Phase 4 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 aged 18 or older at the time of signing the consent form
• People with a laboratory-confirmed diagnosis of urothelial carcinoma (a type of cancer affecting the bladder or upper urinary tract) that has spread to nearby lymph nodes and/or to other parts of the body, with the diagnosis made within 90 days of the planned treatment start date
• People whose cancer is primarily urothelial carcinoma, even if it has some squamous or sarcomatoid features mixed in, as long as those variant features make up less than half of the tumour
• People who are willing to undergo surgery to remove the bladder or ureter (if the cancer responds well to treatment) and whose surgeon considers them a suitable surgical candidate
• People with a general health/activity level rated as 0, 1, or 2 on a standard medical scale (meaning they are fully active, have some limitations but can care for themselves, or are up and about more than half the day)
• People whose recent blood test results (taken within 28 days before joining) show that blood counts, liver function, and kidney function meet the minimum levels required by the trial
• People who have had chemotherapy in the past for a reason other than bladder or urinary tract cancer, as long as that treatment ended more than 24 months ago
• People who have fully or mostly recovered from any side effects of prior surgery (side effects must be at a mild or resolved level before joining)
• People who are willing and able to sign the consent form, complete questionnaires (with help if needed), provide blood and tissue samples for research, and return to the trial site for follow-up visits

Who may not be able to join:

• People whose cancer has certain specific tumour types making up more than half the sample, or any amount of neuroendocrine, micropapillary, or signet ring cell features
• People who have previously received systemic (whole-body) chemotherapy for bladder or urinary tract cancer at any time (note: treatments applied directly inside the bladder may not count — confirm with trial site)
• People with another active cancer that has been progressing or required a change in treatment in the last 24 months (some exceptions apply for certain fully treated skin, cervical, breast, or prostate cancers — confirm with trial site)
• People who have received systemic chemotherapy or certain targeted drug therapies within the past 2 years (hormonal therapies may be an exception — confirm with trial site)
• People with a history of uncontrolled adrenal gland problems
• People who have had serious heart or blood vessel events in the past 6 months, including unstable chest pain, heart attack, dangerous heart rhythm problems, cardiac arrest, severe heart failure, stroke, or blood clots in the lungs or veins
• People with known active tuberculosis
• People taking immunosuppressive medications following an organ or tissue transplant
• People with an autoimmune disease (where the immune system attacks the body) that requires ongoing systemic medical treatment
• People with known serious liver disease that would prevent participation in the treatment plan used in this trial
• People with HIV infection, unless they have been stable on anti-HIV medication for at least 6 months, have had no serious infections, and have adequate immune cell counts (confirm with trial site)
• People with known active hepatitis B or C infection (some exceptions apply for people with past hepatitis C or hepatitis B who meet specific test criteria — confirm with trial site)
• People with a known active urinary tract infection at the time of joining (people who have been symptom-free for 7 days with negative test results may be eligible — confirm with trial site)
• People with active, uncontrolled infections of the urinary or genital area (fungal nail or skin infections are not excluded; active shingles is excluded)
• People with known lung inflammation (interstitial lung disease or active non-infectious pneumonitis)
• People with other serious uncontrolled illnesses or mental health/social situations that could affect their ability to follow the trial requirements
• People with a history of certain bowel or abdominal conditions (such as acute diverticulitis, internal abdominal abscess, bowel obstruction, or abdominal spread of cancer) that increase the risk of bowel perforation
• People with a known history of poor wound healing, such as chronic skin ulcers, stomach ulcers, or wounds that have not healed
• People who have ever had radiotherapy to the pelvis
• People who have received a live virus vaccine within 30 days before the planned treatment start
• People with an active infection that required intravenous (IV) antibiotic or antiviral treatment within 30 days before the planned treatment start
• People who have previously been treated with certain immunotherapy drugs that target specific immune system pathways (including anti-PD-1, anti-PD-L1, anti-CTLA-4, and similar therapies)
• People who have had severe (grade 3 or higher) toxic reactions to certain anti-inflammatory biological treatments (anti-TNF or anti-IL-6 agents)
• People still experiencing significant side effects from cancer treatment received more than 24 months ago (minor lasting effects such as hair loss or skin colour changes may not be excluded — confirm with trial site)
• People who need to take immunosuppressive medications (such as high-dose steroids, methotrexate, cyclosporine, or similar drugs) — some inhaled, topical, or low-dose forms may be permitted (confirm with trial site)
• People with a history of serious allergic reactions to protein-based treatments or significant drug allergies (such as anaphylaxis or immune-related blood problems)
• People who are currently participating in another clinical trial involving an investigational treatment, or who have done so within the past 4 weeks
• People who have not recovered from major surgery or a serious injury within at least 14 days before joining (note: bladder tumour removal via scope is not considered major surgery in this context)
• People who are pregnant or breastfeeding
• People who are capable of becoming pregnant or fathering a child and are unwilling to use adequate contraception during the trial
• People for whom the trial doctor believes participation would not be in their best interest or could affect their wellbeing
• People who are unlikely to be able to follow the trial requirements or return for scheduled visits and follow-up

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