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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Of IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Checkpoint-Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma

Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Of IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Checkpoint-Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 23 Dec 2025

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At a glance

  • Drugs IFx 2.0 (Primary) ; Pembrolizumab (Primary)
  • Indications Merkel cell carcinoma
  • Focus Registrational; Therapeutic Use
  • Sponsors TuHURA Biosciences

Most Recent Events

  • 11 Dec 2025 According to TuHURA Biosciences media release, enrollment completion for this trial is targeted for Q4-2026.
  • 14 Oct 2025 Planned initiation date changed from 30 Jun 2025 to 1 Oct 2025.
  • 24 Jun 2025 According to TuHURA Biosciences media release, the company anticipates having more than half of the 22 participating sites open over the next 3-4 weeks, with the balance activated by the end of summer. The pivotal trial for IFx-2.0 is expected to enroll 118 participants across approximately 22 to 25 U.S. sites.

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