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:

• People who have been diagnosed with a hereditary condition called HLRCC and have a confirmed kidney cancer consistent with that diagnosis (Cohort 1), OR people with confirmed non-hereditary papillary kidney cancer (Cohort 2)
• People whose kidney cancer has advanced or spread, and who have at least one tumour that can be measured by X-ray, CT scan, MRI, or physical exam at a specific minimum size
• People who have received no more than two prior treatments targeting a cancer-growth pathway called VEGF, have never received bevacizumab, and have never received PD-1 or PD-L1 immunotherapy for advanced or metastatic kidney cancer (no prior treatment is required to be eligible)
• People aged 12 years or older
• People who are well enough to carry out some daily activities, rated as ECOG performance status 2 or better (Karnofsky score of 60% or higher)
• People whose blood counts meet minimum thresholds: neutrophils at or above 1,000 per microlitre and platelets at or above 100,000 per microlitre
• People whose liver function test results fall within acceptable ranges as determined by the trial site
• People whose kidneys are functioning at an acceptable level, as measured by a filtration rate of at least 30 mL/min/1.73m² (with different creatinine thresholds applying for those under 18, confirm with trial site)
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months
• People with chronic hepatitis B who are on suppressive therapy and have an undetectable viral load
• People who have been treated and cured of hepatitis C, or who are currently being treated for hepatitis C with an undetectable viral load
• People who have had brain metastases that were treated, provided that follow-up brain scans show no sign of the cancer returning or growing for at least 3 months, and who no longer need more than a low maintenance dose of steroids
• People who have had another cancer previously or at the same time, provided the trial site determines that the other cancer is unlikely to interfere with the safety or results of this trial
• People with a known heart condition history who have been assessed using a standard heart function scale and rated as Class 2B or better
• People of childbearing potential (both women and men) who agree to use adequate contraception before, during, and for 6 months after completing the study treatment
• People who are able to provide tumour tissue samples (either from stored samples or through a new biopsy) for review
• People who are able to understand and sign an informed consent form, or who have a legally authorised representative to do so on their behalf

Who may not be able to join:

• People who have received systemic kidney cancer treatment within 4 weeks (or within 5 half-lives of the drug, whichever is shorter) before the trial start date
• People who have had radiotherapy for kidney cancer within 2 weeks before the trial start date
• People who have had a major surgical procedure within 28 days before the trial start date, or whose surgical wounds have not yet fully healed
• People who are still experiencing significant side effects from previous cancer treatments that have not resolved to a mild level (with exceptions for hair loss and certain correctable mineral imbalances)
• People who have taken part in another clinical trial involving an experimental treatment within 4 weeks before the trial start date
• People who have received certain immune-stimulating medications (such as interferon or interleukin-2) within 6 weeks before the trial start date
• People who have taken immune-suppressing medications (such as prednisone, methotrexate, or similar drugs) within 2 weeks before the trial start date, with some exceptions for low-dose or inhaled medications as determined by the trial site
• People with high blood calcium levels that have not been corrected before starting treatment
• People taking bisphosphonate drugs specifically to treat high blood calcium levels (use for other reasons such as bone metastases or osteoporosis is permitted)
• People with a history of autoimmune diseases (such as lupus, rheumatoid arthritis, multiple sclerosis, or similar conditions), with some specific exceptions for well-controlled conditions such as autoimmune thyroid disease on stable treatment, type 1 diabetes on stable insulin, and certain mild skin conditions meeting specific criteria (confirm with trial site)
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, drug-induced lung inflammation, or currently active lung inflammation
• People with untreated latent or active tuberculosis
• People who have had a serious infection requiring hospitalisation within 4 weeks before the trial start date
• People who have received a live vaccine within 4 weeks before the trial start date, or who would need a live vaccine during the study or within 5 months after the last dose of one of the study drugs (note: standard injected flu vaccines are generally allowed; nasal spray flu vaccines are not)
• People with serious uncontrolled health conditions such as active infections requiring intravenous antibiotics, heart failure, unstable chest pain, irregular heartbeat, or mental health or social circumstances that would make it difficult to follow the study requirements
• People with poorly controlled high blood pressure despite appropriate medical management, or a history of hypertensive crisis or hypertensive brain swelling
• People who have previously had a bone marrow transplant from a donor or a solid organ transplant
• People who have had a severe allergic reaction to medicines chemically similar to the study drugs
• People who have had a heart attack, a hole or tear in the digestive tract, an abdominal abscess, or a stroke within 6 months before the trial start date
• People with high levels of protein in their urine above a specified threshold, confirmed by a 24-hour urine collection test
• Women who are pregnant, as the study drugs may harm an unborn baby
• Women who are breastfeeding, as the potential risk to a nursing infant is unknown
• People with a serious wound, ulcer, or bone fracture that has not healed within 3 months before starting treatment
• People who are taking certain medications or herbal supplements known to strongly affect the way the body processes the study drugs (confirm specific medications with the trial site)
• People who currently use tobacco or nicotine products and are unable to stop for the full duration of the study treatment
• People with significant blood vessel disease (such as a large aortic aneurysm or recent arterial blood clot) within 6 months before the trial start date
• People who have coughed up blood within 1 month before the trial start date
• People with a history of a severe blood clot in a vein (grade 4 or higher)
• People with a known inherited bleeding disorder or significant clotting problem
• People currently using high-dose aspirin (more than 325 mg per day) or clopidogrel (more than 75 mg per day) within 10 days before starting the study treatment

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