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 have signed a written consent form agreeing to take part in the trial.
• People who have been diagnosed with a type of kidney cancer called renal cell carcinoma (RCC) that includes clear cell features, confirmed by a pathology test.
• People who are willing and able to have a tissue sample (biopsy) taken from a tumour that will be treated with focused radiation — or who have had a biopsy taken before joining, provided that tissue is available for review at MD Anderson. People considered medically unfit for a biopsy, or for whom a biopsy would carry too much risk, may still be considered (confirm with trial site).
• People aged 18 or older at the time of signing the consent form.
• People with a general health and activity level rated as ECOG 0 or 1, meaning they are either fully active or have some limits on heavy physical activity but can still care for themselves. People who use a wheelchair due to paralysis may still meet this requirement (confirm with trial site).
• People who have at least one tumour that can be measured using standard imaging criteria (called RECIST 1.1).
• People with a limited number of cancer spread sites — five or fewer metastatic lesions at the time of joining. Cancer that has spread to the brain is allowed and counts toward this total. Very small lung spots and small lymph nodes may not be counted (confirm with trial site).
• People whose blood and organ function test results fall within the required ranges, with tests taken within 10 days before joining. This includes blood counts, kidney function, liver function, and blood clotting levels.
• People who have at least one tumour site that a radiation oncologist considers suitable for definitive radiation treatment and that can also be biopsied.
• People with a known history of Hepatitis B who have been on antiviral treatment for at least four weeks and have no detectable virus in their blood before starting the trial, and who are able to continue antiviral therapy during the trial.
• People with a history of Hepatitis C who have no detectable virus in their blood at screening and who completed curative antiviral treatment at least four weeks before joining.

Who may not be able to join:

• People whose last dose of immunotherapy (such as pembrolizumab, nivolumab, or ipilimumab) was taken less than 24 weeks before starting radiation, or whose last dose of other systemic (whole-body) cancer treatment was less than 4 weeks before starting radiation.
• People with a known HIV infection, a history of a primary immune system disorder, a history of receiving a transplanted organ or tissue from another person, or who have taken immune-suppressing medications within the 7 days before starting the trial (with some exceptions for low-dose or locally applied steroids).
• People with a psychiatric condition or substance use disorder that, in the opinion of the treating doctor or study team, would make it difficult to take part in the trial as required.
• People who have previously experienced severe (grade 3 or worse) immune-related side effects from checkpoint inhibitor treatments (such as PD-1, PD-L1, or CTLA-4 therapies), unless the side effect was a hormone-related issue that has been managed with hormone replacement.
• People who have received a live or live-attenuated vaccine within 30 days before starting the trial. Non-live (killed) vaccines are permitted.
• People who, in the opinion of the treating doctor or study team, have cognitive difficulties that would prevent them from giving proper informed consent or from taking part in required trial activities.
• People with widespread cancer that has spread in a way — such as to the lining of the brain and spine, throughout the bone marrow, or across the lining of the abdomen — that cannot be treated with definitive radiation, in the opinion of the treating doctor.
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial period. Women of childbearing potential must agree to use appropriate contraception during treatment and for at least 120 days after the last dose of study treatment.
• Women of childbearing potential who have a positive pregnancy test within 72 hours before joining the trial.

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