ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer

Study acronym: PRESERVE-004
StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Study completion pushed from Aug 30, 2026 to Aug 30, 2027 Show 4 more changesShow less
    • Eligibility criteria expanded, about 37 words
    • Site details revised at 2 of 21 sites
    • Collaborators: details revised at 1 of 2 entries
    • Publications: details revised at 4 of 4 entries
  2. Primary completion date: Oct 30, 2025 to Aug 30, 2026
    • Study completion date: Jun 30, 2026 to Aug 30, 2026
    v13
  3. Primary completion date: Jun 30, 2025 to Oct 30, 2025v12
  4. Publications: 2 to 4v11
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 21 of 21 sites
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. 2 versions Re-verified since Jan 8, 2024, no change to tracked fieldsv8-v9
  2. Site details revised at 8 of 21 sitesv7
  3. Study sites: 19 to 21v6
  4. Site details revised at 6 of 19 sites
    • Eligibility criteria shortened, about 4 words
    v5
  5. Study sites: 20 to 19
    • Eligibility criteria shortened, about 19 words
    v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 30, 2022 to Dec 22, 2022
    • Site details revised at 20 of 20 sites
    v3
  7. Start date: Sep 15, 2022 to Dec 30, 2022v2 Show 4 more changesShow less
    • Study sites: 0 to 20
    • Primary completion date: Sep 15, 2025 to Jun 30, 2025
    • Study completion date: Sep 15, 2026 to Jun 30, 2026
    • Publications: details revised at 2 of 2 entries
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
OncoC4, Inc.
9 trials monitored
See 2 trials at risk
Ovarian Cancer
1,346 trials monitored
See 97 trials at risk
This is a study to test the safety and efficacy with the combination of a next generation anti-CTLA-4 antibody, ONC-392, and anti-PD-1 antibody, pembrolizumab, in platinum resistant ovarian cancer patients.
Trial Details
NCT Number NCT05446298
Lead Sponsor OncoC4, Inc.
Collaborators: Merck Sharp & Dohme LLC, GOG Foundation
Conditions
(from sponsor)		 Ovarian Cancer, High Grade Serous Adenocarcinoma of Ovary, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
Related terms Fallopian Tube Neoplasms, Ovarian Neoplasms
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov