Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer

This phase III trial compares the effect of adding live biotherapy, MO-03, to standard of care (SOC) immunotherapy, including ipilimumab, nivolumab, axitinib, pembrolizumab, cabozantinib, and lenvatinib, to SOC immunotherapy alone in treating patients with clear cell renal cell cancer that may have spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started to other places in the body (metastatic). Studies have shown that gut health (the gut microbiome) may impact the effectiveness of im

Trial Details

NCT ID
NCT07383441
Phase
PHASE3
Sponsor
SWOG Cancer Research Network
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • Axitinib
  • Biospecimen Collection
  • Bone Scan
  • Cabozantinib
  • Clostridium butyricum CBM 588 Probiotic Strain
  • Computed Tomography
Locations (sample)
  • Fayetteville, Arkansas, United States|36.06258,-94.15743
  • Jonesboro, Arkansas, United States|35.8423,-90.70428
  • Rogers, Arkansas, United States|36.33202,-94.11854
  • Springdale, Arkansas, United States|36.18674,-94.12881
  • Bloomington, Illinois, United States|40.4842,-88.99369

Key Eligibility Criteria

  • Participants must have histologically confirmed renal cell carcinoma (RCC) with clear cell component that is advanced (not amenable to curative sur…
  • Participants must have measurable/evaluable disease by RECIST 1.1 criteria. Participants with only bone metastases or only pleural effusions are co…
  • Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease must not require immediate central nervou…
  • Participants must not be currently enrolled or plan to participate in treatment studies while enrolled on this study

For full eligibility, visit ClinicalTrials.gov.

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