Actively Recruiting
Inulin Gel in Combination With Ipilimumab and Nivolumab for the Treatment of Metastatic or Locally Advanced Kidney Cell Cancer, ICON Trial
Led by University of Michigan Rogel Cancer Center · Updated on 2025-09-09
55
Participants Needed
1
Research Sites
311 weeks
Total Duration
On this page
Sponsors
U
University of Michigan Rogel Cancer Center
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Inulin Gel in Combination With Ipilimumab and Nivolumab for the Treatment of Metastatic or Locally Advanced Kidney Cell Cancer, ICON Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older on the day of signing informed consent.
- Candidate for ipilimumab and nivolumab therapy for metastatic renal cancer as determined by the treating physician.
- Patient has a performance status of 2 or less on the Zubrod scale.
- Patient has a histological or cytological diagnosis of renal cancer with clear cell or sarcomatoid components.
- Radiologic or clinical evidence of metastatic disease or progressive locally advanced disease.
- Absolute 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.
- Calculated creatinine clearance of at least 30 ml/min.
- Direct bilirubin less than or equal to 1.5 times the upper limit of normal (ULN), or total bilirubin less than or equal to 1.5 times ULN, or direct bilirubin less than or equal to ULN if total bilirubin is above 1.5 times ULN.
- AST/ALT levels less than or equal to 3 times ULN, or less than or equal to 5 times ULN for patients with liver metastases.
- No prior systemic anti-cancer therapy for metastatic disease.
- Patient has evaluable or measurable disease as defined by RECIST 1.1 criteria.
- Ability to understand and willingness to sign written informed consent.
- Agreement to use adequate contraceptive measures during therapy and for at least 5 months after stopping therapy.
- Ability to take oral therapy.
- Female patients of childbearing potential have a negative pregnancy test within 7 days before starting study therapy.
You will not qualify if you...
- Received cytotoxic therapy, biologic agents, or immunosuppressants (excluding steroids) within 4 weeks, or antibiotics within 2 weeks before starting therapy.
- Currently enrolled in another clinical trial testing an investigational agent or receiving another approved systemic anti-cancer therapy for renal cancer.
- On chronic systemic steroid therapy above 10 mg/day prednisone equivalent or other immunosuppressive therapy within 7 days prior to therapy start, except replacement steroids for adrenal insufficiency.
- Have active and uncontrolled autoimmune disease, except certain controlled conditions.
- Have new or progressive brain metastases requiring immediate treatment.
- Have conditions or treatments that could interfere with study participation or results.
- Have psychiatric or substance abuse disorders impacting trial cooperation.
- Are pregnant, breastfeeding, or planning sperm or breast milk donation during and for 5 months after therapy.
- History of another metastatic or relapsed active malignancy (except localized skin cancers).
- Have intractable nausea and vomiting not controlled by antiemetics.
- History of hypersensitivity to ipilimumab, nivolumab, inulin, or their components.
- Diagnosed with malabsorption disorder.
- Concurrent use of probiotics or antibiotics.
- History of colectomy or gastric bypass surgery.
- Known active inflammatory bowel disease or irritable bowel syndrome.
- History of organ transplant or stem cell/bone marrow transplant.
- Active Clostridium difficile infection within 3 months before therapy start.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
C
Cancer AnswerLine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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