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An Open-label, Randomized, Phase 3 Clinical Trial of IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Patients With Previously Untreated, Unresectable, or Metastatic (Advanced) Melanoma (IO102-IO103-013 / MK3475-D18)

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Trial Profile

An Open-label, Randomized, Phase 3 Clinical Trial of IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Patients With Previously Untreated, Unresectable, or Metastatic (Advanced) Melanoma (IO102-IO103-013 / MK3475-D18)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Jun 2024

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At a glance

  • Drugs IO102 IO103 (Primary) ; Pembrolizumab (Primary)
  • Indications Malignant melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-D18
  • Sponsors IO Biotech
  • Most Recent Events

    • 13 Mar 2024 This trial has been completed in Portugal, according to European Clinical Trials Database record.
    • 13 Nov 2023 According to an IO Biotech media release, the PFS analysis will be conducted when 226 events have occurred in the trial, which the company estimates will take place in the second half of 2025. Additionally, there is a per-protocol interim analysis of overall response rate (ORR) planned when the first 225 randomized patients reach one -year of treatment in June 2024. The outcome of this analysis is expected in the third quarter of 2024.
    • 13 Nov 2023 Status changed from recruiting to active, no longer recruiting, according to a IO Biotech media release.
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