Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Trial sites expanded: 176 → 183 locations
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Publications: details revised at 1 of 1 entry
  2. Trial sites expanded: 159 → 176 locationsv20
  3. Trial sites expanded: 134 → 159 locationsv19
  4. Trial sites expanded: 118 → 134 locationsv18
  5. Trial sites expanded: 97 → 118 locationsv17
  6. Trial sites expanded: 44 → 97 locationsv16
  7. Eligibility criteria expanded, about 4 wordsv15
  8. Trial sites expanded: 29 → 44 locationsv14
  9. Study sites: 28 to 29v13
  10. Study sites: 17 to 28v12
  11. Study sites: 12 to 17v11
  12. Study sites: 10 to 12v10
  13. Study sites: 9 to 10v9
  14. Site details revised at 8 of 9 sitesv8
  15. Study sites: 5 to 9v7
  16. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2025 to Sep 8, 2025
    • Site details revised at 5 of 5 sites
    v6
  17. Study sites: 0 to 5v5
  18. Start date: Aug 2025 to Sep 2025v4
  19. Start date: Jul 2025 to Aug 2025v3
  20. Study title shortened, about 3 wordsv2
  21. Study First Submitted
  • 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 purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan versus placebo when each is given in combination with cabozantinib in adult patients with confirmed advanced or metastatic clear cell Renal Cell Carcinoma who have experienced progression on or after prior anti-PD-1 or anti-PD-L1 immunotherapy.
Trial Details
NCT Number NCT07011719
Lead Sponsor Arcus Biosciences, Inc.
Conditions
(from sponsor)		 Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma
Related terms Clear-cell metastatic renal cell carcinoma, Kidney Neoplasms
Enrollment 720 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov