Phase 2 Kidney Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are 18 years of age or older at the time of signing the consent form.
• People whose treating doctor considers them a suitable candidate for treatment with ipilimumab and nivolumab for kidney cancer that has spread to other parts of the body.
• People who are reasonably active and able to care for themselves, as measured by a standard health performance scale (a score of 2 or lower on the Zubrod scale).
• People who have been diagnosed with kidney cancer confirmed by a tissue or cell sample, specifically the clear cell or sarcomatoid type.
• People who have evidence, either from scans or clinical assessment, that their cancer has spread (metastatic) or is locally advanced and getting worse.
• People whose blood test results meet minimum levels for white blood cells, platelets, and haemoglobin (confirm with trial site for exact values).
• People whose kidney function and liver function blood tests fall within acceptable ranges as defined by the trial (confirm with trial site for exact values).
• People who have not previously received any systemic anti-cancer treatment for their metastatic disease.
• People who have at least one area of cancer that can be measured or assessed on scans according to standard criteria (RECIST 1.1), including bone spread, fluid around the lungs, or fluid in the abdomen.
• People who are willing and able to understand and sign a written consent form.
• People who are able to swallow and digest oral (tablet or liquid) medication.
• People who agree to use adequate contraception during the study treatment and for at least 5 months after finishing treatment.
• Women who could become pregnant must have a negative pregnancy test within 7 days of starting treatment.

Who may not be able to join:

• People who have received chemotherapy, biological cancer treatments, or immunosuppressant medications (not including steroids) within the past 4 weeks, or antibiotics within the past 2 weeks before starting the trial.
• People who are currently enrolled in another clinical trial or receiving another approved systemic treatment for kidney cancer at the same time.
• People who are taking steroid medication at a dose greater than 10 mg per day of prednisone (or equivalent), or any other immune-suppressing medication, within 7 days before the trial starts — except for people taking low replacement doses for adrenal insufficiency, which is permitted.
• People with an active and uncontrolled autoimmune disease — though some conditions such as type 1 diabetes, thyroid conditions managed with hormone replacement only, or certain skin conditions not requiring systemic treatment may still be eligible (confirm with trial site).
• People with brain metastases or disease affecting the lining of the brain or spinal cord that require immediate treatment at the time of joining — though people who have already completed treatment for brain metastases and are clinically stable may be eligible.
• People with any condition, treatment history, or abnormal test result that the treating doctor believes could interfere with the study results or make participation unsuitable.
• People with known psychiatric conditions or substance use disorders that the investigator believes would prevent them from meeting trial requirements.
• People who are pregnant, or who are planning to donate sperm or breastfeed during treatment and for at least 5 months after finishing treatment.
• People who are breastfeeding and do not agree to stop for the full duration of the study and for 5 months after finishing treatment.
• People with a history of another active cancer that has spread or returned — though localised skin cancers such as basal cell or squamous cell carcinoma are allowed.
• People with severe nausea and vomiting that cannot be controlled with anti-nausea medication.
• People with a known allergy or sensitivity to ipilimumab, nivolumab, inulin, or any ingredient in the study medications.
• People with a known diagnosis of a condition that affects how the body absorbs nutrients (malabsorption disorder).
• People currently using probiotics or antibiotics.
• People who have had their colon surgically removed (colectomy) or have had gastric bypass surgery.
• People with a known active diagnosis of inflammatory bowel disease or irritable bowel syndrome.
• People with a history of organ transplant or bone marrow/stem cell transplant.
• People who have had an active Clostridioides difficile (C. diff) bowel infection within the 3 months before starting the trial, confirmed by specific stool testing and accompanied by symptoms or scan findings.

Important: Always verify eligibility with the trial site directly before applying.