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Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Study acronym: COSMIC-313
StatusActive, Not Recruiting
PhasePhase 3
SponsorExelixis
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results first posted: Sep 10, 2025 Primary endpoint revised · Completion date: Jun 30, 2026 to Jan 31, 2027 · Secondary endpoints: details revised at 1 of 1 entryv44 Show 3 more changesShow less
    • Primary endpoint revised
    • Completion date: Jun 30, 2026 to Jan 31, 2027
    • Secondary endpoints: details revised at 1 of 1 entry

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Completed to Active, Not Recruiting Completion date: May 9, 2024 to Jun 30, 2026v43 Show 1 more changeShow less
    • Completion date: May 9, 2024 to Jun 30, 2026
  3. 2 versions Re-verified since Nov 7, 2024, no change to tracked fieldsv41-v42
  4. Trial status: Active, Not Recruiting to Completed Enrollment target: estimated 840 to confirmed 855 · Study completion date changed from estimate of Mar 2025 to May 9, 2024v40 Show 2 more changesShow less
    • Enrollment target: estimated 840 to confirmed 855
    • Study completion date changed from estimate of Mar 2025 to May 9, 2024
  5. Study sites: 160 to 159v39
Show 37 earlier versionsHide 37 earlier versions
  1. 2 versions Re-verified since Jan 23, 2023, no change to tracked fieldsv37-v38
  2. Study sites: 167 to 160 Primary completion date changed from estimate of Jun 2022 to Jan 31, 2022 · Eligibility criteria expanded, about 74 wordsv36 Show 2 more changesShow less
    • Primary completion date changed from estimate of Jun 2022 to Jan 31, 2022
    • Eligibility criteria expanded, about 74 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Nov 2021 to Jun 2022v35
  4. Trial status: Recruiting to Active, Not Recruiting Study sites: 177 to 167v34 Show 1 more changeShow less
    • Study sites: 177 to 167
  5. Site details revised at 9 of 177 sitesv33
  6. Trial status: Active, Not Recruiting to Recruiting Enrollment target: 676 to 840 · Study sites: 176 to 177 · Completion date: Jun 2024 to Mar 2025 · 2 morev32 Show 5 more changesShow less
    • Enrollment target: 676 to 840
    • Study sites: 176 to 177
    • Completion date: Jun 2024 to Mar 2025
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 1 of 1 entry

    See this version in full on ClinicalTrials.gov ↗

  7. Enrollment target: 737 to 676v31
  8. Enrollment target: 705 to 737v30
  9. Enrollment target: 675 to 705v29
  10. Study sites: 184 to 176v28
  11. Enrollment target: 658 to 675v27
  12. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 676 to confirmed 658 · Study sites: 185 to 184v26 Show 2 more changesShow less
    • Enrollment target: estimated 676 to confirmed 658
    • Study sites: 185 to 184
  13. Study sites: 187 to 185v25
  14. Study sites: 190 to 187v24
  15. Study sites: 189 to 190v23
  16. Study sites revised (189)v22 See this version in full on ClinicalTrials.gov ↗
  17. Study sites revised (189)v21 See this version in full on ClinicalTrials.gov ↗
  18. Study sites: 188 to 189v20
  19. Study sites revised (188)v19 See this version in full on ClinicalTrials.gov ↗
  20. Study sites: 185 to 188v18
  21. Study sites: 186 to 185v17
  22. Study sites: 185 to 186v16
  23. Study sites: 184 to 185 Eligibility criteria expanded, about 15 wordsv15 Show 1 more changeShow less
    • Eligibility criteria expanded, about 15 words

    See this version in full on ClinicalTrials.gov ↗

  24. Study sites revised (184)v14 See this version in full on ClinicalTrials.gov ↗
  25. Study sites revised (184)v13 See this version in full on ClinicalTrials.gov ↗
  26. Study sites: 168 to 184v12
  27. Study sites: 166 to 168v11
  28. Study sites: 167 to 166v10
  29. Study sites: 166 to 167v9
  30. Site details revised at 2 of 166 sitesv8
  31. Study sites: 162 to 166v7
  32. Study sites: 133 to 162v6
  33. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 2019 to Jun 25, 2019 · Study sites revised (133)v5 Show 2 more changesShow less
    • Start date changed from estimate of Jun 2019 to Jun 25, 2019
    • Study sites revised (133)

    See this version in full on ClinicalTrials.gov ↗

  34. Study sites: 121 to 133v4
  35. Study sites: 80 to 121v3
  36. Re-verified, no change to tracked fieldsv2
  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.
Exelixis
25 trials monitored
See 2 trials at risk
Kidney Cancer
772 trials monitored
See 53 trials at risk
This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio at approximately 180 sites.
Trial Details
NCT Number NCT03937219
Lead Sponsor Exelixis
Conditions Renal Cell Carcinoma
Enrollment 855 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov