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Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery

Study acronym: FLORA-5
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 95 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Mar 26, 2026 to Dec 26, 2026 Site details revised at 5 of 148 sitesv95 Show 1 more changeShow less
    • Site details revised at 5 of 148 sites
  2. Primary completion date: Sep 26, 2025 to Mar 26, 2026 Completion date: Aug 26, 2027 to Aug 26, 2028v94 Show 1 more changeShow less
    • Completion date: Aug 26, 2027 to Aug 26, 2028
  3. Study sites: 150 to 148v93
  4. Study sites: 155 to 150v92
  5. Study sites: 161 to 155v91
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 166 to 161v90
  2. Study sites: 179 to 166v89
  3. Study sites: 187 to 179v88
  4. Primary completion date: Jun 26, 2024 to Sep 26, 2025 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 602 to confirmed 615 · Study sites: 193 to 187 · 4 morev87 Show 7 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 602 to confirmed 615
    • Study sites: 193 to 187
    • Interventions: Carboplatin (Drug), Oregovomab (Biological), Paclitaxel (Drug), Placebo (Biological) to Carboplatin (Drug), Carboplatin (Drug), Oregovomab (Biological), Paclitaxel (Drug), Placebo (Biological)
    • Eligibility criteria expanded, about 690 words
    • Secondary endpoints: 1 to 3
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 192 to 193v86
  6. Site details revised at 1 of 192 sitesv85
  7. Site details revised at 1 of 192 sitesv84
  8. Study sites: 191 to 192v83
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  25. Study sites: 151 to 154v66
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  27. Study sites: 148 to 150v64
  28. Study sites: 147 to 148v63
  29. Study sites: 146 to 147v62
  30. Study sites: 145 to 146v61
  31. Study sites: 136 to 145v60
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  45. Study sites: 109 to 111v46
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Study to compare the safety and efficacy of oregovomab versus placebo, administered in combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of subjects with newly diagnosed advanced ovarian cancer who have undergone optimal debulking.
Trial Details
NCT Number NCT04498117
Lead Sponsor CanariaBio Inc.
Collaborators: Gynecologic Oncology Group, IQVIA Pty Ltd
Conditions Carcinoma, Ovarian Epithelial, Ovarian Neoplasms, Ovarian Cancer, Ovarian Serous Adenocarcinoma, Fallopian Tube Neoplasms, Fallopian Tube Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Peritoneal Cancer +2 more
Enrollment 615 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov