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 are 18 years of age or older at the time of joining the study.
• People who have been diagnosed with a type of kidney cancer called renal cell carcinoma (RCC) with a specific cell type called "clear cell," confirmed through a tissue sample test.
• People whose cancer has spread to nearby areas and cannot be surgically removed, or has spread to other parts of the body.
• People whose cancer can be measured on scans, as assessed by the study investigator using a standard method called RECIST version 1.1.
• People who have not previously received a specific type of cancer drug called a VEGF tyrosine kinase inhibitor; up to one prior treatment with a cytokine or immune checkpoint therapy is allowed, provided scans show the disease got worse during or after that treatment.
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work).
• People whose blood tests show their organs (such as kidneys and liver) and blood cell counts are working at an adequate level.
• People who are at least 2 weeks past their last cancer treatment or radiation therapy before being assigned to the trial.

Who may not be able to join:

• People who still have significant ongoing side effects (rated Grade 2 or higher) from a previous cancer treatment, with some exceptions for hair loss or certain mild lab abnormalities that are not causing symptoms.
• People who have cancer that has spread to the brain or spinal cord and has not yet been treated; people with treated brain metastases may still be considered if scans taken at least 4 weeks after treatment show no new or worsening spread.
• People who have had another type of cancer requiring treatment within the past 3 years; exceptions may apply for certain less serious skin cancers, early-stage cancers confined to one area, or a specific non-invasive form of bladder cancer.
• People with poorly controlled high blood pressure (systolic at or above 160 mmHg or diastolic at or above 100 mmHg); re-screening after blood pressure medication adjustments may be permitted.
• People who have been diagnosed with a blood clot in the lungs or a deep vein within the 3 months before joining the trial.
• People with a specific irregularity in their heart's electrical activity, measured as a QTcF interval greater than 480 milliseconds on a heart tracing (ECG).
• People with a serious heart condition classified as New York Heart Association Class III or IV heart failure.
• People who have taken certain medications that are not permitted within 7 days or 5 half-lives (whichever is shorter) before the first dose of the study drug (confirm with trial site for the specific list of prohibited medications).

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