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

NCT04534205 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: BNT113-012020-001400-412024-512671-12-00
• Study Type: interventional
• Target: 350
• Locations: 22 countries
• Sites: 189

Brief 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

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

Keywords

Cancer vaccine; RNA vaccine; HNSCC; BNT113; Pembrolizumab; HPV16; Metastatic; Unresectable; Recurrent; Head and neck; mRNA vaccine; HPV-positive; Head and neck cancer

Outcome Measures

Primary Outcomes (3)

• Part A - Occurrence of treatment-emergent adverse event (TEAE) - BNT113 in combination with pembrolizumab

  TEAE assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) including Grade ≥3, serious, and fatal TEAEs, by relationship.

  up to 27 months

• Part B - Overall survival (OS)

  OS defined as the time from randomization to death from any cause.

  up to 48 months

• Part B - Progression-free survival (PFS)

  PFS defined as the time from randomization to the first objective tumor progression (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\] assessed by the blinded independent central review \[BICR\]), or death from any cause, whichever occurs first.

  up to 48 months

Secondary Outcomes (8)

• Part A and B - Overall response rate (ORR)

  up to 48 months

• Part A and B - Duration of response (DOR)

  up to 48 months

• Part A - Disease control rate (DCR)

  up to 48 months

• Part B - Progression free survival (PFS)

  up to 48 months

• Part B - PFS rate at 6 months

  from randomization until 6 months after randomization

Study Arms (3)

Part A (Safety Run-In) - BNT113 + Pembrolizumab

EXPERIMENTAL

Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab.

Biological: BNT113; Biological: Pembrolizumab

Part B (Randomized phase) - BNT113 + Pembrolizumab

EXPERIMENTAL

BNT113 in combination with pembrolizumab.

Biological: BNT113; Biological: Pembrolizumab

Part B (Randomized phase) - Pembrolizumab monotherapy

ACTIVE COMPARATOR

Pembrolizumab monotherapy.

Biological: Pembrolizumab

Interventions

Pembrolizumab BIOLOGICAL

IV infusion

Part A (Safety Run-In) - BNT113 + Pembrolizumab; Part B (Randomized phase) - BNT113 + Pembrolizumab; Part B (Randomized phase) - Pembrolizumab monotherapy

BNT113 BIOLOGICAL

IV injection

Part A (Safety Run-In) - BNT113 + Pembrolizumab; Part B (Randomized phase) - BNT113 + Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• 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.
• Prior treatment with live attenuated vaccines within 4 weeks before the first dose of BNT113.
• 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.
• 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.

Sponsors & Collaborators

• BioNTech SE: lead

Study Sites (193)

California Research Institute

Los Angeles, California, 90027, United States

WITHDRAWN

UCLA Cancer Care

Los Angeles, California, 90095, United States

RECRUITING

Stanford Cancer Institute

Palo Alto, California, 94304, United States

COMPLETED

Yale University

New Haven, Connecticut, 06511, United States

RECRUITING

The George Washington Cancer Center

Washington D.C., District of Columbia, 20052, United States

RECRUITING

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

RECRUITING

University Cancer and Blood Center

Athens, Georgia, 30607, United States

WITHDRAWN

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Norton Cancer Institute

Louisville, Kentucky, 40241, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

The University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87131, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

University of Cincinnati Cancer Center

Cincinnati, Ohio, 45219, United States

RECRUITING

Providence Cancer Institute

Portland, Oregon, 97213, United States

WITHDRAWN

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MultiCare Regional Cancer Center

Tacoma, Washington, 98405, United States

WITHDRAWN

Centro de Oncología e Investigación Buenos Aires COIBA

Berazategui, B1884BBF, Argentina

RECRUITING

Hospital Britanico de Buenos Aires

Ciudad de Buenos Aires, 1280, Argentina

WITHDRAWN

Instituto de Oncologia de Cordoba

Córdoba, X500AA1, Argentina

RECRUITING

Centro Oncologico Riojano Integral

La Rioja, 5300, Argentina

RECRUITING

Centro de Investigacion Pergamino SA - Clinica Pergamino

Pergamino, 2700, Argentina

RECRUITING

Instituto de Oncologia de Rosario

Rosario, 2000, Argentina

RECRUITING

Sanatorio Britanico

Rosario, 2000, Argentina

RECRUITING

CAIPO Centro para la Atencion Integral del Paciente Oncologico

San Miguel de Tucumán, 4000, Argentina

RECRUITING

Clinica Viedma

Viedma, 8500, Argentina

WITHDRAWN

Cancer Research SA

Adelaide, 5000, Australia

RECRUITING

Bankstown-Lidcombe Hospital

Bankstown, 2200, Australia

WITHDRAWN

Flinders Medical Centre

Bedford Park, 5042, Australia

RECRUITING

Coffs Harbour Hospital

Coffs Harbour, 2450, Australia

WITHDRAWN

St Vincent's Hospital

Fitzroy, VIC 3065, Australia

RECRUITING

Royal North Shore Hospital

Saint Leonards, 2065, Australia

RECRUITING

John Flynn Private Hospital

Tugun, 4224, Australia

RECRUITING

Southern Medical Day Care Centre

Wollongong, 2500, Australia

RECRUITING

LKH - Univ. Klinikum Graz

Graz, 8036, Austria

RECRUITING

Landeskrankenhaus/ Univ.-Kliniken Innsbruck

Innsbruck, 6020, Austria

RECRUITING

HNO, Kopf-und Halschirurgie Ordensklinikum Linz Barmherzigen Schwestern

Linz, 4010, Austria

RECRUITING

Uniklinikum Salzburg, Univ. Klinik fur Innere Medizin III

Salzburg, 5020, Austria

RECRUITING

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

RECRUITING

Universitair Ziekenhuis Gent UZ Gent

Ghent, 9000, Belgium

RECRUITING

CHR de la Citadelle

Liège, 4000, Belgium

RECRUITING

Fundação PIO XII - Hospital de Amor Barretos

Barretos, 14784-400, Brazil

RECRUITING

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

Caxias do Sul, 95070-560, Brazil

RECRUITING

Hospital Erasto Gaertner

Curitiba, 81520-060, Brazil

RECRUITING

Oncosite - Centro de Pesquisa Clinica em Oncologia

Ijuí, 98700-000, Brazil

RECRUITING

Hospital Marcio Cunha

Ipatinga, 35162-189, Brazil

RECRUITING

Irmandade Santa Casa de Misericordia de Porto Alegre Hospital Santa Rita

Porto Alegre, 90050-170, Brazil

RECRUITING

Hospital Mae de Deus

Porto Alegre, 90110-270, Brazil

RECRUITING

Hospital Sao Lucas da PUCRS

Porto Alegre, 90610-000, Brazil

RECRUITING

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

Rio de Janeiro, 20231-050, Brazil

RECRUITING

Nucleo de Oncologia da Bahia

Salvador, 40170-070, Brazil

RECRUITING

Hospital Sao Rafael

Salvador, 41253-190, Brazil

RECRUITING

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, 15090-000, Brazil

RECRUITING

Instituto do Cancer do Estado de São Paulo

São Paulo, 01246-000, Brazil

RECRUITING

IBCC - Instituto Brasileiro de Controle do Cancer

Vila Mariana, 04014-002, Brazil

RECRUITING

Cross Cancer Institute

Edmonton, T6G 1Z2, Canada

RECRUITING

British Columbia Cancer Agency

Kelowna, V1Y 5L3, Canada

RECRUITING

Jewish General Hospital

Montreal, H3T 1E2, Canada

RECRUITING

McGill University Health Centre

Montreal, H4A 3J1, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, M5G 2C1, Canada

WITHDRAWN

Centro de Estudios Clinicos SAGA

Santiago, 7500653, Chile

RECRUITING

Fundación Arturo López Pérez

Santiago, 7500921, Chile

RECRUITING

James Lind Centro de Investigación del Cáncer

Temuco, 4800827, Chile

WITHDRAWN

Fakultni Nemocnice Olomouc

Olomouc, 779 00, Czechia

RECRUITING

Hospital Na Bulovce (Nemocnice na Bulovce)

Prague 8 - Liben, 180 00, Czechia

RECRUITING

CHU de BORDEAUX, Hopital Saint Andre

Bordeaux, 33075, France

RECRUITING

CHU de Caen Normandie

Caen, 14033, France

RECRUITING

Centre Georges Francois Leclerc

Dijon, 21079, France

ACTIVE NOT RECRUITING

Clinique Victor Hugo

Le Mans, 72000, France

WITHDRAWN

Institut de Radiothérapie Hartmann, GCS CCConcorde

Levallois-Perret, 92300, France

WITHDRAWN

Hopital de la Timone

Marseille, 13005, France

RECRUITING

Hopital Prive du Confluent

Nantes, 44277, France

WITHDRAWN

Institut Curie

Paris, 75005, France

RECRUITING

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

Paris, 75014, France

ACTIVE NOT RECRUITING

CHU de Tours Hopital Bretonneau

Tours, 37044, France

RECRUITING

Hospital Gustave Roussy

Villejuif, 94800, France

RECRUITING

Charite Universitätsklinikum Berlin - Campus Benjamin Franklin

Berlin, 13353, Germany

RECRUITING

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

Cologne, 50937, Germany

RECRUITING

Krankenhaus Nordwest GmbH

Frankfurt am Main, 60488, Germany

WITHDRAWN

SRH Wald-Klinikum Gera GmbH

Hamburg, 07548, Germany

WITHDRAWN

Kath. Marien Krankenhaus gGmbH

Hamburg, 40878, Germany

WITHDRAWN

Medizinische Hochschule Hannover (MHH)

Hanover, 30625, Germany

RECRUITING

Universitaetsklinik Heidelberg

Heidelberg, 69124, Germany

RECRUITING

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

Iserlohn, 58638, Germany

RECRUITING

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

RECRUITING

UNIVERSITAETSMEDIZIN der Johannes Gutenberg-Universitaet Mainz

Mainz, 55131, Germany

RECRUITING

Klinikum rechts der Isar der TUM

München, 81675, Germany

RECRUITING

Univeritätsklinikum Münster

Münster, 48149, Germany

RECRUITING

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

Rostock, 18057, Germany

RECRUITING

Caritas Klinikum Saarbrucken St. Theresia

Saarbrücken, 66113, Germany

RECRUITING

Medizinische Universitaetsklinik Tuebingen

Tübingen, 72076, Germany

RECRUITING

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

Ulm, 89081, Germany

RECRUITING

Universitaetsklinikum Wuerzburg

Würzburg, 97080, Germany

RECRUITING

Central Hospital of Northern Pest - Military Hospital

Budapest, 1062, Hungary

RECRUITING

Uzsoki Utcai Korhaz Onkologiai Osztaly

Budapest, 1145, Hungary

WITHDRAWN

DEKK Onkologiai Klinika

Debrecen, 4032, Hungary

WITHDRAWN

Zala Megyei S. Rafael Korhaz

Zalaegerszeg, 8900, Hungary

RECRUITING

Rambam Health Clinical

Haifa, 3109601, Israel

RECRUITING

Hadassah Medical Center - Sharett Institute of Oncology

Jerusalem, 49100, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, 4941492, Israel

RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

ASST Spedali Civili Brescia

Brescia, 25123, Italy

RECRUITING

Mater Salutis Hospital AULSS 9 della Regione Veneto

Legnago, 37045, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

IRCCS Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

Ospedale del Mare

Naples, 80147, Italy

WITHDRAWN

A.O.U. Maggiore della Carita

Novara, 28100, Italy

WITHDRAWN

Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

Siena, 53100, Italy

RECRUITING

Azienda Sanitaria Universitaria Integrata Friuli Centrale - Presidio ospedaliero di Udine

Udine, 33100, Italy

WITHDRAWN

Centro de Estudios y Prevención del Cáncer (CEPREC)

Tuxtla Gutiérrez, Region Chiapas, 29038, Mexico

RECRUITING

Centro Estatal de Cancerologia de Chihuahua

Chihuahua City, 31000, Mexico

RECRUITING

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, 44280, Mexico

RECRUITING

Cryptex Investigacion SA de CV

Mexico City, 06100, Mexico

RECRUITING

Consultorio del Dr. Joaquín Gabriel Reinoso Toledo

Monterrey, 64320, Mexico

RECRUITING

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

Monterrey, 64460, Mexico

RECRUITING

Oaxaca Site Management Organization S. C.

Oaxaca City, 68000, Mexico

RECRUITING

Sociedad de Metabolismo y Corazón S.C.

Veracruz, 91900, Mexico

RECRUITING

Centro de Atencion e Investigacion Clinica en Oncologia (CAICO)

Yucatán, 97134, Mexico

RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

RECRUITING

Szpitale Pomorskie Sp.zo.o

Gdynia, 81-519, Poland

WITHDRAWN

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie

Gliwice, 44-102, Poland

RECRUITING

Przychodnia Lekarska KOMED Roman Karaszewski

Konin, 62-500, Poland

RECRUITING

MCM Pratia Krakow

Krakow, 30-510, Poland

WITHDRAWN

Centrum Medyczne Pratia Poznań

Poznan, 60-185, Poland

WITHDRAWN

Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

Wroclaw, 50-981, Poland

RECRUITING

Centro Clinico Academico

Braga, 4710-243, Portugal

WITHDRAWN

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

Coimbra, 3000-075, Portugal

RECRUITING

Centro Hospitalar de Vila Nova de Gaia/Espinho

Gaia, 4434-502, Portugal

WITHDRAWN

IPO Lisboa Francisco Gentil

Lisbon, 1099-023, Portugal

RECRUITING

Centro Hospitalar Universitario Lisboa Norte

Lisbon, 1649-028, Portugal

RECRUITING

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

Porto, 4200-072, Portugal

RECRUITING

Chungnam National University Hospital

Daejeon, 35015, South Korea

WITHDRAWN

Konyang University Hospital

Daejeon, 35365, South Korea

RECRUITING

Chonnam National University Hwasun Hospital

Hwasun, 58128, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, 02841, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

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

Seoul, 06591, South Korea

RECRUITING

The Catholic University of Korea St. Vincent's Hospital

Suwon, 16247, South Korea

RECRUITING

Ajou University Hospital

Suwon, 16499, South Korea

RECRUITING

Hospital Clinic Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital Univ. Dr. Josep Trueta

Girona, 17007, Spain

RECRUITING

Complejo Hospitalario de Jaen

Jaén, 23007, Spain

RECRUITING

Clinica Universidad de Navarra - Madrid (CUN-M)

Madrid, 28027, Spain

RECRUITING

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

WITHDRAWN

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, 28222, Spain

RECRUITING

Hospital Regional de Malaga

Málaga, 29010, Spain

RECRUITING

Hospital Universitario Son Espases

Palma de Mallorca, 07120, Spain

RECRUITING

Clinica Universidad de Navarra - Pamplona (CUN-P)

Pamplona, 31008, Spain

RECRUITING

Hospital La Fe

Valencia, 46026, Spain

RECRUITING

Hospital Miguel Servet

Zaragoza, 50009, Spain

WITHDRAWN

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

WITHDRAWN

Skane University Hospital

Lund, 221 85, Sweden

WITHDRAWN

Norrlands University Hospital

Umeå, 901 87, Sweden

WITHDRAWN

Changhua Christian Hospital

Changhua, 50006, Taiwan

RECRUITING

Chang Bing Show Chwan Memorial Hospital

Changhua, 50544, Taiwan

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80708, Taiwan

RECRUITING

Chang Gung Memorial Hospital-Kaohsiung Branch

Kaohsiung City, 833401, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Medical Park Seyhan Hospital

Adana, 01140, Turkey (Türkiye)

WITHDRAWN

Hacettepe University Cancer Institute

Ankara, 06230, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Ankara Bilkent Sehir Hastanesi

Ankara, 06800, Turkey (Türkiye)

WITHDRAWN

Trakya University

Edirne, 22030, Turkey (Türkiye)

WITHDRAWN

Istanbul Universitesi Onkoloji Enstitusu

Istanbul, 34093, Turkey (Türkiye)

WITHDRAWN

Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

WITHDRAWN

Medipol Mega Universite Hastanesi

Istanbul, 34214, Turkey (Türkiye)

WITHDRAWN

Istanbul Medeniyet University Medical Faculty

Istanbul, 34722, Turkey (Türkiye)

WITHDRAWN

Ege Universitesi Tip Fakultesi Hastanesi - Tulay Aktas Onkoloji Hastanesi

Izmir, 35040, Turkey (Türkiye)

WITHDRAWN

Medical Park - Izmir Hastanesi

Izmir, 35575, Turkey (Türkiye)

WITHDRAWN

Inonu Universitesi - Turgut Ozal Tip Merkezi

Malatya, 44280, Turkey (Türkiye)

WITHDRAWN

Baskent University

Yüreğir, 01250, Turkey (Türkiye)

WITHDRAWN

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

RECRUITING

Belfast Health and Social Care Trust, Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

RECRUITING

University Hospitals Birmingham, Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

RECRUITING

Addenbrooke's Hospital - Cambridge University Hospitals

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

Velindre Cancer Centre

Cardiff, CF14 2TL, United Kingdom

RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

RECRUITING

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

Leeds, LS9 7TF, United Kingdom

RECRUITING

The Clatterbridge Cancer Centre

Liverpool, L7 8YA, United Kingdom

RECRUITING

University College London Hospitals

London, NW 12 PG, United Kingdom

RECRUITING

Guy's Cancer Centre, Guy's Hospital

London, SE1 9RT, United Kingdom

RECRUITING

The Royal Marsden Hospital NHS Foundation Trust - Fulham Road

London, SW3 6JJ, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

RECRUITING

Oxford Cancer Centre

Oxford, OX3 7LE, United Kingdom

RECRUITING

Royal Preston Hospital Lancashire Teaching Hospitals NHS Foundation Trust

Preston, PR2 9HT, United Kingdom

RECRUITING

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

RECRUITING

Mount Vernon Cancer Centre, East and North Hertfordshire NHS Trust

Stevenage, SG1 4AB, United Kingdom

RECRUITING

The Royal Marsden Hospital - Sutton

Sutton, SM2 5PT, United Kingdom

RECRUITING

Torbay Hospital - South Devon Healthcare NHS Foundation Trust

Torquay, TQ2 7AA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Neoplasm Metastasis; Recurrence

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• BioNTech Responsible Person

  BioNTech SE

  STUDY DIRECTOR

Central Study Contacts

BioNTech clinical trials patient information

CONTACT

+49 6131 9084; patients@biontech.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 1, 2020
• Study Start: January 7, 2021
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (4); TW (7); TU (12); PL (7); CZ (2); CA (5); IL (4); KR (8); AR (9); IT (8); BR (14); BE (3); GB (19); DE (17); AU (8); FR (11); ME (9); PT (6); SE (3); ES (12); CL (3); US (18)