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 are willing to take part and sign a written consent form
• People aged 18 or older
• People whose general health and ability to carry out daily activities meets a certain minimum level, as measured by a standard medical scale (confirm with trial site)
• People who have kidney cancer (renal cell carcinoma) larger than 4.0 cm, confirmed by biopsy, with no spread into nearby large blood vessels — classified as a certain early-to-intermediate stage (T1b or T2)
• People who are not suitable for standard kidney removal surgery, or who have chosen not to have it
• People whose liver is functioning well enough, based on specific blood test results (confirm with trial site)
• People whose blood counts meet minimum levels for red blood cells, white blood cells, and platelets, based on blood tests (confirm with trial site)
• Women who could become pregnant must have a negative pregnancy test within 48 hours before starting treatment, and must agree to use a barrier method plus a second highly effective form of contraception during treatment and for 7 months after the last dose — or practice complete abstinence if that fits their usual lifestyle
• Men who are sexually active must use a condom during intercourse throughout treatment and for at least 120 days after the last dose, and must not father a child during this time
• Male participants whose partners could become pregnant must also use a second highly effective form of contraception during treatment and for at least 4 months after the last dose — or practice complete abstinence if that fits their usual lifestyle
• Men who have had a vasectomy are still required to use a condom during intercourse, including with a male partner, to prevent the study drug from being passed through semen

Who may not be able to join:

• People whose cancer has spread to other parts of the body, as shown on a CT or MRI scan
• People with severely reduced kidney function (below a certain threshold) who are not on dialysis
• People with kidney cancer in both kidneys, where there is no plan to treat the other kidney's tumour
• People whose kidney cancer has come back at the same site where a previous surgery or ablation was done (a new tumour in the same or opposite kidney is allowed)
• People who have previously had radiation therapy to a kidney, or who have received or are currently receiving certain systemic drug treatments for kidney cancer (immunotherapy or targeted therapy)
• People where pre-procedure imaging shows too much radiation would reach the lungs during the treatment (above certain dose limits)
• People where pre-procedure imaging shows the study treatment would not be able to reach all parts of the tumour adequately, in the treating doctor's judgement
• People for whom the procedure to examine blood vessels in the kidney, or the use of contrast dye for both CT and MRI, is medically unsafe
• People with a history of severe allergic reaction to CT contrast dye or to any ingredient in the study treatment that cannot be managed with medication
• People with a history of chronic lung disease where their blood oxygen level at rest falls below 90%, or who need oxygen at home
• People with heart failure where the heart's pumping strength falls below a certain level
• People with an active infection that the treating doctor considers clinically significant
• People with any severe or unstable long-term health condition that, in the treating doctor's opinion, would put them at unacceptable risk — including but not limited to unstable chest pain, certain heart conditions, certain lung conditions, or severe bowel disease with diarrhoea
• People with a life expectancy of one year or less (confirm with trial site)
• People who are pregnant or breastfeeding

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