Last updated 18 days ago
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
90 patients around the world
Available in Spain, Brazil, United States, Mexico
Boehringer Ingelheim
43Research sites
90Patients around the world
This study is for people with
Head and neck cancer
Squamous cell carcinoma of the head and neck
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 recent biopsy (<3 months) is preferred, however an archival biopsy up to 12 months prior to screening could be accepted. If these requirements cannot be met, then the patient may be allowed to enter the study at Sponsor discretion, after agreement between the Investigator and 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 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 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.
- 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 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. 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, regardless of treatment intent.Prior allogeneic stem cell or solid organ transplantation.Further exclusion criteria apply.
Sites
Hospital Británico de Buenos Aires - CABA
Recruiting
Sanatorio de la Mujer - Rosario
Recruiting
Sociedad de Beneficencia Hospital Italiano - Córdoba
Recruiting
Sociedad de Beneficencia Hospital Italiano - Córdoba
Recruiting
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Recruiting
Centro Oncológico Korben
Recruiting
Centro Privado de RMI Río Cuarto
Recruiting
Sanatorio Plaza
Recruiting
Instituto Médico Río Cuarto
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
SponsorBoehringer Ingelheim
Study typeInterventional
Conditions
Squamous cell carcinoma of the head and neck
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06806852
