Trial Profile

A 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)

Status: Recruiting

Phase of Trial: Phase I

Latest Information Update: 22 May 2025

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At a glance

Drugs BI 770371 (Primary) ; Cetuximab (Primary) ; Pembrolizumab (Primary)
Indications Head and neck cancer; Hypopharyngeal cancer; Laryngeal cancer; Mouth neoplasm; Oropharyngeal cancer; Squamous cell cancer
Focus Therapeutic Use
Sponsors Boehringer Ingelheim

22 May 2025 According to a Boehringer Ingelheim media release, company will present the latest data from this trial at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
14 May 2025 Status changed from not yet recruiting to recruiting.
15 Apr 2025 Planned primary completion date changed from 23 Jun 2027 to 31 Jul 2027.

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