Health Trials

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

ConditionsLocally Advanced Clear Cell Renal Cell CarcinomaLocally Advanced Sarcomatoid Renal Cell CarcinomaMetastatic Clear Cell Renal Cell CarcinomaMetastatic Sarcomatoid Renal Cell CarcinomaStage III Renal Cell Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan Rogel Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

Patient is ≥ 18 years of age on the day of signing informed consent.

Candidate for ipilimumab and nivolumab therapy for metastatic renal cancer per the treating physician investigator.

Patient has a performance status of ≤ 2 on the Zubrod performance scale.

Patient has a histological or cytological diagnosis of renal cancer with clear cell or sarcomatoid component.

Disqualifiers

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.

Patient is currently enrolled in another clinical trial testing another investigational agent, or concurrently in another approved systemic anti-cancer therapy for renal cancer.

Patient is on chronic systemic steroid therapy at doses > 10 mg/day prednisone equivalent or on any other immunosuppressive therapy within 7 days prior to day 1 of therapy. Exception-Replacement steroid doses for adrenal insufficiency are permitted as necessary.

Subjects with active and uncontrolled autoimmune disease. Subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll.

Trial design

Treatments tested in this trial

  • Biopsy
  • Biospecimen Collection
  • Computed Tomography
  • Inulin
  • Ipilimumab
  • Magnetic Resonance Imaging
  • Nivolumab
  • Questionnaire Administration

Treatment groups

55 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Michigan Rogel Cancer Center

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov