Phase 3 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 have been diagnosed with a type of kidney cancer called renal cell carcinoma (with a clear cell component) that has spread or cannot be removed or cured with surgery or radiation
• People who have areas of cancer that can be measured or assessed on scans, including those whose cancer has spread only to bones or who have fluid around the lungs
• People who have cancer that has spread to the brain or the lining around the brain, as long as that does not require immediate treatment at the time of joining or during the first round of therapy
• People who are at least 18 years old at the time of joining the trial
• People who have a general health status rated between 0 and 2 on a standard medical scale (meaning they are fully active to capable of limited self-care), assessed within 28 days before joining (confirm with trial site)
• People whose doctors determine they are medically suitable to receive at least one of the standard approved treatment combinations for this type of kidney cancer
• People who are able to swallow and keep down oral (by mouth) medications, with no known digestive conditions that would prevent this
• People whose recent blood test results (taken within 28 days before joining) show kidney function, blood counts, and liver function within the levels required by the trial
• People living with HIV who are on effective treatment and have had an undetectable viral level on their most recent test within the past 6 months
• People with a history of chronic hepatitis B who are on suppressive therapy and have had an undetectable viral level on their most recent test within the past 6 months
• People with a history of hepatitis C who have been treated and cured, or who are currently being treated and have an undetectable viral level on their most recent test within the past 6 months
• People who have blood pressure that is under control within 28 days before joining
• People who are not pregnant or breastfeeding, and people of reproductive potential who have agreed to use effective contraception as outlined in the consent process
• People who have signed an informed consent form agreeing to take part, understanding the investigational nature of the study (or whose legal representative has done so on their behalf)

Who may not be able to join:

• People who are currently enrolled in another treatment study or plan to join one while on this trial
• People who plan to take over-the-counter probiotic supplements at the time of joining or during treatment (note: vitamin, electrolyte, and mineral supplements are permitted)
• People who have previously received systemic (whole-body) treatment for advanced or metastatic kidney cancer, or any immune-based combination therapy — although prior treatment with certain immunotherapy drugs for any cancer may be acceptable if it was completed more than 12 months before joining (confirm with trial site)
• People who are taking steroid replacement therapy for a condition called adrenal insufficiency at a dose higher than the equivalent of 50 mg of hydrocortisone per day
• People who require ongoing steroid medication (such as prednisone) at more than 10 mg per day for any reason other than adrenal insufficiency replacement
• People who have taken any antibiotic medicines in the 7 days before joining (and people with active uncontrolled infections must have fully recovered before joining)
• People with another cancer (current or past) that their doctor believes could interfere with assessing the safety or effectiveness of the trial treatments
• People with a known history of an autoimmune disease that would prevent the use of immune checkpoint therapy
• People whose kidney cancer is classified as "favorable risk" by a standard medical scoring system (called IMDC) are not eligible to receive the ipilimumab and nivolumab combination in this trial, though they may be eligible for other treatment combinations (confirm with trial site)

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