Phase 3 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:

• You have been diagnosed with muscle-invasive bladder cancer or cancer of the urethra, ureter, or renal pelvis, confirmed by a tissue biopsy
• Your cancer is mainly urothelial (bladder-type) cancer, even if it has some other features mixed in (confirm with trial site for specific subtypes)
• You have had major surgery to remove your bladder, kidney, or ureter at least 3 weeks ago but no more than 12–16 weeks ago (the exact window depends on which testing pathway applies to you)
• Your surgery removed the cancer with no visible cancer left behind at the edges of the removed tissue (small amounts of cancer cells at the margins may still be acceptable — confirm with trial site)
• There is no sign of remaining cancer or spread to other parts of the body after your surgery
• Your cancer was found to be at high risk of coming back, based on how far it had spread at the time of surgery
• You are 18 years of age or older
• You are well enough to carry out some daily activities (your doctor will assess this using a standard scale)
• You are not pregnant and not breastfeeding
• You have had a specific blood test called a Signatera test (which looks for traces of cancer DNA in the blood), either through a commercial lab or through the study's own testing process
• Your blood counts and organ function (kidneys, liver) meet certain minimum levels based on recent blood tests
• If you have HIV, you are on effective treatment and your virus levels are undetectable
• If you have or had hepatitis B or C, your virus levels are undetectable or you have been successfully treated
• You have certain autoimmune conditions that are mild and well-controlled (such as vitiligo, thyroid conditions managed with hormones, or type 1 diabetes) — confirm with trial site
• You have rheumatoid arthritis, Sjögren's syndrome, or psoriasis controlled with creams or topical treatments — confirm with trial site

Who may not be able to join:

• You had only a partial bladder removal as your main surgery (rather than full removal)
• You have signs of cancer spread to other parts of the body after surgery
• You have received any anti-cancer treatment (such as chemotherapy or radiation) after your surgery
• You have received any other experimental treatment within the past 4 weeks
• You have previously been treated with a type of drug called a LAG-3 blocker
• You are currently having a serious side effect from a previous immune therapy drug (called a PD-1/PD-L1 blocker), specifically a serious (grade 3 or higher) immune-related reaction
• You have an active or serious autoimmune disease (such as lupus, multiple sclerosis, inflammatory bowel disease, or similar conditions) that may flare up or require immune-suppressing treatment
• You have active or recent lung inflammation (pneumonitis) that required steroid treatment in the past 5 years
• You have active hepatitis B or hepatitis C infection that is not controlled
• You are currently on dialysis for kidney failure
• You have a current or past history of heart muscle inflammation (myocarditis)
• You are currently taking immune-suppressing medicines or high-dose steroids (above a certain level — confirm with trial site)
• You are currently receiving any other cancer treatment, including certain hormone-blocking therapies
• You have received a live vaccine (such as chickenpox or yellow fever) within the past 30 days before joining
• You have had major surgery within 3 weeks before joining the trial
• You have high-grade cancer remaining in the bladder (for patients whose original cancer was in the upper urinary tract)

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