Inulin Gel in Combination With Ipilimumab and Nivolumab for the Treatment of Metastatic or Locally Advanced Kidney Cell Cancer, ICON Trial
NCT ID: NCT06866262
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
55 participants
INTERVENTIONAL
2025-08-15
2031-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (nivolumab, ipilimumab)
Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning in cycle 5, patients receive nivolumab monotherapy IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and blood sample collection throughout the study. Patients may optionally undergo biopsy during screening, on study, and at disease progression.
Biopsy
Undergo biopsy
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Ipilimumab
Given IV
Magnetic Resonance Imaging
Undergo MRI
Nivolumab
Given IV
Questionnaire Administration
Ancillary studies
Safety run-in & Arm B (nivolumab, ipilimumab, inulin gel)
Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning in cycle 5, patients receive nivolumab monotherapy IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inulin gel PO BID for 52 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving benefit from study treatment may optionally continue receiving inulin gel PO BID beyond 52 weeks at the discretion of the treating physician and in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and blood sample collection throughout the study. Patients may optionally undergo biopsy during screening, on study, and at disease progression.
Biopsy
Undergo biopsy
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Inulin
Given PO
Ipilimumab
Given IV
Magnetic Resonance Imaging
Undergo MRI
Nivolumab
Given IV
Questionnaire Administration
Ancillary studies
Interventions
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Biopsy
Undergo biopsy
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Inulin
Given PO
Ipilimumab
Given IV
Magnetic Resonance Imaging
Undergo MRI
Nivolumab
Given IV
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* Radiologic or clinical evidence of metastatic disease, or progressive locally advanced disease.
* 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 upper limit of normal (ULN) OR total bilirubin levels ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels \> 1.5 ULN.
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x ULN except for patients with liver metastases, AST/ALT should be ≤ 5 x ULN.
* Patient received no prior systemic anti-cancer therapy for metastatic disease.
* Patient has evaluable or measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Bone metastases, pleural effusion or ascites will be considered evaluable disease sites.
* Tumor mass: Must be accurately measurable in at least 1 dimension (longest diameter to be recorded) with a minimum size of:
* 10 mm by CT scan (CT scan slice thickness no greater than 5 mm,
Or:
* 20 mm by chest X-ray (if clearly defined and surrounded by aerated lung). With or without malignant lymph nodes: ≥ 15 mm in short axis when assessed by CT scan (CT scan slice thickness must be ≤ 5 mm). The measurement should be two dimensions at axial plane. The short axis should be in perpendicular to long diameter.
* Ability to understand and the willingness to review and sign a written informed consent.
* Both male and female patients must agree to use adequate contraceptive measures to prevent pregnancy throughout the duration of study therapy and a minimum of -5 months after stopping therapy per package insert of ipilimumab and nivolumab.
* Ability to ingest oral therapy.
* Female patient of childbearing capacity has a negative pregnancy test within 7 days of starting study therapy.
Exclusion Criteria
* 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.
* Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease must not require immediate CNS specific treatment at the time of study registration. Patients who have completed CNS therapy prior to starting therapy and clinically stabilized are also eligible.
* Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or make study participation not in the best interest of the patient, in the opinion of the treating investigator.
* Patient has known psychiatric or substance abuse disorders that, in the opinion of the investigator, would interfere with cooperation with the requirements of the trial.
* Pregnant patients or patients planning donation of sperm or breast milk during the therapy and for a minimum of 5 months after stopping therapy.
* Lactating patients if they do not agree to discontinue breast feeding through the entire duration of study participation and for 5 months after stopping therapy.
* History of another metastatic/relapsed active malignancy. Localized skin cancers such as basal cell or squamous cell cancer are allowed.
* Intractable nausea and vomiting refractory to therapy with antiemetics.
* History of hypersensitivity to ipilimumab, nivolumab, inulin or the formulations excipients.
* Known diagnosis of malabsorption disorder.
* Concurrent use of probiotics or antibiotics.
* Patients with a history of colectomy and/or gastric bypass.
* Patients with a known diagnosis of active inflammatory bowel disease or irritable bowel syndrome.
* History of organ transplant or stem cell/bone marrow transplant.
* Patients with active Clostridium difficile infection within 3 months before therapy start. Active infection is defined as a stool sample positive for Clostridium difficile toxin by enzyme immunoassay (EIA) and either symptoms (frequent loose stools) OR imaging findings consistent with toxic megacolon.
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ulka N Vaishampayan
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center
Locations
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University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2025-01192
Identifier Type: REGISTRY
Identifier Source: secondary_id
HUM00262019
Identifier Type: OTHER
Identifier Source: secondary_id
UMCC 2024.067
Identifier Type: OTHER
Identifier Source: secondary_id
HT94252310926
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UMCC 2024.067
Identifier Type: -
Identifier Source: org_study_id
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