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A phase 1b/2, open-label study of amivantamab monotherapy and amivantamab in addition to standard of care therapeutic agents in participants with recurrent/metastatic head and neck squamous cell carcinoma

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Trial Profile

A phase 1b/2, open-label study of amivantamab monotherapy and amivantamab in addition to standard of care therapeutic agents in participants with recurrent/metastatic head and neck squamous cell carcinoma

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 25 May 2025

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At a glance

  • Drugs Amivantamab (Primary) ; Paclitaxel (Primary) ; Pembrolizumab (Primary)
  • Indications Carcinoma; Head and neck cancer; Hypopharyngeal cancer; Laryngeal cancer; Mouth neoplasm; Oropharyngeal cancer; Squamous cell cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms OrigAMI-4
  • Sponsors Janssen Research & Development; Janssen-Cilag

Most Recent Events

  • 20 Feb 2025 Planned number of patients changed from 217 to 247.
  • 20 Feb 2025 Planned End Date changed from 14 May 2027 to 17 Apr 2028.
  • 10 Jan 2025 Planned End Date changed from 15 Apr 2027 to 14 May 2027.

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