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A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients

StatusWithdrawn
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Withdrawn before enrolling Sponsor's reason: Sponsor Decision Enrollment target: estimated 24 to confirmed 0 · Study sites: 2 to 0 · Eligibility criteria expanded, about 44 words Show 3 more changesShow less
    • Enrollment target: estimated 24 to confirmed 0
    • Study sites: 2 to 0
    • Eligibility criteria expanded, about 44 words
  2. Primary completion date: Nov 2026 to Nov 2027 Start date: Jan 2026 to Sep 2026 · Completion date: Nov 2027 to Nov 2028v15 Show 2 more changesShow less
    • Start date: Jan 2026 to Sep 2026
    • Completion date: Nov 2027 to Nov 2028
  3. Primary completion date: Nov 2025 to Nov 2026 Start date: Jan 2025 to Jan 2026 · Completion date: Nov 2026 to Nov 2027 · Site contacts updated at 2 of 2 sitesv14 Show 3 more changesShow less
    • Start date: Jan 2025 to Jan 2026
    • Completion date: Nov 2026 to Nov 2027
    • Site contacts updated at 2 of 2 sites
  4. Start date: Oct 2024 to Jan 2025 Trial status: Recruiting to Not Yet Recruiting · Site details revised at 2 of 2 sites · Collaborators: 2 to 1v13 Show 3 more changesShow less
    • Trial status: Recruiting to Not Yet Recruiting
    • Site details revised at 2 of 2 sites
    • Collaborators: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Suspended to Recruiting Start date: Aug 2024 to Oct 2024 · Site details revised at 2 of 2 sitesv12 Show 2 more changesShow less
    • Start date: Aug 2024 to Oct 2024
    • Site details revised at 2 of 2 sites
Show 10 earlier versionsHide 10 earlier versions
  1. Start date: Jun 2024 to Aug 2024 Interventions: NY-ESO-1 Peptide vaccine (Biological), Nivolumab (Drug) to NY-ESO-1 Peptide vaccine (Biological), Toripalimab-tpzi (Drug) · Collaborators: 1 to 2v11 Show 2 more changesShow less
    • Interventions: NY-ESO-1 Peptide vaccine (Biological), Nivolumab (Drug) to NY-ESO-1 Peptide vaccine (Biological), Toripalimab-tpzi (Drug)
    • Collaborators: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Recruiting to Suspended Sponsor's reason: Protocol Amendment pending Primary completion date: Nov 2024 to Nov 2025 · Start date: Dec 2023 to Jun 2024 · Study sites: 3 to 2 · 2 morev10 Show 5 more changesShow less
    • Primary completion date: Nov 2024 to Nov 2025
    • Start date: Dec 2023 to Jun 2024
    • Study sites: 3 to 2
    • Completion date: Nov 2025 to Nov 2026
    • Collaborators: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Nov 2023 to Dec 2023v9
  4. Start date: Sep 2023 to Nov 2023v8
  5. Trial status: Not Yet Recruiting to Recruiting Start date: Jul 2023 to Sep 2023 · Site details revised at 3 of 3 sitesv7 Show 2 more changesShow less
    • Start date: Jul 2023 to Sep 2023
    • Site details revised at 3 of 3 sites
  6. Start date: Mar 2023 to Jul 2023v6
  7. Collaborators: 1 to 2v5 See this version in full on ClinicalTrials.gov ↗
  8. Start date: Nov 2022 to Mar 2023v4
  9. Re-verified, no change to tracked fieldsv3
  10. Eligibility criteria expanded, about 4 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
This is an open label, non-randomized, 2-stage phase II, single arm study to determine the efficacy of New York esophageal squamous cell carcinoma 1 (NY-ESO-1) peptide vaccine as a priming mechanism to prevent anti-PD1 resistance in patients with platinum-refractory stage III/IV ovarian cancer (OC).
Trial Details
NCT Number NCT05479045
Lead Sponsor Georgetown University
Collaborators: Coherus Oncology, Inc.
Conditions Ovarian Cancer Stage IV, Ovarian Cancer Stage III, Ovarian Cancer Stage 3
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov