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

Launched by BOEHRINGER INGELHEIM · Jan 28, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at new treatment options for adults with head and neck cancer, specifically a type called squamous cell carcinoma. The goal is to see if a combination of three different medications—BI 770371, pembrolizumab, and cetuximab—can help shrink tumors more effectively than pembrolizumab alone. These medications work by helping the immune system fight cancer and blocking signals that allow tumors to grow. Participants will be randomly assigned to one of three groups, each receiving a different combination of these treatments, which are given as infusions into a vein at the study site.

To be eligible for this trial, participants must have confirmed metastatic or recurrent head and neck cancer that cannot be treated with standard methods. They should not have received any previous systemic treatments for their cancer and must have at least one measurable tumor. Throughout the study, doctors will closely monitor participants’ health, check the size of their tumors, and watch for any side effects from the treatments. This study is not yet recruiting participants, but it aims to provide valuable information about potential new treatment options for head and neck cancer.

Gender

ALL

Eligibility criteria

• 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 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 (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.