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 choose to take part voluntarily
• People aged between 18 and 80 years old
• People with a good general level of physical functioning (able to carry out normal daily activities with at most minor limitations, as rated by a doctor)
• People who have been diagnosed through a tissue biopsy with a type of urinary tract cancer called urothelial carcinoma that cannot be surgically removed and has either spread locally or to other parts of the body — this includes cancers of the bladder, kidney pelvis, or ureter; mixed cell types are allowed if the urothelial carcinoma type makes up more than half of the tumour
• People who have not yet received any treatment aimed at the whole body (such as chemotherapy or immunotherapy) for this advanced or metastatic cancer
• People who have at least one measurable tumour that meets specific measurement standards (called RECIST v1.1); if the person has previously had radiotherapy, the measurable tumour must be outside the treated area or must have clearly grown since the radiotherapy
• People with a life expectancy of more than 12 weeks
• People whose blood counts and organ functions (such as liver and kidneys) meet the required levels as assessed by a doctor
• People who agree to use contraception until at least 180 days after the last dose of the study treatment
• People who are able to understand and follow the study schedule, including visits, treatments, and tests

Who may not be able to join:

• People who have had another cancer diagnosed within the 3 years before joining the trial
• People who have an active autoimmune disease that has required whole-body (systemic) treatment within the past 2 years, or who have taken high-dose steroid medication (more than 10mg per day of prednisolone or equivalent) or other immune-suppressing medicines
• People who have had a serious heart or blood vessel event — such as a stroke, heart attack, or blood clot — within the 6 months before joining
• People who have had major surgery within 28 days before joining; received a live vaccine within 28 days before joining or who plan to receive one during the study; had radiotherapy or bladder infusion therapy within 21 days before joining; or taken certain strong medications that affect how the body processes drugs (strong CYP3A4 inhibitors) within 14 days before joining (confirm specific medications with the trial site)
• People who have had fluid build-up around the lungs or in the abdomen requiring treatment in the past 14 days; severe uncontrolled bone pain or spinal cord pressure caused by cancer in the past 14 days; or an active infection requiring antibiotic treatment in the past 7 days
• People who have previously been treated with certain immunotherapy drugs (anti-PD-1, anti-PD-L1/PD-L2, or anti-CTLA-4); people who have previously received a therapy specifically targeting a protein called Nectin-4, or a type of drug called an ADC that uses MMAE; or people who have had a stem cell or organ transplant from another person
• People who still have side effects from previous cancer treatment (such as chemotherapy, radiotherapy, or surgery) that have not improved to a mild or resolved level, with the exception of hair loss or skin darkening
• People with severe dry eyes, active inflammation of the cornea, corneal ulcers, or other eye conditions that a doctor considers make participation unsuitable
• People who already have nerve damage rated at a moderate level or worse (grade 2 or above) before joining
• People with other serious illnesses that are not well controlled
• People who have cancer that has spread to the brain or the membranes surrounding the brain or spinal cord
• People who test positive for active hepatitis B virus, active hepatitis C virus, or HIV (confirm testing criteria with trial site)
• People with a known allergy to the study drug or any of its ingredients
• People with substance misuse issues or a psychiatric condition that could affect their ability to follow the study requirements
• People whom the lead doctor considers unsuitable for the study for other reasons

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