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Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial

Study acronym: PROBE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 35 words Secondary endpoints: details revised at 2 of 4 entries · Site details revised at 28 of 387 sites · Publications: details revised at 2 of 2 entries Show 3 more changesShow less
    • Secondary endpoints: details revised at 2 of 4 entries
    • Site details revised at 28 of 387 sites
    • Publications: details revised at 2 of 2 entries
  2. 2 versions Re-verified since Aug 14, 2024, no change to tracked fieldsv13-v14
  3. Study sites: 224 to 387v12
  4. Start date: Nov 16, 2020 to Mar 8, 2021v11
  5. Re-verified, no change to tracked fieldsv10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 184 to 224v9
  2. Study sites: 179 to 184v8
  3. Study sites: 170 to 179v7
  4. Study sites: 164 to 170v6
  5. Study sites: 153 to 164v5
  6. Study sites: 61 to 153v4
  7. Trial status: Not Yet Recruiting to Recruiting Study sites: 7 to 61 · Start date changed from estimate of Dec 16, 2020 to Nov 16, 2020v3 Show 2 more changesShow less
    • Study sites: 7 to 61
    • Start date changed from estimate of Dec 16, 2020 to Nov 16, 2020
  8. Study sites: 0 to 7 Start date: Jan 2021 to Dec 16, 2020v2 Show 1 more changeShow less
    • Start date: Jan 2021 to Dec 16, 2020
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.
Trial Details
NCT Number NCT04510597
Lead Sponsor SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI)
Conditions Metastatic Clear Cell Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
Enrollment 364 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov