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A Randomized, Double-blind, Placebo-controlled, 2-arm Phase III Study to Assess Efficacy and Safety of Xevinapant and Radiotherapy Compared to Placebo and Radiotherapy for Demonstrating Improvement of Disease-free Survival in Participants With Resected Squamous Cell Carcinoma of the Head and Neck, Who Are at High Risk for Relapse and Are Ineligible for High-dose Cisplatin (XRAY VISION)

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, 2-arm Phase III Study to Assess Efficacy and Safety of Xevinapant and Radiotherapy Compared to Placebo and Radiotherapy for Demonstrating Improvement of Disease-free Survival in Participants With Resected Squamous Cell Carcinoma of the Head and Neck, Who Are at High Risk for Relapse and Are Ineligible for High-dose Cisplatin (XRAY VISION)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 15 Jun 2025

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At a glance

  • Drugs Xevinapant (Primary)
  • Indications Head and neck cancer; Hypopharyngeal cancer; Laryngeal cancer; Mouth neoplasm; Oropharyngeal cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms XRAY VISION
  • Sponsors EMD Serono Research & Development Institute; Merck KGaA

Most Recent Events

  • 23 Sep 2024 Status changed from active, no longer recruiting to discontinued due to lack of evidence of meaningful clinical benefit. No major safety concerns were identified.
  • 18 Jul 2024 Planned End Date changed from 16 Dec 2030 to 30 Sep 2024.
  • 18 Jul 2024 Planned primary completion date changed from 5 Oct 2027 to 30 Sep 2024.

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