OncoMatch/Clinical Trials/NCT06866262
Inulin Gel in Combination With Ipilimumab and Nivolumab for the Treatment of Metastatic or Locally Advanced Kidney Cell Cancer, ICON Trial
Is NCT06866262 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Ipilimumab and Nivolumab for locally advanced clear cell renal cell carcinoma.
Treatment: Ipilimumab · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Disease stage
Required: Stage III, IV
Performance status
ZUBROD 0–2
Prior therapy
Cannot have received: systemic anti-cancer therapy
Exception: adjuvant/neoadjuvant therapy for non-metastatic disease not explicitly excluded
Patient received no prior systemic anti-cancer therapy for metastatic disease.
Cannot have received: cytotoxic chemotherapy
The subject has received cytotoxic therapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) or immunosuppressants (excluding steroids) within 4 weeks or antibiotics within 2 weeks of starting study therapy.
Cannot have received: biologic agent
The subject has received cytotoxic therapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) or immunosuppressants (excluding steroids) within 4 weeks or antibiotics within 2 weeks of starting study therapy.
Cannot have received: immunosuppressant
Exception: excluding steroids
The subject has received cytotoxic therapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) or immunosuppressants (excluding steroids) within 4 weeks or antibiotics within 2 weeks of starting study therapy.
Cannot have received: antibiotic
The subject has received ... antibiotics within 2 weeks of starting study therapy.
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/uL. Platelets ≥ 75K/μL. Hemoglobin ≥ 8.5 g/dL.
Kidney function
Calculated creatinine clearance is ≥ 30 ml/min as per the Cockroft-Gault formula.
Liver function
Direct bilirubin ≤ 1.5 x ULN OR total bilirubin levels ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 ULN. AST/ALT ≤ 3 x ULN except for patients with liver metastases, AST/ALT should be ≤ 5 x ULN.
Absolute neutrophil count ≥ 1,500/uL. Platelets ≥ 75K/μL. Hemoglobin ≥ 8.5 g/dL. Calculated creatinine clearance is ≥ 30 ml/min as per the Cockroft-Gault formula. Direct bilirubin ≤ 1.5 x ULN OR total bilirubin levels ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 ULN. AST/ALT ≤ 3 x ULN except for patients with liver metastases, AST/ALT should be ≤ 5 x ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Michigan Comprehensive Cancer Center · Ann Arbor, Michigan
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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