Phase 3 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 kidney cancer (renal cell carcinoma) that has spread to other parts of the body, confirmed by a tissue sample, and the cancer includes a specific type called "clear-cell."
• People whose kidney cancer is classified as "intermediate-risk" or "poor-risk" based on a standard scoring system called IMDC.
• Adults aged 18 or older.
• People who are reasonably able to carry out daily activities, as measured by a standard health performance scale (a score of 70% or higher on the Karnofsky scale).
• People whose blood counts and organ function meet specific minimum levels — including white blood cells, platelets, red blood cells, liver enzymes, and kidney function — as assessed by the treating doctor.
• People who are willing and able to follow all study visits and procedures as required by the trial.
• People who have read, understood, and signed the informed consent form before any trial procedures begin.
• People who are covered by a social security or health insurance system.
• Women who are not able to become pregnant, or women of childbearing potential who have a negative pregnancy blood test within 14 days before starting the study drug, and who agree to use one barrier method of contraception (such as a condom) plus one additional highly effective contraceptive method during treatment and for up to 5 months after the last dose.
• Men who could father a child and who agree to use a barrier method of contraception (such as a condom) during treatment and for up to 4 months after the last dose, and whose female partners of childbearing potential also agree to use a highly effective contraceptive method during the same period.
• Women of childbearing potential must not be pregnant at the time of screening.

Who may not be able to join:

• People who have previously received systemic cancer treatment for their metastatic kidney cancer, including experimental treatments. (Note: one prior course of adjuvant therapy after complete surgical removal of kidney cancer may be allowed, if the cancer returned at least 6 months after finishing that treatment — confirm with trial site.)
• People with brain metastases that are not well controlled. People whose brain metastases have been adequately treated with radiation may still be considered, but those with ongoing neurological symptoms from brain metastases, or who are taking more than 10 mg per day of prednisone (or equivalent steroid) at the time of joining, would not be eligible.
• People currently taking certain blood-thinning tablets (oral anti-vitamin K anticoagulants, such as warfarin). Some other types of blood thinners (injected or direct oral anticoagulants) may be permitted if the treating doctor considers it safe.
• People with serious uncontrolled health conditions, including:
  • Severe heart failure, unstable chest pain, recent heart attack, or dangerous heart rhythm problems.
  • High blood pressure that cannot be controlled with medication.
  • A stroke or serious blood clot event (such as a symptomatic pulmonary embolism) within the 3 months before joining the trial.
  • Active bleeding in the stomach or intestines, or a blockage in the digestive tract.
  • Significant uncontrolled bleeding, including from the urinary tract, vomiting of blood, or coughing up blood.
  • An autoimmune disease that has caused symptoms or required immune-suppressing treatment within the past two years. People with a history of Crohn's disease or ulcerative colitis are always excluded.
  • Any condition requiring ongoing steroid treatment above 10 mg per day of prednisone (or equivalent), or other immune-suppressing medications, within 14 days before joining. (Inhaled, nasal, joint-injected, or skin-applied steroids are generally permitted — confirm with trial site.)
  • An active infection currently requiring treatment with systemic medication.
  • Major surgery (such as kidney removal or brain surgery) within 4 weeks before joining, or a wound, ulcer, or bone fracture that has not properly healed.
• Women who are pregnant or breastfeeding.
• People who have another active cancer at the time of joining, or who have been diagnosed with another cancer within the past 3 years that required active treatment. (Some locally treated cancers that appear to be fully cured may still be eligible — confirm with trial site.)
• People who have a known allergy or sensitivity to any of the study drugs or their ingredients.
• People who have received a live vaccine within 28 days before joining the trial.
• People who are not free to make their own decisions, are under legal guardianship, or for whom completing the required medical follow-up would not be possible due to geographic, social, or psychological reasons.

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