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

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv7
  2. Eligibility criteria shortened, about 8 wordsv6
  3. Primary and study completion dates: Sep 1, 2031 to Aug 1, 2031
    • Start date changed from estimate of Sep 1, 2025 to Aug 15, 2025
    v5
  4. Start date: Jul 1, 2025 to Sep 1, 2025
    • Primary and study completion dates: Jul 1, 2031 to Sep 1, 2031
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 1, 2025 to Jul 1, 2025
    • Primary and study completion dates: Jun 1, 2031 to Jul 1, 2031
    • Site details revised
    v3
  6. Start date: Apr 1, 2025 to Jun 1, 2025
    • Primary and study completion dates: Apr 1, 2031 to Jun 1, 2031
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 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 body. Inulin may also be used for cancer prevention and heart health, but there is less evidence to support those uses. The gut microbiome profile may improve the effectiveness of drugs called immune checkpoint inhibitors, such as ipilimumab and nivolumab. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving inulin gel in combination with ipilimumab and nivolumab may be safe and effective in treating in patients with metastatic or locally advanced RCC.
Trial Details
NCT Number NCT06866262
Lead Sponsor University of Michigan Rogel Cancer Center
Collaborators: United States Department of Defense
Conditions
(from sponsor)		 Locally Advanced Clear Cell Renal Cell Carcinoma, Locally Advanced Sarcomatoid Renal Cell Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma, Metastatic Sarcomatoid Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8
Related terms Carcinoma, Renal Cell, Clear-cell metastatic renal cell carcinoma
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov