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New vaccine plus immunotherapy shows promise against HPV-Linked head and neck cancer

NCT ID NCT04534205

Disease control Sponsor: BioNTech SE Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 6 times

Summary

This trial tests whether adding a vaccine called BNT113 to the immunotherapy drug pembrolizumab works better than pembrolizumab alone for people with advanced head and neck cancer linked to HPV16. About 350 participants will receive either the combination or the standard single drug. The goal is to see if the combo helps people live longer and keeps cancer from growing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BNT113 (a vaccine targeting HPV16) and pembrolizumab (an immunotherapy drug)
What this could lead to
If it works, this combination could improve survival and delay cancer progression for people with HPV16-positive head and neck cancer, offering a new first-line treatment option.
What could go wrong
This is an early-to-mid stage trial (Phase II/III) with only 350 participants. The vaccine may not add benefit over pembrolizumab alone, and side effects from the combination could be more severe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

358 people

The number who actually took part.

Started

Jan 2021

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma Neoplasm Metastasis Recurrence Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic head and neck cancer Recurrent head and neck cancer Unresectable head and neck squamous cell carcinoma

Contacts and locations

Locations

  • ASST Spedali Civili Brescia

    Brescia, 25123, Italy

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN, United Kingdom

  • Addenbrooke's Hospital - Cambridge University Hospitals

    Cambridge, CB2 0QQ, United Kingdom

  • Ajou University Hospital

    Suwon, 16499, South Korea

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • Belfast Health and Social Care Trust, Belfast City Hospital

    Belfast, BT9 7AB, United Kingdom

  • British Columbia Cancer Agency

    Kelowna, V1Y 5L3, Canada

  • CAIPO Centro para la Atencion Integral del Paciente Oncologico

    San Miguel de Tucumán, 4000, Argentina

  • CHR de la Citadelle

    Liège, 4000, Belgium

  • CHU de BORDEAUX, Hopital Saint Andre

    Bordeaux, 33075, France

  • CHU de Caen Normandie

    Caen, 14033, France

  • CHU de Tours Hopital Bretonneau

    Tours, 37044, France

  • Cancer Research SA

    Adelaide, 5000, Australia

  • Caritas Klinikum Saarbrucken St. Theresia

    Saarbrücken, 66113, Germany

  • Central Hospital of Northern Pest - Military Hospital

    Budapest, 1062, Hungary

  • Centre Georges Francois Leclerc

    Dijon, 21079, France

  • Centro Estatal de Cancerologia de Chihuahua

    Chihuahua City, 31000, Mexico

  • Centro Hospitalar Universitario Lisboa Norte

    Lisbon, 1649-028, Portugal

  • Centro Oncologico Riojano Integral

    La Rioja, 5300, Argentina

  • Centro de Atencion e Investigacion Clinica en Oncologia (CAICO)

    Yucatán, 97134, Mexico

  • Centro de Estudios Clinicos SAGA

    Santiago, 7500653, Chile

  • Centro de Estudios y Prevención del Cáncer (CEPREC)

    Tuxtla Gutiérrez, Region Chiapas, 29038, Mexico

  • Centro de Investigacion Pergamino SA - Clinica Pergamino

    Pergamino, 2700, Argentina

  • Centro de Oncología e Investigación Buenos Aires COIBA

    Berazategui, B1884BBF, Argentina

  • Chang Bing Show Chwan Memorial Hospital

    Changhua, 50544, Taiwan

  • Chang Gung Memorial Hospital-Kaohsiung Branch

    Kaohsiung City, 833401, Taiwan

  • Changhua Christian Hospital

    Changhua, 50006, Taiwan

  • Charite Universitätsklinikum Berlin - Campus Benjamin Franklin

    Berlin, 13353, Germany

  • Chonnam National University Hwasun Hospital

    Hwasun, 58128, South Korea

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

    Madrid, 28027, Spain

  • Complejo Hospitalario de Jaen

    Jaén, 23007, Spain

  • Consultorio del Dr. Joaquín Gabriel Reinoso Toledo

    Monterrey, 64320, Mexico

  • Cross Cancer Institute

    Edmonton, T6G 1Z2, Canada

  • Cryptex Investigacion SA de CV

    Mexico City, 06100, Mexico

  • Fakultni Nemocnice Olomouc

    Olomouc, 779 00, Czechia

  • Flinders Medical Centre

    Bedford Park, 5042, Australia

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

    Caxias do Sul, 95070-560, Brazil

  • Fundación Arturo López Pérez

    Santiago, 7500921, Chile

  • Fundação PIO XII - Hospital de Amor Barretos

    Barretos, 14784-400, Brazil

  • Guy's Cancer Centre, Guy's Hospital

    London, SE1 9RT, United Kingdom

  • HNO, Kopf-und Halschirurgie Ordensklinikum Linz Barmherzigen Schwestern

    Linz, 4010, Austria

  • Hadassah Medical Center - Sharett Institute of Oncology

    Jerusalem, 49100, Israel

  • Hopital de la Timone

    Marseille, 13005, France

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280, Mexico

  • Hospital Clinic Barcelona

    Barcelona, 08036, Spain

  • Hospital Erasto Gaertner

    Curitiba, 81520-060, Brazil

  • Hospital Gustave Roussy

    Villejuif, 94800, France

  • Hospital La Fe

    Valencia, 46026, Spain

  • Hospital Mae de Deus

    Porto Alegre, 90110-270, Brazil

  • Hospital Marcio Cunha

    Ipatinga, 35162-189, Brazil

  • Hospital Na Bulovce (Nemocnice na Bulovce)

    Prague 8 - Liben, 180 00, Czechia

  • Hospital Regional de Malaga

    Málaga, 29010, Spain

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000, Brazil

  • Hospital Sao Rafael

    Salvador, 41253-190, Brazil

  • Hospital Univ. Dr. Josep Trueta

    Girona, 17007, Spain

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

    Monterrey, 64460, Mexico

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222, Spain

  • Hospital Universitario Son Espases

    Palma de Mallorca, 07120, Spain

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, 15090-000, Brazil

  • IBCC - Instituto Brasileiro de Controle do Cancer

    Vila Mariana, 04014-002, Brazil

  • IPO Lisboa Francisco Gentil

    Lisbon, 1099-023, Portugal

  • IRCCS Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Institut Curie

    Paris, 75005, France

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

    Paris, 75014, France

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

    Rio de Janeiro, 20231-050, Brazil

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

    Coimbra, 3000-075, Portugal

  • Instituto de Oncologia de Cordoba

    Córdoba, X500AA1, Argentina

  • Instituto de Oncologia de Rosario

    Rosario, 2000, Argentina

  • Instituto do Cancer do Estado de São Paulo

    São Paulo, 01246-000, Brazil

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

    Porto Alegre, 90050-170, Brazil

  • Jewish General Hospital

    Montreal, H3T 1E2, Canada

  • John Flynn Private Hospital

    Tugun, 4224, Australia

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80708, Taiwan

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

    Cologne, 50937, Germany

  • Klinikum rechts der Isar der TUM

    München, 81675, Germany

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • LKH - Univ. Klinikum Graz

    Graz, 8036, Austria

  • Landeskrankenhaus/ Univ.-Kliniken Innsbruck

    Innsbruck, 6020, Austria

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

    Leeds, LS9 7TF, United Kingdom

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mater Salutis Hospital AULSS 9 della Regione Veneto

    Legnago, 37045, Italy

  • McGill University Health Centre

    Montreal, H4A 3J1, Canada

  • Medizinische Hochschule Hannover (MHH)

    Hanover, 30625, Germany

  • Medizinische Universitaetsklinik Tuebingen

    Tübingen, 72076, Germany

  • Memorial Sloan Kettering Cancer Center

    Long Island City, New York, 11101, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

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

    Stevenage, SG1 4AB, United Kingdom

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie

    Gliwice, 44-102, Poland

  • National Taiwan University Hospital

    Taipei, 100225, Taiwan

  • Norton Cancer Institute

    Louisville, Kentucky, 40241, United States

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB, United Kingdom

  • Nucleo de Oncologia da Bahia

    Salvador, 40170-070, Brazil

  • Oaxaca Site Management Organization S. C.

    Oaxaca City, 68000, Mexico

  • Oncocentro - Grupo Oncoclinicas

    Belo Horizonte, 30360-680, Brazil

  • Oncosite - Centro de Pesquisa Clinica em Oncologia

    Ijuí, 98700-000, Brazil

  • Oxford Cancer Centre

    Oxford, OX3 7LE, United Kingdom

  • Przychodnia Lekarska KOMED Roman Karaszewski

    Konin, 62-500, Poland

  • Rambam Health Clinical

    Haifa, 3109601, Israel

  • Royal North Shore Hospital

    Saint Leonards, 2065, Australia

  • Royal Preston Hospital Lancashire Teaching Hospitals NHS Foundation Trust

    Preston, PR2 9HT, United Kingdom

  • Sanatorio Britanico

    Rosario, 2000, Argentina

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Sociedad de Metabolismo y Corazón S.C.

    Veracruz, 91900, Mexico

  • Southern Medical Day Care Centre

    Wollongong, 2500, Australia

  • St Vincent's Hospital

    Fitzroy, VIC 3065, Australia

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

    Iserlohn, 58638, Germany

  • Stanford Cancer Institute

    Palo Alto, California, 94304, United States

  • Taichung Veterans General Hospital

    Taichung, 407219, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • The Catholic University of Korea St. Vincent's Hospital

    Suwon, 16247, South Korea

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

    Seoul, 06591, South Korea

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The Clatterbridge Cancer Centre

    Liverpool, L7 8YA, United Kingdom

  • The George Washington Cancer Center

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

  • The Royal Marsden Hospital - Sutton

    Sutton, SM2 5PT, United Kingdom

  • The Royal Marsden Hospital NHS Foundation Trust - Fulham Road

    London, SW3 6JJ, United Kingdom

  • The University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87131, United States

  • Torbay Hospital - South Devon Healthcare NHS Foundation Trust

    Torquay, TQ2 7AA, United Kingdom

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UCLA Cancer Care

    Los Angeles, California, 90095, United States

  • UNIVERSITAETSMEDIZIN der Johannes Gutenberg-Universitaet Mainz

    Mainz, 55131, Germany

  • Uniklinikum Salzburg, Univ. Klinik fur Innere Medizin III

    Salzburg, 5020, Austria

  • Univeritätsklinikum Münster

    Münster, 48149, Germany

  • Universitaetsklinik Heidelberg

    Heidelberg, 69124, Germany

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080, Germany

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

    Rostock, 18057, Germany

  • Universitair Ziekenhuis Brussel

    Brussels, 1090, Belgium

  • Universitair Ziekenhuis Gent UZ Gent

    Ghent, 9000, Belgium

  • University College London Hospitals

    London, NW 12 PG, United Kingdom

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD, United Kingdom

  • University Hospitals Birmingham, Queen Elizabeth Hospital

    Birmingham, B15 2TH, United Kingdom

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio, 45219, United States

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136, United States

  • Universitätsklinikum Leipzig

    Leipzig, 04103, Germany

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

    Ulm, 89081, Germany

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214, Poland

  • Velindre Cancer Centre

    Cardiff, CF14 2TL, United Kingdom

  • Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

    Wroclaw, 50-981, Poland

  • Yale University

    New Haven, Connecticut, 06511, United States

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