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Clinical Trials in the UK / NCT06806852
Active, not recruiting Phase 1

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

NCT06806852 · tracked via the Priya Life Science UK tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 1
Started
2025-05-14
Last updated
2026-09-15

Condition(s) studied

Head and Neck Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

BI 770371PembrolizumabCetuximab

BI 770371: BI 770371

Pembrolizumab: Pembrolizumab

Cetuximab: Cetuximab

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (51)

FacilityCityRegionStatus
Norton Cancer Institute, Downtown Louisville Kentucky
M Health Fairview Clinics and Surgery Center - Minneapolis Minneapolis Minnesota
The Ohio State University Wexner Medical Center Columbus Ohio
Gosford Hospital Gosford New South Wales
Andrew Love Cancer Centre Geelong Victoria
Hospital de Amor Barretos Brazil
Liga Norte Riograndense contra o cancer Natal Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto Brazil
MBAL Sveta Sofia Sofia Bulgaria
CTR Oscar Lambret Lille France
CTR Leon Berard Lyon France
HOP Timone Marseille France
Institut Gustave Roussy Villejuif France
ARENSIA Exploratory Medicine LLC Tbilisi Georgia
Städtisches Klinikum Braunschweig gGmbH Braunschweig Germany
Universitätsklinikum Jena Jena Germany
Universität Leipzig Leipzig Germany
Universitätsklinikum Ulm Ulm Germany
Semmelweis University Budapest Hungary
Clinexpert Gyongyos Gyöngyös Hungary
Istituto Scientifico Romagnolo Meldola (FC) Italy
Azienda Ospedaliera Universitaria Integrata Verona Verona Italy
Hokkaido University Hospital Hokkaido, Sapporo Japan
Kobe University Hospital Hyogo, Kobe Japan
Kansai Medical University Hospital Osaka, Hirakata Japan
Shizuoka Cancer Center Shizuoka, Sunto-gun Japan
Japanese Foundation for Cancer Research Tokyo, Koto-ku Japan
Unidad Clinica Farmacologica Bioemagno Mexico City Mexico
Centro Oncologico Personalizado México Mexico
Instituto Nacional de Cancerologia México Mexico
Centro Oncológico Internacional Tlajomulco de Zuñiga Mexico
ARENSIA Exploratory Medicine Chisinau Moldova
Center of Oncology of the Lublin Region St. Jana z Dukli Lublin Poland
"Prof. Dr. Alexandru Trestioreanu" Oncology Institut Bucharest Romania
National University Hospital-Singapore-22806 Singapore Singapore
Severance Hospital Seoul South Korea
Samsung Medical Center Seoul South Korea
The Catholic University of Korea, St.Vincent's Hospital Suwon South Korea
Hospital Universitari Vall d'Hebron Barcelona Spain
Cantonspital Aarau Aarau Switzerland

+ 11 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06806852 on ClinicalTrials.gov ↗ ← All trials in the UK