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 aged 18 or older at the time of giving consent.
• People with advanced or metastatic kidney cancer (renal cell carcinoma) that includes a specific type called "clear cell."
• People who have previously been treated with a type of immunotherapy called an anti-PD-1 drug, and whose cancer got worse during or after that treatment. No other systemic cancer treatment is permitted after the anti-PD-1 therapy.
• People whose cancer can be measured on scans according to standard criteria (RECIST 1.1).
• People who are in generally good physical condition, rated 0 or 1 on a standard performance scale (meaning fully active or able to carry out light activity), assessed within 28 days before joining.
• People whose blood test results show the heart, liver, kidneys, and blood cells are functioning well enough, based on tests done within 2 weeks before joining (confirm specific thresholds with trial site).
• Women who could become pregnant must have a negative pregnancy test within 2 weeks before joining.
• Women who could become pregnant and men who could father a child must agree to use effective contraception or abstain from penile-vaginal intercourse during the trial.
• People living with HIV who are on effective treatment and have had an undetectable viral load within 6 months before joining.
• People with a known chronic hepatitis B infection must be on suppressive therapy with an undetectable viral load. People with a history of hepatitis C must have been successfully treated and cured, or if currently on hepatitis C treatment, must have an undetectable viral load.
• People who are able to understand and follow the study procedures for the full duration of the trial, as assessed by the enrolling doctor.

Who may not be able to join:

• People who have previously been treated with the study drug Zanzalintinib.
• People who have taken certain targeted cancer medicines called small molecule kinase inhibitors within 14 days before starting the study treatment.
• People who have received other systemic (whole-body) cancer treatments within 28 days before starting the study treatment, unless otherwise specified.
• People who have had radiation therapy to a bone within 2 weeks, or any other radiation therapy within 4 weeks, before starting study treatment. People who have received radioactive substance treatments within 6 weeks, or who have ongoing complications from prior radiation therapy.
• People with active brain metastases or cancer affecting the area around the brain and spine, unless the condition has been successfully treated and has been stable for at least 28 days. People must also not be experiencing neurological symptoms and must not be taking corticosteroid medicines at the time of starting treatment (confirm specific details with trial site).
• People who have used complementary medicines, herbal supplements, or traditional medicines to treat their cancer within 14 days before starting study treatment.
• People with an active infection that requires systemic treatment (people taking preventive antibiotics may still be eligible).
• People with an active tuberculosis (TB) infection requiring systemic treatment.
• People who are pregnant or breastfeeding.
• People with a history of severe allergic reactions to the study drugs or their ingredients.
• People with another current or previous cancer whose history or treatment could interfere with assessing the safety or effectiveness of this trial, as determined by the treating doctor.
• People who have received a live or weakened vaccine within 30 days before starting study treatment.
• People with a history of certain serious lung conditions, including idiopathic pulmonary fibrosis, organising pneumonia, drug-induced lung inflammation, or currently active lung inflammation.
• People who have previously had an organ transplant or stem cell transplant from a donor.
• People who are unable to swallow oral (tablet or capsule) medicines.
• People with uncontrolled major heart, lung, blood, or psychiatric conditions that would make participation unsafe.
• People with certain serious or uncontrolled heart conditions, including severe heart failure, unstable chest pain, serious heart rhythm problems, uncontrolled high blood pressure, a stroke or heart attack within the past 12 months, or a history of heart muscle inflammation.
• People who have had a serious blood clot in the lungs (pulmonary embolism) or a significant blood clot in a vein or artery within 6 months before starting treatment (some exceptions may apply — confirm with trial site).
• People with certain serious gut (gastrointestinal) conditions, including known varicose veins in the stomach or oesophagus, tumours growing into the gut, active stomach ulcers, inflammatory bowel disease, or recent gut perforation, fistula, or abscess within 6 months.
• People who have had significant bleeding — such as coughing or vomiting more than half a teaspoon of blood, or other serious bleeding — within 12 weeks before starting treatment.
• People with certain lung lesions or tumours growing into major blood vessels (confirm specific details with trial site).
• People with certain autoimmune diseases (some milder autoimmune conditions may still be eligible — confirm with trial site).
• People who require systemic steroids at doses above 10 mg prednisone per day (or equivalent) or other immune-suppressing medicines within 2 weeks of starting treatment (some exceptions apply — confirm with trial site).
• People with a condition that prevents proper absorption of medicines through the gut.
• People with serious non-healing wounds, ulcers, or bone fractures (some exceptions apply — confirm with trial site).
• People with uncontrolled, symptomatic underactive thyroid that has not been managed with medication.
• People with moderate to severe liver impairment (Child-Pugh B or C).
• People who require kidney dialysis.
• People who have had a life-threatening reaction to a prior immunotherapy drug, unless that reaction is unlikely to happen again and can be managed with standard care.
• People who have had major surgery within 8 weeks before starting treatment, or minor surgery within 10 days. All surgical wounds must be fully healed before starting treatment.
• People whose heart's electrical activity (measured by an ECG) shows a reading above a certain threshold within 14 days before starting treatment (confirm specific values with trial site).
• People with adrenal insufficiency (a condition where the adrenal glands do not produce enough hormones) that has not been adequately treated.

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