Phase 2 Bladder Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older who have been diagnosed with muscle-invasive bladder cancer (a type of cancer that can also affect the renal pelvis, ureter, or urethra), confirmed by laboratory testing of tissue samples
• People whose cancer has been assessed as clinical stage T2–T4 with certain lymph node involvement but no spread to distant organs, or a specific earlier-stage cancer (cT1) with more extensive lymph node involvement, and no distant spread
• People who have tissue samples available (tumour blocks or up to 20 unstained slides) for laboratory analysis
• People whose muscle-invasive bladder cancer has been confirmed by a surgical procedure called TURBT at the enrolling hospital
• People who have evidence of cancer involvement in nearby lymph nodes, either confirmed by a needle biopsy or seen on imaging scans
• People who a specialist urologic oncologist at the trial site has assessed as medically suitable for a surgical procedure to remove the bladder (radical cystectomy), provided treatment response has been achieved
• People who are able to tolerate platinum-based chemotherapy as well as those who are not — both groups may be considered
• People who have not previously received any treatment for muscle-invasive or metastatic urothelial cancer
• People with a good general health and activity level, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work), assessed within 7 days before the first treatment dose
• People whose kidneys are functioning at an acceptable level, as measured by a specific blood test result (eGFR of 30 ml/min/1.73 m² or above)
• People who are willing and able to sign a written consent form for the trial
• Male participants who agree to use contraception during treatment and for at least 120 days after the last dose, and who agree not to donate sperm during this period
• Female participants who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use contraception during treatment and for at least 90 days after the last dose
• People whose blood counts, liver function, kidney function, and blood clotting results fall within the acceptable ranges required by the trial, confirmed by blood tests taken within 14 days before starting treatment

Who may not be able to join:

• People with moderate to severe heart failure (classified as NYHA class III or IV)
• People who have had a heart attack, severe chest pain, heart bypass surgery, serious heart failure, stroke, or mini-stroke within the 6 months before starting treatment
• People with significant ongoing irregular heart rhythms (grade 2 or higher), though stable, medically controlled atrial fibrillation is allowed
• People who already have moderate or severe nerve damage causing loss of sensation (sensory neuropathy grade 2 or higher)
• People who have had a major surgical procedure within 28 days before starting treatment, or who are expected to need major surgery during the trial (other than bladder removal surgery — minor procedures such as biopsies or urinary tract procedures are not considered major surgery)
• People with known psychiatric conditions or substance use disorders that would make it difficult to follow the trial requirements
• Women who could become pregnant and have a positive pregnancy test within 72 hours before being assigned to treatment
• People who are currently enrolled in another treatment-focused clinical trial (participation in quality-of-life or dietary survey studies is allowed)
• People who have previously been treated with certain types of immunotherapy drugs that target specific immune system pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or related therapies)
• People who have received prior systemic cancer treatment — including investigational drugs, antibody-drug treatments for bladder cancer, or systemic chemotherapy — within 4 weeks before enrolment (prior treatment applied directly inside the bladder is allowed)
• People who have had radiation therapy within 2 weeks before starting the trial, or who have not fully recovered from radiation side effects
• People who have received a live or live-attenuated vaccine (such as measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, or live nasal flu spray) within 30 days before the first dose (injected flu vaccines and COVID-19 vaccines are generally permitted — confirm with the trial site)
• People who have received BCG treatment directly into the bladder within 4 weeks before starting treatment
• People who have a condition that weakens the immune system, or who are taking high-dose steroid medications or other immune-suppressing treatments within 7 days before the first dose
• People with poorly controlled HIV infection or AIDS-related illness, or who have had a serious HIV-related infection in the past 12 months (people with HIV and a CD4 count of 350 or above may be considered with approval from the principal investigator — confirm with the trial site)
• People with poorly controlled diabetes, defined by specific blood sugar test results
• People with a history of certain autoimmune diseases (conditions where the immune system attacks the body), such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, or similar conditions — though some people with well-controlled thyroid conditions or stable Type 1 diabetes on insulin may still be considered (confirm with trial site)
• People with a history of, or current, serious lung conditions such as pulmonary fibrosis, pneumonitis, or interstitial lung disease requiring steroids
• People with active hepatitis B or hepatitis C infection (people with past, resolved hepatitis B or successfully treated hepatitis C may be considered — confirm with trial site)
• People with active tuberculosis or active BCG infection
• People who have had a serious infection requiring hospitalisation within 4 weeks before starting treatment
• People showing signs or symptoms of an active infection within 2 weeks before starting treatment
• People who have been taking antibiotic treatment for an active infection within 2 weeks before starting treatment (those on preventive antibiotics may still be considered)
• People who have previously had a bone marrow or solid organ transplant from another person
• People who still have significant side effects from previous cancer treatments (other than hair loss) that have not settled to a mild level
• People with certain active blood or bone marrow disorders, such as acute leukaemia or certain types of lymphoma
• People with known significant liver disease, including active hepatitis, cirrhosis, or inherited liver conditions
• People with active eye conditions involving the cornea, such as active keratitis or a history of corneal ulcers
• People with certain skin conditions (such as eczema or psoriasis) may be considered only if the condition covers less than 10% of the body, is well controlled with mild topical treatments, and has not flared up in the past 12 months — those with more severe or systemic skin conditions are not eligible
• People who have had another cancer diagnosis within the past 5 years, with some exceptions for certain low-risk or successfully treated cancers (confirm with trial site)

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