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A Phase 2/3, Randomized, Double-Blind, Controlled Study of Zanzalintinib (XL092) in Combination With Pembrolizumab vs Pembrolizumab in First-Line Treatment of Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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Trial Profile

A Phase 2/3, Randomized, Double-Blind, Controlled Study of Zanzalintinib (XL092) in Combination With Pembrolizumab vs Pembrolizumab in First-Line Treatment of Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 21 May 2025

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At a glance

  • Drugs Zanzalintinib (Primary) ; Pembrolizumab
  • Indications Carcinoma; Head and neck cancer; Hypopharyngeal cancer; Laryngeal cancer; Mouth neoplasm; Oropharyngeal cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms STELLAR-305
  • Sponsors Exelixis

Most Recent Events

  • 13 May 2025 According to an Exelixis Media Release, in second half 2025 the company anticipates data to drive a decision to move into the phase 3 portion of the STELLAR-305 trial in head and neck cancer.
  • 11 Feb 2025 According to an Exelixis Media Release, Exelixis and Merck formed a collaboration ,Under the terms of the collaboration, Merck will supply KEYTRUDA for this study.
  • 27 Dec 2024 Planned number of patients changed from 500 to 600.

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