Phase III Study of Inulin Gel with Ipilimumab and Nivolumab for Advanced or Metastatic Kidney Cell Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of inulin gel combined with immunotherapy drugs ipilimumab and nivolumab for patients with metastatic or locally advanced kidney cell cancer, also called renal cell carcinoma RCC. This phase III trial focuses on cancers that have spread from their original site to other parts of the body or nearby tissues. The study explores whether inulin, a dietary fiber that supports a healthy gut microbiome, can improve the response to immune checkpoint inhibitors like ipilimumab and nivolumab, which help the immune system target cancer cells. Participants are randomly assigned to one of two groups. One group receives nivolumab and ipilimumab intravenously every 21 days for up to four cycles, followed by nivolumab alone every 28 days. The other group receives the same immunotherapy schedule plus inulin gel taken orally twice daily for up to 52 weeks, with the option to continue inulin beyond this period if beneficial. Throughout the study, patients undergo CT or MRI scans, blood sample collections, and may have biopsies during screening, treatment, and if disease progresses. During the trial, participants will be closely monitored with imaging tests and blood draws to assess treatment response and side effects. Researchers will measure progression-free survival at six months and track any adverse events related to inulin gel up to 30 days after the last dose. Secondary outcomes include overall response rate, progression-free survival over three years, and overall survival. The study will continue until August 2031, with ongoing assessments to evaluate the treatments impact and safety.

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