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
A Phase Ib Open Label Randomised Clinical Trial to Evaluate Safety and Efficacy of BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Compared With Pembrolizumab Monotherapy for the First-line Treatment of Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)
2 other identifiers
interventional
90
22 countries
52
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2025
Typical duration for phase_1
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2025
CompletedFirst Posted
Study publicly available on registry
February 4, 2025
CompletedStudy Start
First participant enrolled
May 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
April 28, 2026
April 1, 2026
2.3 years
January 28, 2025
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response (OR) with confirmation
OR defined as the best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to response evaluation criteria in solid tumours version 1.1 (RECIST v1.1). Objective response (OR) will be defined by investigator's assessment from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent.
Up to 27 months
Secondary Outcomes (7)
Occurrence of treatment related adverse event (AE) from first treatment administration until the earliest of 90 days after the last dose, death, subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent
Up to 27 months
Occurrence of treatment related AE leading to treatment discontinuation from first treatment administration until the earliest of 90 days after the last dose, death, subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent
Up to 27 months
Overall survival (OS)
Up to 27 months
Overall survival at 6 and 12 months (OS6 and OS12)
At 6 months and 12 months
Progression-free survival (PFS)
Up to 27 months
- +2 more secondary outcomes
Study Arms (3)
Pembrolizumab
EXPERIMENTALPembrolizumab + BI 770371
EXPERIMENTALPembrolizumab + BI 770371 + Cetuximab
EXPERIMENTALInterventions
Pembrolizumab
Eligibility Criteria
You may qualify if:
- 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.).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
Norton Cancer Institute, Downtown
Louisville, Kentucky, 40202, United States
M Health Fairview Clinics and Surgery Center - Minneapolis
Minneapolis, Minnesota, 55455, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Gosford Hospital
Gosford, New South Wales, 2250, Australia
Andrew Love Cancer Centre
Geelong, Victoria, 3220, Australia
Hospital de Amor
Barretos, 14784-400, Brazil
Liga Norte Riograndense contra o cancer
Natal, 59062-000, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, 15090-000, Brazil
MBAL Sveta Sofia
Sofia, 1404, Bulgaria
CTR Oscar Lambret
Lille, 59020, France
CTR Leon Berard
Lyon, 69373, France
HOP Timone
Marseille, 13385, France
Institut Gustave Roussy
Villejuif, 94805, France
ARENSIA Exploratory Medicine LLC
Tbilisi, 0112, Georgia
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, 38114, Germany
Universitätsklinikum Jena
Jena, 07743, Germany
Universität Leipzig
Leipzig, 04103, Germany
Universitätsklinikum Ulm
Ulm, 89081, Germany
Semmelweis University
Budapest, 1083, Hungary
Clinexpert Gyongyos
Gyöngyös, 3200, Hungary
Istituto Scientifico Romagnolo
Meldola (FC), 47014, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126, Italy
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648, Japan
Kobe University Hospital
Hyogo, Kobe, 650-0017, Japan
Kansai Medical University Hospital
Osaka, Hirakata, 573-1191, Japan
Shizuoka Cancer Center
Shizuoka, Sunto-gun, 411-8777, Japan
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550, Japan
Unidad Clinica Farmacologica Bioemagno
Mexico City, 04660, Mexico
Instituto Nacional de Cancerologia
México, 14080, Mexico
Centro Oncológico Internacional
Tlajomulco de Zuñiga, 45640, Mexico
ARENSIA Exploratory Medicine
Chisinau, MD-2025, Moldova
Center of Oncology of the Lublin Region St. Jana z Dukli
Lublin, 20090, Poland
"Prof. Dr. Alexandru Trestioreanu" Oncology Institut
Bucharest, 022328, Romania
National University Hospital-Singapore-22806
Singapore, 119228, Singapore
Severance Hospital
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
The Catholic University of Korea, St.Vincent's Hospital
Suwon, 16247, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Cantonspital Aarau
Aarau, 5001, Switzerland
National Taiwan University Hospital
Taipei, 10048, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Siriraj Hospital
Bangkoknoi, 10700, Thailand
Adana City Hospital
Adana, 01220, Turkey (Türkiye)
Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 06200, Turkey (Türkiye)
Hacettepe University Oncology Hospital
Ankara, 06230, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, 06800, Turkey (Türkiye)
Istanbul University Medical Faculty Capa Hospital
Istanbul, 34093, Turkey (Türkiye)
St Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
The Royal Marsden Hospital, London
London, SW3 6JJ, United Kingdom
The Royal Marsden Hospital, Sutton
Sutton, SM2 5PT, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2025
First Posted
February 4, 2025
Study Start
May 14, 2025
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
- Access Criteria
- For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.