Phase 2 Bladder 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
• People who have been diagnosed with bladder cancer that is mainly a type called urothelial carcinoma (certain mixed cell types are allowed, but not small cell type)
• People whose cancer is at a stage classified as T2–T3, with no spread to lymph nodes or other parts of the body, confirmed through surgery, scans, or physical examination
• People who have had a recent PET scan (within 6 weeks of starting treatment) showing no cancer spread to lymph nodes or elsewhere in the body
• People who have had a surgical procedure to remove bladder tumour tissue (called TURBT) within 8 weeks before starting treatment — or, if the procedure was done more than 8 weeks ago, a recent internal camera examination of the bladder showing no remaining tumour
• People with a life expectancy of more than 6 months
• People who are reasonably active and able to carry out daily activities (as rated by a standard medical scale — confirm with trial site)
• People who have had another type of cancer in the past, provided it was treated with the aim of curing it at least 3 years ago with no sign of return, or if untreated, it is a slow-growing cancer unlikely to cause harm (such as certain low-risk prostate cancers)
• People whose overall health is considered suitable to receive chemotherapy combined with a targeted type of radiation therapy to the pelvis, as agreed by both the radiation and medical oncology doctors involved
• People who are willing and able to give written consent to participate
• Women who could become pregnant, and men who are sexually active with women who could become pregnant, must be willing to use highly effective contraception during and for a set period after the trial (details to confirm with trial site)
• People with healthy enough blood counts, liver function, and kidney function, confirmed by blood tests taken within 7 days of starting the trial — specific values include: normal-range bilirubin, liver enzymes, clotting levels, platelet count, haemoglobin, white blood cell count, and kidney filtration rate above a minimum threshold (confirm exact values with trial site)

Who may not be able to join:

• People who have previously received systemic (whole-body) treatment for any urothelial (bladder-type) cancer
• People who have had radiation therapy to the pelvis in the past
• People who have taken part in another clinical trial or received an experimental treatment within approximately 4 weeks (or longer, depending on the drug) before enrolling
• People who have been diagnosed with another cancer within the past 3 years — with some exceptions for certain low-risk prostate cancers, successfully treated early-stage cancers, or cancers with a very low risk of spreading (confirm with trial site)
• People with existing medical conditions that would make the planned treatment unsafe (such as a history of serious immune-related reactions, lung inflammation, or bowel inflammation)
• People with a history of severe allergic reactions to certain types of laboratory-made antibody treatments
• People with a history of autoimmune diseases (conditions where the immune system attacks the body), such as lupus, rheumatoid arthritis, multiple sclerosis, or inflammatory bowel disease — though people with stable thyroid conditions or well-controlled Type 1 diabetes managed with insulin may still be eligible (confirm with trial site)
• People with active tuberculosis
• People who have previously been treated with certain immunotherapy drugs that target specific immune checkpoint proteins (such as PD-1, PD-L1, PD-L2, CD137, or CTLA-4 pathways)
• People currently taking or recently having taken steroid medications or other drugs that suppress the immune system (within the past 2 weeks), or who are expected to need such medications during the trial
• People with an autoimmune disease that has required systemic treatment within the past 2 years
• People who have received or will receive a live vaccine within 4 weeks before starting the trial (COVID-19 vaccines are excepted; certain flu vaccine types must also be avoided — confirm details with trial site)
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, drug-related lung inflammation, or active lung inflammation seen on a chest scan
• People with an active infection currently being treated with intravenous antibiotics
• People who have taken antibiotic treatment (by mouth or intravenously) within 2 weeks before starting the trial — though people taking antibiotics for prevention purposes may still be eligible (confirm with trial site)
• People with significant heart disease, such as a heart attack within the past 3 months, unstable heart rhythm, or unstable chest pain — people with known heart disease or reduced heart pumping function may still be eligible if their condition is well managed (confirm with trial site)
• People who have had a major surgical procedure within 28 days before starting the trial, or who are expected to need major surgery during the trial
• People who have previously had a bone marrow or organ transplant from a donor
• People with any other serious medical condition, abnormal test result, or health finding that could make participation unsafe or affect the reliability of the trial results
• People with a known history of HIV
• People with active Hepatitis B or Hepatitis C infection
• People who are unwilling or unable to sign a consent form

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