VIC 3065

ACTIVE_NOT_RECRUITING

St Vincent's Hospital, Fitzroy

14784-400

ACTIVE_NOT_RECRUITING

Fundação PIO XII - Hospital de Amor Barretos, Barretos

95070-560

ACTIVE_NOT_RECRUITING

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

81520-060

ACTIVE_NOT_RECRUITING

Hospital Erasto Gaertner, Curitiba

98700-000

ACTIVE_NOT_RECRUITING

Oncosite - Centro de Pesquisa Clinica em Oncologia, Ijuí

35162-189

ACTIVE_NOT_RECRUITING

Hospital Marcio Cunha, Ipatinga

90050-170

ACTIVE_NOT_RECRUITING

Irmandade Santa Casa de Misericordia de Porto Alegre Hospital Santa Rita, Porto Alegre

90110-270

ACTIVE_NOT_RECRUITING

Hospital Mae de Deus, Porto Alegre

90610-000

ACTIVE_NOT_RECRUITING

Hospital Sao Lucas da PUCRS, Porto Alegre

20231-050

ACTIVE_NOT_RECRUITING

Instituto Nacional de Cancer Jose de Alencar Gomes da Silva - INCA, Rio de Janeiro

41253-190

ACTIVE_NOT_RECRUITING

Hospital Sao Rafael, Salvador

15090-000

ACTIVE_NOT_RECRUITING

Hospital de Base de Sao Jose do Rio Preto, São José do Rio Preto

01246-000

ACTIVE_NOT_RECRUITING

Instituto do Cancer do Estado de São Paulo, São Paulo

04014-002

ACTIVE_NOT_RECRUITING

IBCC - Instituto Brasileiro de Controle do Cancer, Vila Mariana

T6G 1Z2

RECRUITING

Cross Cancer Institute, Edmonton

V1Y 5L3

RECRUITING

British Columbia Cancer Agency, Kelowna

H3T 1E2

RECRUITING

Jewish General Hospital, Montreal

H4A 3J1

RECRUITING

McGill University Health Centre, Montreal

M5G 2C1

WITHDRAWN

Princess Margaret Cancer Centre, Toronto

779 00

RECRUITING

Fakultni Nemocnice Olomouc, Olomouc

180 00

RECRUITING

Hospital Na Bulovce (Nemocnice na Bulovce), Prague 8 - Liben

07548

WITHDRAWN

SRH Wald-Klinikum Gera GmbH, Hamburg

04103

RECRUITING

Universitätsklinikum Leipzig, Leipzig

06100

ACTIVE_NOT_RECRUITING

Cryptex Investigacion SA de CV, Mexico City

80-214

RECRUITING

Uniwersyteckie Centrum Kliniczne, Gdansk

81-519

RECRUITING

Szpitale Pomorskie Sp.zo.o, Gdynia

44-102

RECRUITING

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie, Gliwice

62-500

RECRUITING

Przychodnia Lekarska KOMED Roman Karaszewski, Konin

30-510

WITHDRAWN

MCM Pratia Krakow, Krakow

60-185

WITHDRAWN

Centrum Medyczne Pratia Poznań, Poznan

50-981

RECRUITING

Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ, Wroclaw

4710-243

RECRUITING

Centro Clinico Academico, Braga

3000-075

RECRUITING

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

4434-502

RECRUITING

Centro Hospitalar de Vila Nova de Gaia/Espinho, Gaia

1099-023

RECRUITING

IPO Lisboa Francisco Gentil, Lisbon

1649-028

RECRUITING

Centro Hospitalar Universitario Lisboa Norte, Lisbon

4200-072

RECRUITING

Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E, Porto

02841

RECRUITING

Korea University Anam Hospital, Seoul

03722

RECRUITING

Severance Hospital, Yonsei University Health System, Seoul

06591

RECRUITING

The Catholic University of Korea, Seoul ST. Mary's Hospital, Seoul

08036

RECRUITING

Hospital Clinic Barcelona, Barcelona

07120

RECRUITING

Hospital Universitario Son Espases, Palma de Mallorca

413 45

WITHDRAWN

Sahlgrenska University Hospital, Gothenburg

221 85

WITHDRAWN

Skane University Hospital, Lund

901 87

RECRUITING

Norrlands University Hospital, Umeå

01140

WITHDRAWN

Medical Park Seyhan Hospital, Adana

06230

ACTIVE_NOT_RECRUITING

Hacettepe University Cancer Institute, Ankara

06800

WITHDRAWN

Ankara Bilkent Sehir Hastanesi, Ankara

01250

WITHDRAWN

Baskent University, Yüreğir

AB25 2ZN

RECRUITING

Aberdeen Royal Infirmary, Aberdeen

BT9 7AB

RECRUITING

Belfast Health and Social Care Trust, Belfast City Hospital, Belfast

B15 2TH

RECRUITING

University Hospitals Birmingham, Queen Elizabeth Hospital, Birmingham

CB2 0QQ

RECRUITING

Addenbrooke's Hospital - Cambridge University Hospitals, Cambridge

CF14 2TL

RECRUITING

Velindre Cancer Centre, Cardiff

G12 0YN

RECRUITING

Beatson West of Scotland Cancer Centre, Glasgow

LS9 7TF

RECRUITING

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

L7 8YA

RECRUITING

The Clatterbridge Cancer Centre, Liverpool

NW 12 PG

RECRUITING

University College London Hospitals, London

SE1 9RT

RECRUITING

Guy's Cancer Centre, Guy's Hospital, London

SW3 6JJ

RECRUITING

The Royal Marsden Hospital NHS Foundation Trust - Fulham Road, London

NG5 1PB

RECRUITING

Nottingham University Hospitals NHS Trust, Nottingham

OX3 7LE

RECRUITING

Oxford Cancer Centre, Oxford

PR2 9HT

RECRUITING

Royal Preston Hospital Lancashire Teaching Hospitals NHS Foundation Trust, Preston

SO16 6YD

RECRUITING

University Hospital Southampton NHS Foundation Trust, Southampton

SG1 4AB

RECRUITING

Mount Vernon Cancer Centre, East and North Hertfordshire NHS Trust, Stevenage

SM2 5PT

RECRUITING

The Royal Marsden Hospital - Sutton, Sutton

TQ2 7AA

RECRUITING

Torbay Hospital - South Devon Healthcare NHS Foundation Trust, Torquay

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BioNTech SE

INDUSTRY