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 who have been diagnosed with kidney cancer (specifically, unresectable advanced or metastatic renal cell carcinoma with a clear cell component, or a type called translocation renal cell carcinoma) that cannot be removed by surgery, confirmed by laboratory testing of a tissue sample.
• People who have measurable areas of cancer that can be tracked using standard imaging criteria.
• People aged 18 years or older.
• People who are reasonably physically functional in daily life — the trial site will assess this using a standard medical scale (ECOG score of 2 or below, or Karnofsky score of 60% or above).
• People whose blood counts, liver function, and kidney function fall within acceptable ranges as determined by blood tests (confirm with trial site for specific values).
• People with low or no protein detected in their urine, or whose urine protein levels fall within acceptable limits on further testing.
• People who are able to swallow tablets or capsules.
• People who are willing and able to understand and sign a consent form agreeing to take part.
• People who are able to commit to using effective contraception (such as an intrauterine device, barrier methods, or abstinence) throughout the trial and for 90 days after finishing treatment; this applies to both women who could become pregnant and men.
• Women who could become pregnant must have a negative pregnancy blood test within 7 days before starting treatment.
• People who can provide a suitable tumour tissue sample — either a new biopsy taken during the screening period, or a preserved tissue block from within the past year where no cancer treatment was given between when the tissue was collected and joining the trial.

Who may not be able to join:

• People who have previously received systemic (whole-body) treatment for advanced or metastatic kidney cancer.
• People who received treatment before or after surgery for kidney cancer, where the cancer came back or got worse within 12 months of the last dose of that treatment.
• People who have previously received any immunotherapy treatment (such as checkpoint inhibitors, IL-2, or similar drugs targeting the immune system).
• People who have previously received axitinib or any other treatment targeting the VEGF pathway for metastatic kidney cancer, or any CDK4/6 inhibitor drug at any stage.
• People who have untreated brain metastases (cancer that has spread to the brain); people with treated and stable brain metastases may be considered if certain conditions are met (confirm with trial site).
• People who have had wide-field radiation therapy within the 2 weeks before starting treatment.
• People with an untreated blood clot in a vein (deep vein thrombosis) or lung (pulmonary embolism), or who had one of these events within 2 weeks before starting treatment.
• People who have had major surgery within the 4 weeks before joining the trial.
• People with serious or uncontrolled existing health conditions that, in the medical team's judgement, make participation unsafe — for example, severe lung disease, severe breathing difficulties, serious bowel conditions such as Crohn's disease or ulcerative colitis, or ongoing diarrhoea.
• People who have been taking immunosuppressive medications (drugs that lower the immune system's activity) within 7 days before joining, with some exceptions such as low-dose steroids, inhaled or topical steroids, or steroid pre-medications (confirm with trial site).
• People who have had a serious allergic reaction (Grade 3 or above) to monoclonal antibody drugs, or any history of anaphylaxis (severe allergic shock).
• People with an active autoimmune disease that could worsen when the immune system is stimulated; some conditions such as Type 1 diabetes, vitiligo, psoriasis, or thyroid conditions not requiring immune-suppressing treatment may still be eligible (confirm with trial site).
• People who have received a live vaccine within 4 weeks before starting treatment or during the trial (inactivated vaccines, including COVID-19 vaccines, are generally permitted — confirm with trial site).
• People who have had a significant bleeding event (Grade 3 or above) within 4 weeks before joining.
• People with an active serious infection requiring intravenous antibiotics, or a known active fungal or viral infection, including HIV.
• People with known Hepatitis B or Hepatitis C infection where there is evidence of active infection on testing.
• People who have previously had a stem cell transplant or a solid organ transplant (such as a kidney or liver transplant).
• People with conditions affecting the stomach or bowel that significantly interfere with absorbing oral medications (such as severe nausea, vomiting, diarrhoea, or previous small bowel removal).
• People currently taking warfarin or related blood-thinning medications (certain other blood thinners such as low molecular weight heparin or apixaban may be permitted — confirm with trial site).
• People diagnosed with another cancer within the past 2 years, unless the treating doctor considers it to carry a very low risk of spreading or affecting life expectancy (some low-risk skin or in-situ cancers may be exceptions — confirm with trial site).
• People with a personal history of fainting due to a heart cause, dangerous heart rhythm problems, inflammation of the heart muscle (myocarditis), or sudden cardiac arrest.
• People who have had a major heart or blood vessel event within the past 6 months — such as a heart attack, stroke, unstable chest pain, or severe heart failure.
• People with an ongoing significant abnormal heart rhythm, a history of long QT syndrome, or any history of myocarditis.
• People with a history of interstitial lung disease, other restrictive lung conditions, previous radiation to the chest, or any history of lung inflammation (pneumonitis).
• People with a significant smoking history of more than 30 pack-years (calculated as packs smoked per day multiplied by years smoked).
• People with a known allergy to any of the study drugs or their ingredients.
• People currently taking, or expected to need, certain medications that strongly affect how the study drugs are processed by the body (known as strong CYP3A4/5 inhibitors or inducers); this includes some antifungal, antibiotic, antiviral, and anticonvulsant drugs, as well as grapefruit and related citrus fruits (confirm the full list with the trial site).
• People who have taken herbal supplements within 7 days before starting treatment, including but not limited to St. John's Wort, ginkgo biloba, ginseng, or similar products.
• People who are currently pregnant or breastfeeding.
• People whom the trial medical team considers unsuitable to participate, or who are unlikely to be able to follow the trial's procedures and requirements.

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