Study on Inulin Gel with Ipilimumab and Nivolumab for Treating Advanced Kidney Cancer (ICON Trial)

Inclusion Criteria

• Must be 18 years or older.
• Eligible for treatment with ipilimumab and nivolumab for metastatic kidney cancer.
• Have a performance status score of 2 or less, indicating ability to carry out daily activities.
• Diagnosed with kidney cancer that includes clear cell or sarcomatoid components.
• Have evidence of cancer that has spread or is locally advanced.
• Meet specific blood count and organ function requirements, such as:
  • Neutrophil count of at least 1,500/uL.
  • Platelet count of at least 75,000/μL.
  • Hemoglobin level of at least 8.5 g/dL.
  • Kidney function with creatinine clearance of at least 30 ml/min.
  • Liver function within specified limits.
• No prior treatment for metastatic disease, but previous adjuvant therapy is allowed if completed 6 months before starting the study.
• Have measurable or evaluable disease based on specific criteria.
• Able to understand and sign informed consent.
• Agree to use effective contraception during and for 5 months after treatment.
• Able to take oral medication.
• Women of childbearing potential must have a negative pregnancy test before starting treatment.

Exclusion Criteria

• Have received certain cancer treatments or antibiotics recently.
• Currently participating in another clinical trial or receiving other cancer treatments.
• On high-dose steroids or other immunosuppressive medications recently.
• Have uncontrolled autoimmune diseases, except for certain stable conditions.
• Have untreated or unstable brain metastases.
• Have conditions or treatments that could interfere with the study.
• Have psychiatric or substance abuse issues affecting participation.
• Pregnant or breastfeeding, or planning to donate sperm or breast milk during and after treatment.
• Have another active cancer, except for certain skin cancers.
• Have severe nausea and vomiting not controlled by medication.
• Allergic to study drugs or their components.
• Have malabsorption disorders or use probiotics or antibiotics.
• Have had certain surgeries like colectomy or gastric bypass.
• Have inflammatory bowel disease or irritable bowel syndrome.
• Have had an organ or stem cell transplant.
• Have a recent Clostridium difficile infection.