Actively Recruiting
Phase I/II Trial of Inulin Gel Combined With Ipilimumab and Nivolumab for Advanced Renal Cell Carcinoma
Led by University of Michigan Rogel Cancer Center · Updated on 2025-09-09
55
Participants Needed
1
Research Sites
N/A
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 trial investigates the safety and effectiveness of adding inulin gel to the immunotherapy drugs ipilimumab and nivolumab in treating patients with kidney cell cancer that has spread to other parts of the body or nearby tissues. Inulin is a common dietary fiber that may benefit the gut microbiome, which in turn could improve how well immune checkpoint inhibitors work against cancer. The study is a phase I/II clinical trial focusing on advanced or metastatic renal cell carcinoma. Participants are randomly assigned to one of two groups. One group receives ipilimumab and nivolumab intravenously every 21 days for up to four cycles, then nivolumab alone every 28 days. The other group receives the same immunotherapy schedule plus inulin gel taken orally twice daily for 52 weeks, with the option to continue beyond that if beneficial. Throughout the study, patients undergo CT or MRI scans and blood sample collections, with optional biopsies at screening, during treatment, and at disease progression. Participants will be monitored for disease progression and any side effects related to the treatments. The main outcomes measured include progression-free survival at six months and the incidence of adverse events related to inulin gel within 30 days after the last dose. Secondary outcomes include overall response rate, overall survival, and longer-term progression-free survival assessed up to three years. The total study duration and safety follow-up extend until disease progression or unacceptable toxicity occurs.
CONDITIONS
Brief 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 treating physician.
- Performance status of 2 or less on the Zubrod performance scale.
- Histological or cytological diagnosis of renal cancer with clear cell or sarcomatoid component.
- Radiologic or clinical evidence of metastatic disease or progressive locally advanced disease.
- Absolute neutrophil count of at least 1,500/uL.
- Platelets 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 levels less than or equal to 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.
- Evaluable or measurable disease as defined by RECIST 1.1 criteria.
- Ability to understand and willing to sign informed consent.
- Both male and female patients agree to use adequate contraception during study 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 therapy.
You will not qualify if you...
- Received cytotoxic therapy, biologic agents, or immunosuppressants (excluding steroids) within 4 weeks before starting therapy, or antibiotics within 2 weeks.
- Currently enrolled in another clinical trial testing another investigational agent or 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.
- Active and uncontrolled autoimmune disease, except certain controlled conditions.
- New or progressive brain metastases requiring immediate CNS treatment.
- Condition, therapy, or lab abnormality that may interfere with study participation or safety.
- Known psychiatric or substance abuse disorders interfering with trial cooperation.
- Pregnant or lactating patients not agreeing to discontinue breastfeeding.
- History of other metastatic or relapsed active malignancy, except localized skin cancers.
- Intractable nausea and vomiting despite therapy.
- Hypersensitivity to ipilimumab, nivolumab, inulin, or formulation excipients.
- Known malabsorption disorder.
- Use of probiotics or antibiotics during study.
- History of colectomy or gastric bypass.
- Active inflammatory bowel disease or irritable bowel syndrome.
- History of organ or stem cell/bone marrow transplant.
- Active Clostridium difficile infection within 3 months before therapy start.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks or longer depending on treatment response and tolerance
Participants receive intravenous nivolumab and ipilimumab on day 1 of each 21-day cycle for up to 4 cycles, followed by nivolumab monotherapy on day 1 of each 28-day cycle starting from cycle 5. Participants in one group also take inulin gel by mouth twice daily for up to 52 weeks and may continue longer if beneficial and tolerated. Throughout treatment, participants undergo CT or MRI scans and blood sample collections. Optional biopsies may be performed during treatment and at disease progression.
Visits every 21 days for up to 4 cycles, then every 28 days thereafter; ongoing imaging and blood sample collection visits; optional biopsy visits
Duration - Up to 30 days after last dose of treatment
Participants are monitored for adverse events and disease outcomes after treatment ends.
1 to 2 visits depending on follow-up needs
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
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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