Phase 2 Kidney Cancer Trial, Recruiting

Written by an AI model from the 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 (RCC) with clear cell features, confirmed by a tissue sample (biopsy or surgical sample), with or without a more aggressive cell pattern called sarcomatoid features.
• People who have had at least one blood test using the Signatera® test (which looks for tiny traces of cancer DNA in the blood) within the past 90 days before joining the study.
• People who are 18 years of age or older at the time of signing the consent form.
• Women who could become pregnant must have a negative pregnancy test (urine or blood) within 72 hours before being assigned to a treatment group.
• Women who could become pregnant must be willing to use a reliable form of contraception during the study and for 120 days after the last dose of study treatment. Abstinence is acceptable if that is the person's usual practice.
• Men who could father a child must agree to use a reliable form of contraception from the first dose of study treatment through 120 days after the last dose. Abstinence is acceptable if that is the person's usual practice.
• People who provide written agreement (informed consent) to take part in the trial. Agreeing to an optional future research component is not required to join the main trial.
• People whose kidney cancer is classified as intermediate-high risk or high risk based on how far the tumour has spread and how abnormal the cancer cells look under a microscope (confirm specific staging details with trial site).
• People who have not received any prior treatment for advanced kidney cancer through the whole body (systemic therapy), except those who have only recently started a specific immunotherapy drug called pembrolizumab for no more than 6 weeks or one dose before joining.
• People who have had surgery to remove part or all of the affected kidney (partial or radical nephrectomy).
• People whose kidney surgery took place at least 28 days before signing the consent form and no more than 12 weeks before enrolling in the trial.
• People who are free of visible tumour at the time of joining, confirmed by a CT or MRI scan of the brain and chest/abdomen/pelvis taken within 28 days before being assigned to a treatment group.
• People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (ECOG performance status), meaning they are able to carry out at least some daily activities (confirm with trial site).
• People whose organs (such as kidneys, liver, and blood cells) are functioning well enough to meet the study's requirements (confirm specific values with trial site).

Who may not be able to join:

• People who have a condition that weakens the immune system, or who are currently taking high-dose steroid medicines or other immune-suppressing medicines within 7 days before the first dose of study treatment.
• People who have an active autoimmune disease (where the immune system attacks the body) that has needed medical treatment in the past 2 years. Routine hormone or gland replacement therapies are generally not considered a disqualifying treatment (confirm with trial site).
• People who have had another cancer within the past 3 years that is still growing or required active treatment, with some exceptions for certain early-stage or skin cancers treated with the intention to cure (confirm specific exceptions with trial site).
• People who have an active infection currently being treated with medicines given through the whole body (systemic therapy).
• People who are currently on dialysis or have a history of dialysis.
• People who have a known diagnosis of HIV (human immunodeficiency virus).
• People who have active hepatitis B or active hepatitis C infection.
• People who have a known history of active tuberculosis (TB).
• People who have a medical condition, past treatment, or abnormal test result that the treating doctor believes could affect the trial results or make participation unsafe.
• People who have a known psychiatric condition or substance use disorder that, in the doctor's opinion, would make it difficult to follow the requirements of the trial.
• People who have previously had a solid organ transplant (such as a kidney, liver, or heart transplant).
• People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.
• Women who could become pregnant and have a positive pregnancy test within 72 hours before being assigned to a treatment group.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period and up to 120 days after the last dose of study treatment.
• People who have previously received cancer treatment and have not yet recovered from the side effects of that treatment.
• People who have received a live vaccine (such as measles, mumps, rubella, chickenpox, yellow fever, or nasal flu spray) within 30 days before the first dose of study treatment. Standard injected flu vaccines are generally allowed.
• People who are currently taking part in, or have taken part in, another clinical trial using an experimental treatment or device within the 4 weeks before the first dose of study treatment.

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