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Unresectable Head and Neck Squamous Cell CarcinomaPhase 2/3AHEAD-MERITNCT04534205

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

A Phase 2/3 study testing BNT113 and Pembrolizumab in people with Unresectable Head and Neck Squamous Cell Carcinoma and Metastatic Head and Neck Cancer, run by BioNTech SE at 138 sites in 21 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BNT113 and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
358 participants
Where
138 sitesin 21 countries
Study dates
7 Jan 2021to Apr 2029
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

138 sites in 21 countries.

138 sites in 21 countries

United Kingdom19 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • Belfast Health and Social Care Trust, Belfast City Hospital

    Belfast, BT9 7AB

  • University Hospitals Birmingham, Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Addenbrooke's Hospital - Cambridge University Hospitals

    Cambridge, CB2 0QQ

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

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

    Leeds, LS9 7TF

  • The Clatterbridge Cancer Centre

    Liverpool, L7 8YA

  • University College London Hospitals

    London, NW 12 PG

  • Guy's Cancer Centre, Guy's Hospital

    London, SE1 9RT

  • The Royal Marsden Hospital NHS Foundation Trust - Fulham Road

    London, SW3 6JJ

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

  • Oxford Cancer Centre

    Oxford, OX3 7LE

  • Royal Preston Hospital Lancashire Teaching Hospitals NHS Foundation Trust

    Preston, PR2 9HT

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD

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

    Stevenage, SG1 4AB

  • The Royal Marsden Hospital - Sutton

    Sutton, SM2 5PT

  • Torbay Hospital - South Devon Healthcare NHS Foundation Trust

    Torquay, TQ2 7AA

Other trials in United Kingdom

United States15 sites

  • The University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87131

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio, 45219

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Memorial Sloan Kettering Cancer Center

    Long Island City, New York, 11101

  • UCLA Cancer Care

    Los Angeles, California, 90095

  • Norton Cancer Institute

    Louisville, Kentucky, 40241

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • Yale University

    New Haven, Connecticut, 06511

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Stanford Cancer Institute

    Palo Alto, California, 94304

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • The George Washington Cancer Center

    Washington D.C., District of Columbia, 20052

Other trials in United States

Brazil15 sites

  • Fundação PIO XII - Hospital de Amor Barretos

    Barretos, 14784-400

  • Oncocentro - Grupo Oncoclinicas

    Belo Horizonte, 30360-680

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

    Caxias do Sul, 95070-560

  • Hospital Erasto Gaertner

    Curitiba, 81520-060

  • Oncosite - Centro de Pesquisa Clinica em Oncologia

    Ijuí, 98700-000

  • Hospital Marcio Cunha

    Ipatinga, 35162-189

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

    Porto Alegre, 90050-170

  • Hospital Mae de Deus

    Porto Alegre, 90110-270

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000

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

    Rio de Janeiro, 20231-050

  • Nucleo de Oncologia da Bahia

    Salvador, 40170-070

  • Hospital Sao Rafael

    Salvador, 41253-190

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, 15090-000

  • Instituto do Cancer do Estado de São Paulo

    São Paulo, 01246-000

  • IBCC - Instituto Brasileiro de Controle do Cancer

    Vila Mariana, 04014-002

Other trials in Brazil

Germany14 sites

  • Charite Universitätsklinikum Berlin - Campus Benjamin Franklin

    Berlin, 13353

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

    Cologne, 50937

  • Medizinische Hochschule Hannover (MHH)

    Hanover, 30625

  • Universitaetsklinik Heidelberg

    Heidelberg, 69124

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

    Iserlohn, 58638

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • UNIVERSITAETSMEDIZIN der Johannes Gutenberg-Universitaet Mainz

    Mainz, 55131

  • Klinikum rechts der Isar der TUM

    München, 81675

  • Univeritätsklinikum Münster

    Münster, 48149

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

    Rostock, 18057

  • Caritas Klinikum Saarbrucken St. Theresia

    Saarbrücken, 66113

  • Medizinische Universitaetsklinik Tuebingen

    Tübingen, 72076

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

    Ulm, 89081

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080

Other trials in Germany

Mexico9 sites

  • Centro Estatal de Cancerologia de Chihuahua

    Chihuahua City, 31000

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280

  • Cryptex Investigacion SA de CV

    Mexico City, 06100

  • Consultorio del Dr. Joaquín Gabriel Reinoso Toledo

    Monterrey, 64320

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

    Monterrey, 64460

  • Oaxaca Site Management Organization S. C.

    Oaxaca City, 68000

  • Centro de Estudios y Prevención del Cáncer (CEPREC)

    Tuxtla Gutiérrez, Region Chiapas, 29038

  • Sociedad de Metabolismo y Corazón S.C.

    Veracruz, 91900

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

    Yucatán, 97134

Other trials in Mexico

France8 sites

  • CHU de BORDEAUX, Hopital Saint Andre

    Bordeaux, 33075

  • CHU de Caen Normandie

    Caen, 14033

  • Centre Georges Francois Leclerc

    Dijon, 21079

  • Hopital de la Timone

    Marseille, 13005

  • Institut Curie

    Paris, 75005

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

    Paris, 75014

  • CHU de Tours Hopital Bretonneau

    Tours, 37044

  • Hospital Gustave Roussy

    Villejuif, 94800

Other trials in France

Spain8 sites

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital Univ. Dr. Josep Trueta

    Girona, 17007

  • Complejo Hospitalario de Jaen

    Jaén, 23007

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222

  • Hospital Regional de Malaga

    Málaga, 29010

  • Hospital Universitario Son Espases

    Palma de Mallorca, 07120

  • Hospital La Fe

    Valencia, 46026

Other trials in Spain

Argentina7 sites

  • Centro de Oncología e Investigación Buenos Aires COIBA

    Berazategui, B1884BBF

  • Instituto de Oncologia de Cordoba

    Córdoba, X500AA1

  • Centro Oncologico Riojano Integral

    La Rioja, 5300

  • Centro de Investigacion Pergamino SA - Clinica Pergamino

    Pergamino, 2700

  • Instituto de Oncologia de Rosario

    Rosario, 2000

  • Sanatorio Britanico

    Rosario, 2000

  • CAIPO Centro para la Atencion Integral del Paciente Oncologico

    San Miguel de Tucumán, 4000

Other trials in Argentina

Australia6 sites

  • Cancer Research SA

    Adelaide, 5000

  • Flinders Medical Centre

    Bedford Park, 5042

  • St Vincent's Hospital

    Fitzroy, VIC 3065

  • Royal North Shore Hospital

    Saint Leonards, 2065

  • John Flynn Private Hospital

    Tugun, 4224

  • Southern Medical Day Care Centre

    Wollongong, 2500

Other trials in Australia

Austria4 sites

  • LKH - Univ. Klinikum Graz

    Graz, 8036

  • Landeskrankenhaus/ Univ.-Kliniken Innsbruck

    Innsbruck, 6020

  • HNO, Kopf-und Halschirurgie Ordensklinikum Linz Barmherzigen Schwestern

    Linz, 4010

  • Uniklinikum Salzburg, Univ. Klinik fur Innere Medizin III

    Salzburg, 5020

Other trials in Austria

Canada4 sites

  • Cross Cancer Institute

    Edmonton, T6G 1Z2

  • British Columbia Cancer Agency

    Kelowna, V1Y 5L3

  • Jewish General Hospital

    Montreal, H3T 1E2

  • McGill University Health Centre

    Montreal, H4A 3J1

Other trials in Canada

Italy4 sites

  • ASST Spedali Civili Brescia

    Brescia, 25123

  • Mater Salutis Hospital AULSS 9 della Regione Veneto

    Legnago, 37045

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • IRCCS Istituto Europeo di Oncologia

    Milan, 20141

Other trials in Italy

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie

    Gliwice, 44-102

  • Przychodnia Lekarska KOMED Roman Karaszewski

    Konin, 62-500

  • Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

    Wroclaw, 50-981

Other trials in Poland

South Korea4 sites

  • Korea University Anam Hospital

    Seoul, 02841

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

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

    Suwon, 16247

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

Belgium3 sites

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Universitair Ziekenhuis Gent UZ Gent

    Ghent, 9000

  • CHR de la Citadelle

    Liège, 4000

Other trials in Belgium

Israel3 sites

  • Rambam Health Clinical

    Haifa, 3109601

  • Hadassah Medical Center - Sharett Institute of Oncology

    Jerusalem, 49100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Portugal3 sites

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

    Coimbra, 3000-075

  • IPO Lisboa Francisco Gentil

    Lisbon, 1099-023

  • Centro Hospitalar Universitario Lisboa Norte

    Lisbon, 1649-028

Other trials in Portugal

Taiwan3 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80708

  • National Taiwan University Hospital

    Taipei, 100225

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Chile2 sites

  • Centro de Estudios Clinicos SAGA

    Santiago, 7500653

  • Fundación Arturo López Pérez

    Santiago, 7500921

Other trials in Chile

Czechia2 sites

  • Fakultni Nemocnice Olomouc

    Olomouc, 779 00

  • Hospital Na Bulovce (Nemocnice na Bulovce)

    Prague 8 - Liben, 180 00

Other trials in Czechia

Hungary1 site

  • Central Hospital of Northern Pest - Military Hospital

    Budapest, 1062

Other trials in Hungary

About this study

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

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.

Read more

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.

Being tested
BNT113, Pembrolizumab
Keywords
Cancer vaccine, RNA vaccine, HNSCC, BNT113, Pembrolizumab, HPV16, Metastatic, Unresectable, Recurrent, Head and neck, mRNA vaccine, HPV-positive, Head and neck cancer
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Neoplasm Metastasis, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04534205
Study groupRoleWhat they receive
Part A (Safety Run-In) - BNT113 + PembrolizumabExperimentalSafety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab.
Receives: Biological: BNT113; Biological: Pembrolizumab
Part B (Randomized phase) - BNT113 + PembrolizumabExperimentalBNT113 in combination with pembrolizumab.
Receives: Biological: BNT113; Biological: Pembrolizumab
Part B (Randomized phase) - Pembrolizumab monotherapyActive comparatorPembrolizumab monotherapy.
Receives: Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 27 months

  2. Part B - Overall survival (OS)

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

    Measured: up to 48 months

  3. 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.

    Measured: up to 48 months

Secondary outcomes (8)

  1. Part A and B - Overall response rate (ORR)

    ORR defined as the proportion of patients in whom a complete response (CR) or partial response (PR) (per RECIST 1.1 assessed by BICR and investigator) is observed as best overall response.

    Measured: up to 48 months

  2. Part A and B - Duration of response (DOR)

    DOR defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective tumor progression (progressive disease [PD] per RECIST 1.1) or death from any cause, whichever occurs first. In Part A, assessment will be done by both BICR and investigator; in Part B, only by BICR.

    Measured: up to 48 months

  3. Part A - Disease control rate (DCR)

    DCR defined as the proportion of patients in whom a CR or PR or stable disease (SD) (per RECIST 1.1, assessed at least 6 weeks after first dose by BICR and investigator) is observed as best overall response.

    Measured: up to 48 months

  4. Part B - Progression free survival (PFS)

    PFS defined as the time from randomization to the first objective tumor progression (per RECIST 1.1 by investigator's assessment) or death from any cause, whichever occurs first.

    Measured: up to 48 months

  5. Part B - PFS rate at 6 months

    Defined as the proportion of patients without objective tumor progression (per RECIST 1.1 assessed by BICR and investigator) or death from any cause

    Measured: from randomization until 6 months after randomization

  6. Part B - PFS rate at 12 months

    Defined as the proportion of patients without objective tumor progression (per RECIST 1.1 assessed by BICR and investigator) or death from any cause.

    Measured: from randomization until 12 months after randomization

  7. Part B - Occurrence of TEAEs - BNT113 in combination with pembrolizumab compared to pembrolizumab monotherapy

    TEAEs assessed according to CTCAE v5.0 including Grade ≥3, serious, and fatal TEAEs by relationship.

    Measured: up to 27 months

  8. Part B - Occurrence of dose reduction, delay, and discontinuation of trial treatments due to TEAEs

    BNT113 in combination with pembrolizumab compared to pembrolizumab monotherapy.

    Measured: up to 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2020
  2. Study start7 Jan 2021
  3. Primary completionApr 2029 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
358 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04534205
Sponsor's protocol ID
BNT113-01
Other IDs
2020-001400-41, 2024-512671-12-00
Acronym
AHEAD-MERIT
Status last verified
Oct 2026
First submitted
27 Aug 2020
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BNT113 and Pembrolizumab in people with Unresectable Head and Neck Squamous Cell Carcinoma and Metastatic Head and Neck Cancer, run by BioNTech SE at 138 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United Kingdom, United States, Brazil, Germany, Mexico and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A - Occurrence of treatment-emergent adverse event (TEAE) - BNT113 in combination with pembrolizumab (time frame: up to 27 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04534205.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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