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Phase 2 Randomized Open-label Multicenter Study of Combination of ONC-392 and Pembrolizumab for the Treatment of Patients with Platinum Resistant Ovarian Cancer (PROC)

Trial Profile

Phase 2 Randomized Open-label Multicenter Study of Combination of ONC-392 and Pembrolizumab for the Treatment of Patients with Platinum Resistant Ovarian Cancer (PROC)

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

Latest Information Update: 12 Aug 2025

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At a glance

  • Drugs Gotistobart (Primary) ; Pembrolizumab (Primary)
  • Indications Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms PRESERVE-004
  • Sponsors OncoC4

Most Recent Events

  • 29 Jul 2025 Planned primary completion date changed from 30 Jun 2025 to 30 Oct 2025.
  • 04 Nov 2024 According to a BioNTech media release, In September 2024, preliminary data from this trial were presented at ESMO. The data suggest encouraging preliminary clinical activity and a manageable tolerability profile with no new safety signals detected for the combination.
  • 24 Oct 2024 Status changed from recruiting to active, no longer recruiting.

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