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New treatment option for Locally Advanced Clear Cell Renal Cell Carcinoma
Official title Inulin Gel in Combination With Ipilimumab and Nivolumab for the Treatment of Metastatic or Locally Advanced Kidney Cell Cancer, ICON Trial
ClinicalTrials.gov ID: NCT06866262
What this study is testing
What is Ipilimumab?
Ipilimumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced clear cell renal cell carcinoma.
Also referred to as Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS 734016.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- Radiologic or clinical evidence of metastatic disease, or progressive locally advanced disease.
You likely can't join if
- The subject has received cytotoxic therapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) or...
- Patient is currently enrolled in another clinical trial testing another investigational agent, or concurrently in another approved systemic...
- Patient is on chronic systemic steroid therapy at doses \> 10 mg/day prednisone equivalent or on any other immunosuppressive therapy within 7 days...
- people with active and uncontrolled autoimmune disease. people with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis...
- Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease must not require immediate CNS specific...
- Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study...
See the full eligibility criteria
Who can join
- 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.
- 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...
- 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...
- Ability to ingest oral therapy.
- Female patient of childbearing capacity has a negative pregnancy test within 7 days of starting study therapy.
What rules you out
- 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...
- 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...
- people with active and uncontrolled autoimmune disease. people with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.