Inulin Gel in Combination With Ipilimumab and Nivolumab for the Treatment of Metastatic or Locally Advanced Kidney Cell Cancer, ICON Trial

This phase I/II trial tests the safety and effectiveness of inulin gel in combination with ipilimumab and nivolumab in treating patients with kidney cell cancer (renal cell carcinoma \[RCC\]) that has spread from where it first started (primary site) to other places in the body (metastatic) or has spread to nearby tissue or lymph nodes (locally advanced). Inulin is a common food additive fermentable prebiotic fiber beneficial for a healthy gut microbiome. The microbiome is the collection of all microbes, such as bacteria, fungi, viruses, and their genes, that naturally live on and inside the b

Trial Details

NCT ID
NCT06866262
Phase
PHASE1 / PHASE2
Sponsor
University of Michigan Rogel Cancer Center
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • Biopsy
  • Biospecimen Collection
  • Computed Tomography
  • Inulin
  • Ipilimumab
  • Magnetic Resonance Imaging
Locations (sample)
  • Ann Arbor, Michigan, United States|42.27756,-83.74088

Key Eligibility Criteria

  • Patient is ≥ 18 years of age on the day of signing informed consent.
  • Candidate for ipilimumab and nivolumab therapy for metastatic renal cancer per the treating physician investigator.
  • Patient has a performance status of ≤ 2 on the Zubrod performance scale.
  • Patient has a histological or cytological diagnosis of renal cancer with clear cell or sarcomatoid component.

For full eligibility, visit ClinicalTrials.gov.

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