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NCT06866262 · ClinicalTrials.gov registry record · Phase 1
Inulin Gel in Combination With Ipilimumab and Nivolumab for the Treatment of Metastatic or Locally Advanced Kidney Cell Cancer, ICON Trial
A Phase 1 study of Stage IV Renal Cell Cancer AJCC v8 and Stage III Renal Cell Cancer AJCC v8, sponsored by University of Michigan Rogel Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT06866262: Recruiting Phase 1 study of Stage IV Renal Cell Cancer AJCC v8 and Stage III Renal Cell Cancer AJCC v8, sponsored by University of Michigan Rogel Cancer Center.
NCT06866262 is a Phase 1 study of Stage IV Renal Cell Cancer AJCC v8 and Stage III Renal Cell Cancer AJCC v8 that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 55 participants, below the 150-participant average among 24 other Stage IV Renal Cell Cancer AJCC v8 trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06866262, a Phase 1 study of Stage IV Renal Cell Cancer AJCC v8 and Stage III Renal Cell Cancer AJCC v8, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Will give an estimate and 95% confidence interval for the difference in the 6-month PFS rate between the combination arm and the single agent arm. This will be determined using binomial statistics. To allow for possible variability in the timing of the 6-month progression assessment, the 6-month PFS rate will be defined as the Kaplan-Meier estimate at 200 days after treatment initiation.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- BIOLOGICAL Ipilimumab
- DIETARY_SUPPLEMENT Inulin
Study Locations (1)
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2025-08-15 |
| Est. Completion | 2031-08-01 |
| Phase | Phase 1 |
What NCT06866262 shows while recruiting
NCT06866262 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 150-participant average among 24 other Stage IV Renal Cell Cancer AJCC v8 trials with a reported enrollment target (63% lower).
The record links to 6 conditions, with Stage IV Renal Cell Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06866262 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06866262 about?
NCT06866262 is a clinical study titled "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 s...
What is the current status of trial NCT06866262?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2025-08-15. Estimated completion is 2031-08-01.
What conditions does trial NCT06866262 study?
This clinical trial studies the following conditions: Stage IV Renal Cell Cancer AJCC v8, Stage III Renal Cell Cancer AJCC v8, Metastatic Clear Cell Renal Cell Carcinoma, Metastatic Sarcomatoid Renal Cell Carcinoma, Locally Advanced Clear Cell Renal Cell Carcinoma.
What interventions are being tested in trial NCT06866262?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Ipilimumab (BIOLOGICAL), Inulin (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06866262?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06866262 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06866262's enrollment target sits among peer trials
55 15th of 24 higher than 10 of 24 other Stage IV Renal Cell Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Renal Cell Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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