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 specific type of kidney cancer (called clear cell renal cell carcinoma, with or without certain aggressive features) that has been confirmed by laboratory testing of removed tissue.
• People who have had surgery to remove all or part of the affected kidney (full or partial removal), even if the surgeon found very small amounts of cancer at the edges of the removed tissue under a microscope, as long as no obvious remaining cancer was visible.
• People whose cancer is classified as intermediate-high risk, meaning the tumour had certain aggressive features or had grown into surrounding tissue, but had not spread to lymph nodes or other organs.
• People whose cancer is classified as high risk, meaning the tumour had grown extensively into nearby tissue and/or had spread to nearby lymph nodes, but not to distant organs.
• People who had cancer that had spread to one isolated area outside the kidney (but not to the brain or bones) and had that spread treated — either at the time of kidney surgery or within one year after — through surgery, radiation, or ablation, with no remaining detectable cancer at the time of joining the trial.
• People whose surgery was completed more than 4 weeks but no more than 16 weeks before joining the trial, with no ongoing surgical complications.
• People aged 18 or older.
• People who are generally well enough to carry out basic daily activities (confirm with trial site for exact fitness level required).
• People whose blood counts, liver function, and kidney function meet certain minimum levels as measured by blood tests (confirm with trial site for exact values).
• People whose urine protein levels are within an acceptable range as measured by urine testing.
• Women who could become pregnant must have a negative pregnancy test within 14 days before joining the trial.
• People living with HIV who are on effective HIV treatment and have had an undetectable level of virus in their blood within the past 6 months.
• People with a history of hepatitis B who are on suppressive treatment and have an undetectable viral load, or who have cleared the infection (confirm with trial site).
• People with a history of hepatitis C who have been fully treated and cured, or who are currently on treatment with an undetectable viral load.
• People with a history of heart disease, provided their heart function is assessed as class IIB or better using a standard medical classification system (confirm with trial site).
• People who have had a previous or current separate cancer, as long as that cancer or its treatment is not expected to interfere with this trial's safety or results.
• People with certain stable or mild conditions such as vitiligo, psoriasis, type 1 diabetes, hypothyroidism, or resolved childhood asthma, or those using inhaled medications, local steroid injections, or hormone replacement therapy.

Who may not be able to join:

• People who have received any prior systemic (whole-body) treatment for kidney cancer.
• People who are currently pregnant or breastfeeding, as the study drug is known to be harmful to a developing baby.
• People with a history of inflammation of the heart muscle (myocarditis).
• People with a history of significant inflammation of the lungs (pneumonitis).
• People with uncontrolled high blood pressure, confirmed on two separate measurements taken at least two hours apart.
• People with a wound, ulcer, or bone fracture that has not healed, within 28 days before joining the trial.
• People with a serious active infection currently requiring intravenous antibiotics.
• People with moderate or severe liver disease (as classified by a specific medical scoring system).
• People who have had significant bleeding events within one month before joining the trial, such as serious bleeding from the stomach or bowel, lungs, or urinary tract.
• People who have previously received an organ transplant from another person.
• People with a known allergy or serious reaction to the study drugs or their ingredients.
• People who need ongoing treatment with corticosteroid tablets or other immune-suppressing medications above certain doses, within a defined period before starting the trial (confirm with trial site for exact timeframes and dose thresholds). Low-dose or inhaled/topical steroids may be allowed.
• People with active stomach ulcers, inflammatory bowel disease, ulcerative colitis, or other bowel conditions that increase the risk of a bowel perforation; or people who have had a bowel perforation, abdominal fistula, or abscess within 4 weeks before joining the trial.
• People who have had an autoimmune disease requiring ongoing systemic treatment within the past 2 years (with some exceptions, such as those on hormone replacement or short-term steroid use considered standard care).
• People who are taking strong medications that significantly affect how the body processes certain drugs (called strong CYP3A4 inducers), unless they have stopped taking them at least 14 days before starting the trial treatment.

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