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New cocktail of cancer drugs shows promise in early trial

NCT ID NCT06806852

Disease control Sponsor: Boehringer Ingelheim 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 16, 2026 · Updated 13 times

Summary

This study tests whether combining three different antibodies—BI 770371, pembrolizumab, and cetuximab—can shrink tumors in people with head and neck cancer that has spread or come back. About 91 adults are randomly assigned to one of three treatment groups. The goal is to see if the combinations are safe and effective compared to pembrolizumab alone.

What this could mean

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

Active substance
BI 770371, pembrolizumab, and cetuximab (antibodies given as infusions)
What this could lead to
If successful, this could lead to a more effective first-line treatment for metastatic or recurrent head and neck cancer, potentially shrinking tumors and improving outcomes.
What could go wrong
This is an early phase 1 trial with only 91 participants, so results may not apply to everyone. The combination of drugs may cause side effects or not work better than standard therapy.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

91 people

The number who actually took part.

Started

May 2025

Expected to finish

Aug 2027

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.

Inclusion Criteria: * Patients with histologically confirmed metastatic or recurrent HNSCC of the primary tumour location of oral cavity, oropharynx, hypopharynx, and larynx not amenable to locoregional treatment with curative intent. * Willingness to provide pretreatment (baseline) biopsy/tissue to the sponsor (fresh or archival one). A newly obtained biopsy is preferred but an archival sample is acceptable, with tumor tissue (formalin fixed paraffin embedded \[FFPE\] block preferred, or at least 10 freshly sectioned unstained FFPE slides) from a core or excisional biopsy. Any deviation from this rule requires approval by the sponsor. Details on the requirements for archival tumour tissue and on biopsy sample collection are provided in the Laboratory Manual. * Patients who have not received prior systemic treatment for metastatic or recurrent HNSCC. Systemic therapy (including cetuximab) which was completed more than 6 months prior to progression of disease if given as part of multimodal treatment for locally advanced disease is allowed. * Patients who do not have contraindications to pembrolizumab monotherapy according to pembrolizumab local label, guidelines, treatment standards, regulations or the document (label of another country if pembrolizumab local label is not available) provided in the investigator site file (ISF) by the sponsor. * Patients who do not have contraindications to treatment with cetuximab according to cetuximab local label, guidelines, treatment standards, regulations, or the document (label of another country if cetuximab local label is not available) provided in the ISF by the sponsor. * Presence of at least one measurable non-central nervous system (CNS) lesion (according to RECIST v1.1.). * Further inclusion criteria apply. Exclusion Criteria: * Nasopharyngeal carcinoma (NPC) of any histology, primary tumour location at nasal cavity, paranasal sinuses of any histology, any cancer of unknown primary. * Any tumour location necessitating an urgent therapeutic intervention (e.g., palliative care, surgery, or radiation therapy), such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture. * Patients with progressive HNSCC within 6 months of completion of systemic therapy for locoregionally advanced disease with curative intent. * Receiving treatment for brain metastases or leptomeningeal disease (LMD) which may interfere with safety and/or endpoint assessment. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to trial entry, have discontinued corticosteroid treatment for these metastases and are clinically stable, off anticonvulsants for at least 4 weeks and are neurologically stable before enrollment. * Patients for whom single agent pembrolizumab is not the preferred treatment (e.g. patients for whom chemotherapy or anti-PD-1 in combination with chemotherapy is considered the preferred therapy by the investigator or treating physician). * Prior treatment with any anti signal regulatory protein alpha (SIRPα) or anti-integrin-associated protein (CD47) agent, regardless of treatment intent. * Prior cancer treatment with any anti PD-1 or anti PD-L1 agent or with an agent directed to another stimulatory or co-inhibitory Tcell receptor (e.g. CTLA-4, OX 40, CD137), regardless of treatment intent. * Prior allogeneic stem cell or solid organ transplantation. * Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma metastatic squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

Head and neck squamous cell carcinoma

Contacts and locations

Locations

  • "Prof. Dr. Alexandru Trestioreanu" Oncology Institut

    Bucharest, 022328, Romania

  • ARENSIA Exploratory Medicine

    Chisinau, MD-2025, Moldova

  • ARENSIA Exploratory Medicine LLC

    Tbilisi, 0112, Georgia

  • Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 06200, Turkey (Türkiye)

  • Adana City Hospital

    Adana, 01220, Turkey (Türkiye)

  • Andrew Love Cancer Centre

    Geelong, Victoria, 3220, Australia

  • Ankara Bilkent City Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126, Italy

  • CTR Leon Berard

    Lyon, 69373, France

  • CTR Oscar Lambret

    Lille, 59020, France

  • Cantonspital Aarau

    Aarau, 5001, Switzerland

  • Center of Oncology of the Lublin Region St. Jana z Dukli

    Lublin, 20090, Poland

  • Centro Oncologico Personalizado

    México, 06760, Mexico

  • Centro Oncológico Internacional

    Tlajomulco de Zuñiga, 45640, Mexico

  • Clinexpert Gyongyos

    Gyöngyös, 3200, Hungary

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, 15090-000, Brazil

  • Gosford Hospital

    Gosford, New South Wales, 2250, Australia

  • HOP Timone

    Marseille, 13385, France

  • Hacettepe University Oncology Hospital

    Ankara, 06230, Turkey (Türkiye)

  • Hokkaido University Hospital

    Hokkaido, Sapporo, 060-8648, Japan

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital de Amor

    Barretos, 14784-400, Brazil

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Instituto Nacional de Cancerologia

    México, 14080, Mexico

  • Istanbul University Medical Faculty Capa Hospital

    Istanbul, 34093, Turkey (Türkiye)

  • Istituto Scientifico Romagnolo

    Meldola (FC), 47014, Italy

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550, Japan

  • Kansai Medical University Hospital

    Osaka, Hirakata, 573-1191, Japan

  • Kobe University Hospital

    Hyogo, Kobe, 650-0017, Japan

  • Liga Norte Riograndense contra o cancer

    Natal, 59062-000, Brazil

  • M Health Fairview Clinics and Surgery Center - Minneapolis

    Minneapolis, Minnesota, 55455, United States

  • MBAL Sveta Sofia

    Sofia, 1404, Bulgaria

  • National Taiwan University Hospital

    Taipei, 10048, Taiwan

  • National University Hospital-Singapore-22806

    Singapore, 119228, Singapore

  • Norton Cancer Institute, Downtown

    Louisville, Kentucky, 40202, United States

  • Samsung Medical Center

    Seoul, 135-710, South Korea

  • Semmelweis University

    Budapest, 1083, Hungary

  • Severance Hospital

    Seoul, 03722, South Korea

  • Shizuoka Cancer Center

    Shizuoka, Sunto-gun, 411-8777, Japan

  • Siriraj Hospital

    Bangkoknoi, 10700, Thailand

  • St Bartholomew's Hospital

    London, EC1A 7BE, United Kingdom

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38114, Germany

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

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

    Suwon, 16247, South Korea

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • The Royal Marsden Hospital, Chelsea

    London, SW3 6JJ, United Kingdom

  • The Royal Marsden Hospital, Sutton

    Sutton, SM2 5PT, United Kingdom

  • Unidad Clinica Farmacologica Bioemagno

    Mexico City, 04660, Mexico

  • Universität Leipzig

    Leipzig, 04103, Germany

  • Universitätsklinikum Jena

    Jena, 07743, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

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