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Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer

Study acronym: RAINFOL-02
StatusActive, Not Recruiting
PhasePhase 3
SponsorGenmab
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Final enrollment: 584 participants (planned 530) Primary completion date changed from estimate of Feb 2027 to Aug 18, 2026 · Completion moved earlier from May 23, 2028 to Oct 2027 · Eligibility criteria expanded, about 20 words · 2 more Show 5 more changesShow less
    • Primary completion date changed from estimate of Feb 2027 to Aug 18, 2026
    • Completion moved earlier from May 23, 2028 to Oct 2027
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 2 of 10 entries
    • Site details revised at 16 of 177 sites
  2. Minor Site details revised at 3 of 177 sitesv25
  3. Minor Secondary endpoints: 11 to 10 Site details revised at 2 of 177 sitesv24 Show 1 more changeShow less
    • Site details revised at 2 of 177 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Site details revised at 2 of 177 sitesv23
  5. Minor Enrollment increased: 448 → 530 participants Site details revised at 2 of 177 sitesv22 Show 1 more changeShow less
    • Site details revised at 2 of 177 sites
  6. Minor Site details revised at 2 of 177 sitesv21
  7. Minor Enrollment reduced: 530 → 448 participants Study description expanded, about 9 wordsv20 Show 1 more changeShow less
    • Study description expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  8. Minor Eligibility criteria expanded, about 9 words Secondary endpoints: details revised at 10 of 11 entriesv19 Show 1 more changeShow less
    • Secondary endpoints: details revised at 10 of 11 entries

    See this version in full on ClinicalTrials.gov ↗

  9. Minor Re-verified, no change to tracked fieldsv18
  10. Minor Trial status: Recruiting to Active, Not Recruiting Study sites: 175 to 177v17 Show 1 more changeShow less
    • Study sites: 175 to 177
  11. Minor Study sites: 173 to 175v16
  12. Minor Study sites: 162 to 173v15
  13. Minor Study sites: 144 to 162v14
  14. Minor Study sites: 83 to 144v13
  15. Minor Re-verified, no change to tracked fieldsv12
  16. Minor Study sites: 68 to 83 Primary completion date: May 2, 2027 to Feb 2027 · Completion date: Apr 5, 2028 to May 23, 2028 · Secondary endpoints: details revised at 10 of 11 entries · 1 morev11 Show 4 more changesShow less
    • Primary completion date: May 2, 2027 to Feb 2027
    • Completion date: Apr 5, 2028 to May 23, 2028
    • Secondary endpoints: details revised at 10 of 11 entries
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  17. Minor Study sites: 38 to 68 Eligibility criteria expanded, about 28 words · Secondary endpoints: 9 to 11v10 Show 2 more changesShow less
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: 9 to 11

    See this version in full on ClinicalTrials.gov ↗

  18. Minor Study sites: 21 to 38v9
  19. Minor Study sites: 19 to 21v8
  20. Minor Study sites: 4 to 19v7
  21. Minor Study sites: 2 to 4 Start date changed from estimate of Feb 2025 to Feb 7, 2025v6 Show 1 more changeShow less
    • Start date changed from estimate of Feb 2025 to Feb 7, 2025
  22. Notable Trial status: Not Yet Recruiting to Recruiting Site details revised at 2 of 2 sitesv5 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  23. Notable Start date: Dec 15, 2024 to Feb 2025 Study sites: 0 to 2 · Primary completion date: Feb 2027 to May 2, 2027 · Completion date: Nov 30, 2029 to Apr 5, 2028 · 2 morev4 Show 5 more changesShow less
    • Study sites: 0 to 2
    • Primary completion date: Feb 2027 to May 2, 2027
    • Completion date: Nov 30, 2029 to Apr 5, 2028
    • Eligibility criteria expanded, about 90 words
    • Secondary endpoints revised (9)

    See this version in full on ClinicalTrials.gov ↗

  24. Notable Start date: Oct 22, 2024 to Dec 15, 2024v3
  25. Minor Start date: Sep 25, 2024 to Oct 22, 2024v2
  26. Minor 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.
45 trials monitored
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1,245 trials monitored
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This phase 3 study will be conducted in different countries all over the world. The purpose of this study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer. Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose. All participants will receive active drug; no one will be given placebo.
Trial Details
NCT Number NCT06619236
Lead Sponsor Genmab
Conditions Platinum-resistant Ovarian Cancer
Enrollment 584 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov