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Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 52 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Study sites: 32 to 33v52
  2. Primary completion pushed from Jun 2026 to Dec 2026
    • Study completion pushed from Oct 2026 to Dec 2027
    • Study sites: 31 to 32
    v51
  3. Site contacts updated at 6 of 31 sitesv50
  4. Study sites: 30 to 31v49
  5. Study sites: 31 to 30v48
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 30 to 31v47
  2. Primary completion date: Aug 2025 to Jun 2026
    • Study sites: 31 to 30
    v46
  3. Site contacts updated at 1 of 31 sitesv45
  4. Site contacts updated at 15 of 31 sitesv44
  5. Site contacts updated at 1 of 31 sitesv43
  6. Study sites: 30 to 31v42
  7. Site details revised at 4 of 30 sitesv41
  8. Eligibility criteria shortened, about 37 words
    • Site contacts updated at 2 of 30 sites
    v40
  9. Study sites: 28 to 30v39
  10. Study sites: 26 to 28v38
  11. Study sites: 24 to 26v37
  12. Study sites: 25 to 24v36
  13. Site contacts updated at 3 of 25 sitesv35
  14. Study sites: 24 to 25v34
  15. Site contacts updated at 24 of 24 sites
    • Publications: details revised at 3 of 5 entries
    v33
  16. Study sites: 23 to 24
    • Publications: details revised at 3 of 5 entries
    v32
  17. Study title expanded, about 1 wordv31
  18. Re-verified, no change to tracked fieldsv30
  19. Study sites: 22 to 23
    • Study description expanded, about 8 words
    • Eligibility criteria expanded, about 5 words
    • Study title expanded, about 3 words
    v29
  20. Primary completion date: Aug 2024 to Aug 2025
    • Study sites: 21 to 22
    v28
  21. Study sites: 20 to 21v27
  22. Study sites: 19 to 20v26
  23. Study sites: 18 to 19v25
  24. Study sites: 17 to 18v24
  25. Study sites: 15 to 17v23
  26. Study sites: 14 to 15v22
  27. Study sites: 12 to 14v21
  28. Study sites: 11 to 12v20
  29. Study sites: 9 to 11v19
  30. Study sites: 8 to 9v18
  31. Study sites: 7 to 8v17
  32. Study sites: 6 to 7v16
  33. Study description expanded, about 13 wordsv15
  34. Study sites: 5 to 6v14
  35. Study sites: 4 to 5
    • Publications: 4 to 5
    v13
  36. Study sites: 3 to 4v12
  37. Study sites: 2 to 3v11
  38. Study sites: 1 to 2v10
  39. Start date changed from estimate of Aug 2022 to Aug 31, 2022
    • Study title expanded, about 2 words
    v9
  40. Study sites: 2 to 1v8
  41. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v7
  42. Re-verified, no change to tracked fieldsv6
  43. Start date: Jun 2022 to Aug 2022v5
  44. Study sites: 1 to 2v4
  45. Start date: Apr 2022 to Jun 2022
    • Site contact updated
    v3
  • 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.
The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with Physician's Choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant/refractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer). This Phase III trial builds on the efficacy and safety data reported in the previous Phase II VIRO-15 trial with promising objective response rate and progression-free survival observed in heavily pre-treated patients with platinum-resistant/refractory ovarian cancer. The phase II results also showed that the intra-peritoneal route of delivery was efficient in generating tumor cell killing and immune activation, and led to clinical reversal of platinum-resistance or refractoriness in this difficult-to-treat patient population.
Trial Details
NCT Number NCT05281471
Lead Sponsor Genelux Corporation
Collaborators: GOG Foundation
Conditions
(from sponsor)		 Platinum-resistant Ovarian Cancer, Platinum-refractory Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, High-grade Serous Ovarian Cancer, Endometrioid Ovarian Cancer, Ovarian Clear Cell Carcinoma
Related terms Fallopian Tube Neoplasms, Ovarian Neoplasms, Vaccinia
Enrollment 186 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov