A Study to Test Whether Treatment With BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Helps People With Head and Neck Cancer Compared With Pembrolizumab Alone

Last updated: July 15, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Recruiting

Phase

1

Condition

Head And Neck Cancer

Carcinoma

Squamous Cell Carcinoma

Treatment

Pembrolizumab

Cetuximab

BI 770371

Clinical Study ID

NCT06806852
1501-0002
2024-517091-38-00
  • Ages > 18
  • All Genders

Study Summary

This study is open to adults with head and neck cancer. The purpose of this study is to find out whether combining different study medicines makes tumors shrink in people with head and neck cancer.

The tested medicines in this study are antibodies that act in different ways against cancer. BI 770371 and pembrolizumab may help the immune system fight cancer. Cetuximab blocks growth signals and may prevent the tumor from growing.

Participants are put into 3 groups randomly. Each group receives a different combination of study medicines. All study medicines are given as an infusion into a vein at the study site.

Participants can stay in the study as long as they benefit from treatment. Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with histologically confirmed metastatic or recurrent HNSCC of the primarytumour location of oral cavity, oropharynx, hypopharynx, and larynx not amenable tolocoregional treatment with curative intent.

  • Willingness to provide pretreatment (baseline) biopsy / tissue to the sponsor (freshor archival one). A recent biopsy (<3 months) is preferred, however an archivalbiopsy up to 12 months prior to screening could be accepted. If these requirementscannot be met, then the patient may be allowed to enter the study at Sponsordiscretion, after agreement between the Investigator and Sponsor. Details on therequirements for archival tumour tissue and on biopsy sample collection are providedin the Laboratory Manual.

  • Patients who have not received prior systemic treatment for metastatic or recurrentHNSCC. Systemic therapy (including cetuximab) which was completed more than 6 monthsprior to progression of disease if given as part of multimodal treatment for locallyadvanced disease is allowed.

  • Patients who do not have contraindications to pembrolizumab monotherapy according topembrolizumab local label, guidelines, treatment standards, regulations or thedocument (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 tocetuximab local label, guidelines, treatment standards, regulations, or the document (label of another country if cetuximab local label is not available) provided in theISF 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

Exclusion Criteria:

  • Nasopharyngeal carcinoma (NPC) of any histology, primary tumour location at nasalcavity, 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 therapyfor locoregionally advanced disease with curative intent.

  • Receiving treatment for brain metastases or Leptomeningeal Disease (LMD) which mayinterfere with safety and/or endpoint assessment. Patients with previously diagnosedbrain metastases are eligible if they have completed their treatment and haverecovered from the acute effects of radiation therapy or surgery prior to trialentry, have discontinued corticosteroid treatment for these metastases and areclinically stable, off anticonvulsants for at least 4 weeks and are neurologicallystable 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 isconsidered the preferred therapy by the investigator or treating physician).

  • Prior treatment with any anti signal Regulatory Protein Alpha (SIRPα) oranti-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 agentdirected 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.

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: Pembrolizumab
Phase: 1
Study Start date:
May 14, 2025
Estimated Completion Date:
March 30, 2028

Connect with a study center

  • Gosford Hospital

    Gosford, New South Wales 2250
    Australia

    Site Not Available

  • Andrew Love Cancer Centre

    Geelong, Victoria 3220
    Australia

    Site Not Available

  • Hospital de Amor

    Barretos, 14784-400
    Brazil

    Site Not Available

  • Liga Norte Riograndense contra o cancer

    Natal, 59062-000
    Brazil

    Active - Recruiting

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

    São José do Rio Preto, 15090-000
    Brazil

    Active - Recruiting

  • MBAL Sveta Sofia

    Sofia, 1404
    Bulgaria

    Site Not Available

  • CTR Oscar Lambret

    Lille, 59020
    France

    Site Not Available

  • CTR Leon Berard

    Lyon Cedex 08, 69373
    France

    Site Not Available

  • HOP Timone

    Marseille, 13385
    France

    Site Not Available

  • INS Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • ARENSIA Exploratory Medicine LLC

    Tbilisi, 0112
    Georgia

    Site Not Available

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38114
    Germany

    Site Not Available

  • Universitätsklinikum Jena

    Jena, 07743
    Germany

    Site Not Available

  • Universität Leipzig

    Leipzig, 04103
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm, 89081
    Germany

    Site Not Available

  • National Institute of Oncology

    Budapest, 1122
    Hungary

    Site Not Available

  • Semmelweis University

    Budapest, 1083
    Hungary

    Site Not Available

  • Clinexpert Gyongyos

    Gyongyos, 3200
    Hungary

    Site Not Available

  • Istituto Scientifico Romagnolo

    Meldola (fc), 47014
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milano, 20133
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria "Federico II"

    Napoli, 80131
    Italy

    Site Not Available

  • Istittuo Nazionale Tumori Regina Elena - IRCCS

    Roma, 00144
    Italy

    Site Not Available

  • A.O. Univ. Integrata di Verona

    Verona, 37126
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126
    Italy

    Site Not Available

  • Hokkaido University Hospital

    Hokkaido, Sapporo, 060-8648
    Japan

    Site Not Available

  • Kobe University Hospital

    Hyogo, Kobe, 650-0017
    Japan

    Site Not Available

  • Kansai Medical University Hospital

    Osaka, Hirakata, 573-1191
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Shizuoka, Sunto-gun, 411-8777
    Japan

    Site Not Available

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550
    Japan

    Site Not Available

  • Samsung Medical Center

    Seoul, 135-710
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

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

    Suwon-si, 16247
    Korea, Republic of

    Site Not Available

  • Unidad Clinica Farmacologica Bioemagno

    Ciudad de México, 04660
    Mexico

    Site Not Available

  • Centro Oncologico Personalizado

    Mexico, 06760
    Mexico

    Site Not Available

  • Instituto Nacional de Cancerologia

    Mexico, 14080
    Mexico

    Site Not Available

  • Centro Oncológico Internacional

    Tlajomulco de Zuñiga, 45640
    Mexico

    Site Not Available

  • ARENSIA Exploratory Medicine

    Chisinau, MD-2025
    Moldova, Republic of

    Site Not Available

  • National Oncology Institute Maria Sklodowskiej Curie State Research Institute

    Gliwice, 44102
    Poland

    Site Not Available

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

    Lublin, 20090
    Poland

    Site Not Available

  • "Prof. Dr. Alexandru Trestioreanu" Oncology Institut

    Bucharest, 022328
    Romania

    Site Not Available

  • National University Hospital-Singapore-22806

    Singapore, 119228
    Singapore

    Site Not Available

  • Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Virgen de la Victoria

    Malaga, 29010
    Spain

    Site Not Available

  • Hospital Clínico de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Cantonspital Aarau

    Aarau, 5001
    Switzerland

    Site Not Available

  • University Hospital Zurich

    Zuerich, 8091
    Switzerland

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10048
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • Siriraj Hospital

    Bangkoknoi, 10700
    Thailand

    Site Not Available

  • Adana City Hospital

    Adana, 01220
    Turkey

    Site Not Available

  • Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 06200
    Turkey

    Site Not Available

  • Ankara Bilkent City Hospital

    Ankara, 06800
    Turkey

    Site Not Available

  • Hacettepe University Oncology Hospital

    Ankara, 06230
    Turkey

    Active - Recruiting

  • Istanbul University Medical Faculty Capa Hospital

    Istanbul, 34093
    Turkey

    Site Not Available

  • Ege University Tulay Aktas Oncology Hospital

    Izmir, 35100
    Turkey

    Site Not Available

  • St Bartholomew's Hospital

    London, EC1A 7BE
    United Kingdom

    Site Not Available

  • The Royal Marsden Hospital, Chelsea

    London, SW3 6JJ
    United Kingdom

    Site Not Available

  • The Royal Marsden Hospital, Sutton

    Sutton, SM2 5PT
    United Kingdom

    Site Not Available

  • University of Illinois Hospital and Health Sciences System

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Norton Cancer Institute, Downtown

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Norton Healthcare - Norton Cancer Institute - Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Texas Oncology - San Antonio

    San Antonio, Texas 98240
    United States

    Site Not Available

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