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 signed a consent form before any study procedures begin
• People who are willing and able to follow the study's procedures and requirements
• People aged 18 or older
• People who have been diagnosed with metastatic renal cell carcinoma (a type of kidney cancer that has spread), confirmed by a core needle biopsy — all subtypes are accepted
• People whose kidney cancer has spread to other parts of the body at the same time the original tumour is still present in the kidney
• People who have measurable tumour(s) that can be tracked on scans, according to a standard measurement system (RECIST v1.1)
• People for whom a doctor considers a specific combination immunotherapy treatment (nivolumab/ipilimumab or a similar TKI/IO combination) to be appropriate, in line with European and national health authority recommendations
• Women who are not pregnant (confirmed by a blood test) and not breastfeeding, or who cannot become pregnant due to menopause, removal of the uterus, or removal of the ovaries
• Women who could become pregnant, and men who are fertile, must be using an effective form of contraception
• People with a general health and activity level rated at 70 or above on the Karnofsky Performance Scale (a medical measure of how well someone is functioning day-to-day) (confirm with trial site)
• People with a life expectancy of more than 4 months
• People whose blood test results show adequate bone marrow, liver, and kidney function, and normal blood clotting levels, within ranges specified by the trial

Who may not be able to join:

• People who have already received systemic (whole-body) treatment for their metastatic kidney cancer
• People who have had another cancer within the past 3 years (exceptions may apply for certain very early-stage skin cancers or localised prostate cancer with undetectable levels on a PSA blood test)
• People who have had a major surgery, open surgical biopsy, or significant injury within the 28 days before enrolling
• People with significant active heart or blood vessel problems, such as a stroke or heart attack within the past 6 months, unstable chest pain, or moderate-to-severe heart failure
• People with brain metastases (cancer that has spread to the brain) that are causing symptoms and require high-dose steroid medication
• People who have taken part in another clinical trial or received an experimental treatment within the 30 days before joining
• People with an active or recent autoimmune disease (where the immune system attacks the body), or conditions currently requiring high-dose steroid or immune-suppressing medication — though some exceptions apply, such as vitiligo, type 1 diabetes, thyroid conditions managed with hormone replacement, or mild psoriasis not needing systemic treatment
• People with a known allergy or sensitivity to monoclonal antibody medicines
• People known to have HIV or AIDS
• People with an active or chronic hepatitis B or C infection, shown by a positive test
• People who have taken oral or intravenous (IV) antibiotics within the 14 days before starting treatment in the study

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