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

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 cel

Trial Details

NCT ID
NCT04510597
Phase
PHASE3
Sponsor
SWOG Cancer Research Network
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • Cytoreductive Nephrectomy
  • Active Comparator
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Fort Smith, Arkansas, United States|35.38592,-94.39855
  • Arroyo Grande, California, United States|35.11859,-120.59073

Key Eligibility Criteria

  • STEP 1 REGISTRATION: Participants must have a histologically proven diagnosis of clear cell or non-clear cell renal cell carcinoma. Participants wi…
  • STEP 1 REGISTRATION: Participants must have primary tumor in place
  • STEP 1 REGISTRATION: Participants must have the following scans performed, showing clinical evidence of measurable or non-measurable metastatic dis…
  • Computed tomography (CT) scan of the chest (can be performed without contrast if CT contrast cannot be given)

For full eligibility, visit ClinicalTrials.gov.

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