A study to investigate whether treatment with BI 770371 in combination with Pembrolizumab with or without Cetuximab helps people with head and neck cancer compared to Pembrolizumab alone
Zusammenfassung der Studie
The aim of this study is to find out whether the investigational drugs BI 770371 and Pembrolizumab, with or without Cetuximab, help people with HNSCC. HNSCC is a relatively common disease. According to the latest GLOBOCAN estimates (2020), HNSCC is the seventh most common cancer worldwide. It accounts for an estimated 890,000 new cases (about 4.5% of all cancer diagnoses worldwide) and 450,000 deaths per year (about 4.6% of global cancer deaths). The incidence of HNSCC continues to rise and is expected to increase by 30% (i.e., 1.08 million new cases annually) by 2030. If you develop HNSCC (squamous cell carcinoma of the head and neck), you may suffer from various symptoms. This type of cancer occurs in the mouth, nose, throat, and sinuses. The goal of this study is to find out whether the combination of different investigational substances can shrink tumors in people with advanced head and neck cancer. If HNSCC is diagnosed early, it can be treated with surgery or radiation. Unfortunately, HNSCC is often diagnosed late. Most people with advanced HNSCC receive multiple treatments, including surgery, radiation, and chemotherapy. After treatment, the tumor often grows back. Further treatments are necessary to prevent tumor recurrence. The medications tested in this study are antibodies that work against cancer in different ways. BI 770371 and Pembrolizumab may help the immune system fight cancer. Cetuximab blocks growth signals and may inhibit tumor growth. Therefore, we are investigating in this study whether the investigational drug BI 770371 is effective and safe for HNSCC. Participation in this study lasts as long as you benefit from the treatment, not longer than 2 years. As part of your participation, you will come to us for approximately 10 treatment cycles. Each cycle may include 1-4 appointments.
(BASEC)
Untersuchte Intervention
Metastatic or recurrent squamous cell carcinoma of the head and neck (HNSCC)
(BASEC)
Untersuchte Krankheit(en)
metastatic or recurrent squamous cell carcinoma of the head and neck (HNSCC)
(BASEC)
Cancer type: People with a specific type of head and neck cancer (known as squamous cell carcinoma of the head and neck) that has either spread (metastatic) or recurred (recurrent). The cancer must be located in the oral cavity, oropharynx (throat), hypopharynx, or larynx (voice box). Additionally, a cure through surgery or radiation must not be possible. PD-L1 positive tumors: The tumor must test positive for a protein called PD-L1 (with a result of 1 or higher on a specific lab test). This test result must be available before enrollment in the study and can come from a biopsy performed within the last 12 months. p16 tests (only for oropharyngeal carcinoma): If the cancer started in the oropharynx (throat), a test called p16 must be performed to check for the presence of a specific marker. Both positive and negative results are acceptable. This test is not required for cancers of the oral cavity, hypopharynx, or larynx (voice box). (BASEC)
Ausschlusskriterien
Other cancer types: Individuals with cancer in the nasopharynx (nasopharyngeal area), nasal cavity, or sinuses, or with cancer of unknown origin are not eligible. Urgent medical need: If the cancer causes serious problems that require immediate treatment (such as pressure on the spinal cord, severe pain, or bone fractures), the individual cannot participate. Recently failed treatment: If the cancer recurred or worsened within 6 months after completing treatment that was supposed to lead to a cure, the person is not eligible. (BASEC)
Studienstandort
Aarau, Zürich
(BASEC)
Sponsor
IQVIA AG Branch Basel
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. Csilla Ponner
+49 6132 77-0
csilla.ponner@clutterboehringer-ingelheim.comBoehringer Ingelheim International GmbH
(BASEC)
Wissenschaftliche Auskünfte
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Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
05.08.2025
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
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) (BASEC)
Wissenschaftlicher Titel
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Öffentlicher Titel
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Studientyp
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Studiendesign
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Ein-/Ausschlusskriterien
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Primäre und sekundäre Endpunkte
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Ergebnisse der Studie
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