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

Running, not enrolling · Phase 1

Conditions studied: Head and Neck Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID: NCT06806852
Run by: Boehringer Ingelheim
People needed: 91
Starts: 2025-05-14
Expected to finish: 2027-08-31
Last updated by the study team: 2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.).
Further inclusion criteria apply.

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.
Further exclusion criteria apply.

Where it is running

M Health Fairview Clinics and Surgery Center - Minneapolis — Minneapolis, Minnesota, United States
The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
Gosford Hospital — Gosford, New South Wales, Australia
Andrew Love Cancer Centre — Geelong, Victoria, Australia
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
Norton Cancer Institute, Downtown — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.