Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study

StatusActive, Not Recruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 36 days later Jan 25, 2028 → Mar 1, 2028
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Record History

The 50 most recent of 771 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jan 25, 2028 to Mar 1, 2028
  2. Study sites revised (859)
  3. Re-verified, no change to tracked fieldsv769
  4. Study sites revised (859)v768
  5. Study sites: 860 to 859v767
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites revised (860)v766
  2. Study sites revised (860)v765
  3. Study sites revised (860)v764
  4. Study sites: 861 to 860v763
  5. Study sites revised (861)v762
  6. Re-verified, no change to tracked fieldsv761
  7. Study sites: 862 to 861v760
  8. 28 versions Re-verified since Mar 3, 2026, no change to tracked fieldsv732-v759
  9. Primary and study completion dates: Sep 15, 2026 to Jan 25, 2028v731
  10. Study sites revised (862)v730
  11. Re-verified, no change to tracked fieldsv729
  12. Study sites: 864 to 862v728
  13. Study sites revised (864)v727
  14. Study sites revised (864)v726
  15. Primary and study completion dates: Sep 15, 2025 to Sep 15, 2026v725
  16. 2 versions Re-verified since Aug 29, 2025, no change to tracked fieldsv723-v724
  17. Study sites revised (864)v722
  • 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.
This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with renal cell cancer that has spread to other parts of the body.
Trial Details
NCT Number NCT03793166
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Clear Cell Renal Cell Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Neoplasm in the Lymph Nodes, Metastatic Malignant Neoplasm in the Soft Tissue, Metastatic Malignant Neoplasm in the Viscera, Rhabdoid Tumor of the Kidney, Sarcomatoid Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8 +1 more
Related terms Carcinoma, Renal Cell, Lymphatic Metastasis
Enrollment 1,175 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov