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 (renal cell carcinoma) confirmed by a tissue or cell sample before joining the trial
• People whose kidney cancer has spread to nearby lymph nodes and cannot be surgically removed, or has spread to other parts of the body (metastatic)
• People who have had a physical examination and CT or MRI scan of the chest, abdomen, and pelvis within the past 45 days
• People whose kidney cancer is classified as "intermediate risk" (1–2 risk factors) or "poor risk" (3 or more risk factors) according to a standard medical scoring system called IMDC
• People who have, or have had, another cancer that is unlikely to interfere with this trial's treatments or assessments
• People who have measurable areas of cancer spread (outside the main kidney tumour) that can be tracked on scans using standard measurement guidelines
• People who have not been recommended for, or have declined, immediate surgery to remove the kidney tumour
• People who are considered suitable for standard treatment combinations involving immunotherapy drugs
• People whose main kidney tumour measures 20 cm or less in one specific direction on a scan
• People aged 18 or older
• People with a reasonable level of physical functioning, as measured by a standard scale (Karnofsky score of 60 or above), assessed within the past 45 days
• People with blood test results within acceptable ranges within the past 45 days, including: haemoglobin of at least 8 g/dL (blood transfusions are permitted), platelet count of at least 50,000/mm³, neutrophil count of at least 1,500/mm³, and kidney function showing a clearance rate of at least 30 mL/min
• People with liver function blood test results within acceptable ranges within the past 45 days
• People living with HIV who are on effective treatment and have had an undetectable level of the virus within the past 6 months
• People with chronic hepatitis B who are on treatment and have an undetectable viral load
• People who previously had hepatitis C and have been successfully treated and cured, or who are currently being treated for hepatitis C with an undetectable viral load
• People who agree to use highly effective contraception during the trial and for 6 months after the last dose of the study treatment (this includes men who have had a vasectomy if their partner could become pregnant)
• People who are willing and able to provide signed informed consent before joining the trial

Who may not be able to join:

• People for whom doctors plan to treat all areas of cancer spread using surgery, high-dose radiation, or other definitive procedures in a way that would leave no measurable disease outside the kidney
• People who have brain or spinal fluid (epidural) involvement from their cancer that has not been treated or is not stable — though people whose brain metastases have been treated (with radiation, radiosurgery, or surgery) and have been stable for at least 4 weeks, with no need for steroids and no signs of worsening, may still be considered eligible (confirm with trial site)
• People who have previously had radiation therapy to the kidney in a location that would overlap with where radiation would need to be given in this trial
• People who started any systemic (whole-body) treatment for metastatic kidney cancer more than 90 days before joining the trial (prior chemotherapy for a different cancer that was completed more than 3 years ago is allowed)
• People with an active autoimmune disease that requires ongoing treatment with corticosteroids above a certain dose or other immune-suppressing medications
• People who have had a severe allergic or hypersensitivity reaction to certain types of antibody-based medications
• People with active tuberculosis
• People with blood pressure that is not controlled (systolic 190 mmHg or above, or diastolic above 110 mmHg)
• People who have had major surgery requiring a hospital stay within the past 28 days
• People with a serious non-healing wound, ulcer, or bone fracture within the past 45 days
• People who have had a serious arterial blood clot event such as a heart attack or stroke within the past 180 days
• People with serious active heart failure symptoms (classified as New York Heart Association class 3 or 4)
• People with moderate or severe liver disease
• People who have had an untreated blood clot in the lung or leg veins within the past 180 days (treated or symptom-free clots more than 30 days before joining may be acceptable — confirm with trial site)
• People with an unstable heart rhythm disorder within the past 180 days
• People with a history of certain serious abdominal problems — such as a hole in the bowel, a fistula, a bowel blockage, or an internal abdominal infection — within the past 180 days
• People with a history of, or currently active, inflammatory bowel disease
• People with a condition that prevents normal absorption of food and nutrients, within the past 45 days
• People who are pregnant or unwilling to stop breastfeeding — women who could become pregnant must have a negative pregnancy test within 45 days before joining

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