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:

• Adults aged 18 or older at the time of giving consent.
• People who have signed a written consent form and agreed to the release of personal health information before joining the trial.
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard health scale (ECOG score of 0 or 1), assessed within 30 days before joining.
• People who have been confirmed through a tissue sample to have a specific type of kidney cancer called clear cell renal cell carcinoma, with or without certain aggressive features (sarcomatoid); the tissue biopsy must be done at least 5 days before starting treatment and must be fully healed before the first dose.
• People whose kidney cancer is locally advanced (classified as stage cT3/T4, with or without nearby lymph node involvement), or whose cancer has been assessed by a surgeon as difficult or not possible to operate on at this time — either criterion alone is enough to qualify.
• People who have very small areas of cancer spread to soft tissue (less than 10mm) or slightly enlarged lymph nodes (less than 15mm in a specific measurement), as these small findings are allowed.
• People whose side effects from any past treatments have returned to near-normal or mild levels, or whose ongoing mild side effects are considered stable and manageable.
• People whose blood and organ function results from tests done within 30 days before starting treatment meet all the required levels for blood counts, kidney function, liver function, and urine protein (confirm specific values with the trial site).
• Women who could become pregnant must have a negative pregnancy test within 48 hours before starting treatment.
• Women who could become pregnant and are sexually active with a male partner who could father a child must be willing to either avoid that sexual activity or use effective contraception; male participants who could father a child and are sexually active with a woman who could become pregnant must do the same.
• People who, in the opinion of the enrolling doctor, are able to understand and follow the study procedures for the full duration of the trial.

Who may not be able to join:

• People whose kidney cancer is not the clear cell type.
• People who have measurable cancer that has spread to other parts of the body, or who have certain other spread such as bone metastases, cancer in the lining of the brain, cancer in the lymph vessels of the lungs or skin, or confirmed cancerous fluid build-up around organs.
• People who have previously received systemic treatment for kidney cancer, including the specific drugs used in this trial (zanzalintinib, nivolumab) or similar types of targeted or immunotherapy drugs.
• People who have had surgery or radiation therapy directly to the kidney tumour being studied in this trial (prior treatment to a different area of the kidney more than 4 weeks before the first dose may be allowed).
• People currently taking certain blood-thinning or clot-preventing medications such as warfarin, direct thrombin inhibitors, or clopidogrel, unless these have been stopped for the required period before starting treatment; some other blood thinners may be allowed under specific conditions (confirm with trial site).
• People who have taken herbal supplements or traditional medicines to treat their cancer within 2 weeks before starting treatment.
• People with serious uncontrolled heart conditions, including severe heart failure, unstable chest pain, dangerous heart rhythm problems, uncontrolled high blood pressure despite medication, a recent stroke or heart attack within 6 months, a significant blood clot event within 3 months, or a history of heart muscle inflammation (myocarditis).
• People with serious stomach or bowel conditions, including active ulcers, inflammatory bowel disease, bowel blockage, holes or openings in the bowel, abdominal abscesses, or known abnormal blood vessels in the stomach or oesophagus.
• People who have had significant bleeding (more than half a teaspoon of red blood) from any source within 12 weeks before starting treatment.
• People with symptomatic lung lesions of a specific type (cavitating) or cancer blocking the airways, unless asymptomatic or already treated with radiation.
• People whose cancer is growing into a major blood vessel (note: cancer extending into the kidney vein or the large vein leading to the heart is still allowed).
• People with an active infection that requires treatment with medications taken throughout the body.
• People with a known active or chronic hepatitis B or C infection.
• People with HIV or AIDS-related illness, unless they meet specific criteria related to stable treatment, immune cell counts, and undetectable virus levels (confirm with trial site).
• People with a serious wound, ulcer, or bone fracture that has not healed.
• People with a condition that prevents proper absorption of nutrients from food.
• People with underactive thyroid that is not controlled with medication and is causing symptoms.
• People with moderate to severe liver disease (Child-Pugh class B or C).
• People who require kidney dialysis (hemodialysis or peritoneal dialysis).
• People who have had a solid organ transplant or a stem cell transplant from a donor.
• People who have had major surgery within 8 weeks before starting treatment, certain keyhole surgeries within 4 weeks, or minor surgery within 5 days; all surgical wounds must be fully healed before starting treatment.
• People whose heart's electrical activity (specifically the QTc interval) is above a set level on a heart tracing (ECG) done within 14 days before starting treatment (confirm specific value with trial site).
• People with a history of a psychiatric condition that is likely to make it difficult to follow the study requirements or give informed consent.
• People who are pregnant or breastfeeding.
• People who are unable to swallow tablets or take a liquid form through the mouth or a feeding tube.
• People who have a known allergy or sensitivity to any ingredient in the study medications.
• People who have another cancer that is currently being treated and that could, in the doctor's opinion, interfere with assessing how the kidney cancer responds to treatment, within the past 2 years (some low-risk skin cancers and certain early-stage prostate cancers may still be allowed).
• People with any other condition that, in the doctor's opinion, would put them at risk or prevent them from completing the study.
• People with an active, known, or suspected autoimmune disease (some mild autoimmune-related conditions may still be allowed — confirm with trial site).
• People with a confirmed positive tuberculosis test supported by signs of active disease on imaging or examination.
• People with a history of certain types of lung scarring or inflammation, or with signs of active lung inflammation on a recent CT scan.
• People with thyroid hormone (free T4) levels outside the normal range, unless they have no symptoms and are approved by the lead investigator.
• People with a diagnosed immune deficiency, or who are taking high-dose steroid tablets or other immune-suppressing medications within 2 weeks before starting treatment (some exceptions apply — confirm with trial site).
• People who have received a live vaccine within 30 days before starting treatment.

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