Phase 1 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:

For Cohorts A and B (non-muscle-invasive bladder cancer):

• People who have high-grade bladder cancer (that has not grown into the bladder muscle) of a type called urothelial carcinoma, which has not responded to a full course of BCG treatment (a type of bladder cancer immunotherapy)
• People whose cancer type and stage have been confirmed by the pathology department at Memorial Sloan Kettering (MSK)
• People whose tumours are mainly urothelial carcinoma, even if there is a small amount of another cancer cell type mixed in
• People with a specific type of bladder cancer called CIS (carcinoma in situ), where the CIS was visible on the most recent bladder examination
• People whose BCG treatment is considered "adequate," meaning they completed at least five of six doses of an initial course plus at least two of three maintenance doses, or at least two of six doses of a second full course
• People whose cancer is considered unresponsive to BCG, meaning: CIS that persists or comes back within 12 months of finishing BCG; or high-grade cancer that comes back within 6 months of finishing BCG; or high-grade T1 cancer found at the first check-up after BCG treatment
• People who have had a complete surgical removal of visible papillary tumours (if present), with the cancer confirmed not to have spread into the deeper bladder muscle layer
• People whose most recent bladder examination was performed within the last 6 months
• People with no sign of cancer in the upper urinary tract (kidneys or ureters), confirmed by imaging or camera examination
• People who have decided not to have their bladder surgically removed, or who have been assessed by their surgeon as not suitable for that operation — reasons may include heart conditions, serious lung disease, poor general health, or prior major abdominal surgery

For Cohort C (muscle-invasive bladder cancer):

• People who have bladder cancer that has grown into the bladder muscle (staged cT2–T4a, N0–2) with urothelial carcinoma as the main cancer type, confirmed by MSK pathology
• People who are willing to undergo a standard examination under anaesthetic or a bladder camera check within four weeks before a planned bladder removal surgery
• People who have already received 3 to 4 cycles of a specific combination treatment called Enfortumab Vedotin and pembrolizumab before the trial

For all participants:

• People aged 18 or older at the time of signing the consent form
• People who are in reasonably good general health, as measured by standard medical scoring tools (confirm with trial site)
• People whose recent blood test results (within the past 28 days) meet minimum levels for blood cells, kidney function, and liver function (confirm with trial site for specific values)
• Women who could become pregnant must have a negative pregnancy blood test within 72 hours before starting treatment
• People who are able and willing to use effective contraception throughout the study and for 120 days after the last dose, if there is any possibility of pregnancy
• Male participants must agree not to donate sperm during and after the study
• People who are able to follow the treatment schedule as agreed with their doctor

Who may not be able to join:

For Cohorts A and B:

• People who have had, or are currently being treated for, bladder cancer that has grown into the bladder muscle or spread to other parts of the body
• People who have bladder cancer present outside the bladder (such as in the urethra, ureters, or kidney)
• People currently receiving other cancer treatments (with some exceptions for topical therapies applied directly inside the bladder)
• People who have received any bladder-instilled chemotherapy or immunotherapy between their most recent bladder examination and the start of the trial (a single dose given during that examination may be acceptable — confirm with trial site)

For all participants:

• People who have received any other pre-surgery cancer treatment besides Enfortumab Vedotin and pembrolizumab for muscle-invasive bladder cancer
• People who have had chemotherapy, targeted therapy, or radiation within 2 weeks before the first trial dose, or who still have significant side effects from a previous treatment (some exceptions apply for mild nerve-related side effects or hair loss — confirm with trial site)
• People who have had major surgery or have a wound that has not fully healed within 4 weeks before the first trial dose
• People with another cancer that has been active or required treatment in the last three years (exceptions include certain skin cancers, early-stage cervical cancer, and some cases of prostate cancer — confirm with trial site)
• People with an autoimmune disease (where the immune system attacks the body) that has required ongoing medical treatment in the past 2 years (replacement hormone therapies are generally not considered a disqualifying treatment — confirm with trial site)
• People with a known immune system disorder, or who are taking immune-suppressing medicines within 4 weeks before the first dose (low-dose replacement steroids and inhaled or topical steroids may be acceptable — confirm with trial site)
• People with known reasons they cannot receive treatment instilled inside the bladder, such as fever, active urinary tract infection, or significant bleeding in the urine
• People with an active infection requiring treatment, including a urinary tract infection that has not cleared up within 4 weeks before the first dose
• People who have had a serious infection (such as one requiring hospitalisation or causing blood infection) within 4 weeks before the first dose
• People who have had lung inflammation (not caused by infection) that needed steroid treatment, or who currently have lung inflammation
• People with a known HIV infection
• People with active Hepatitis B or Hepatitis C infection (people with past infections that are no longer detectable may still be considered — confirm with trial site)
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial or within 120 days after the last dose
• People who have had a stroke or bleeding in the brain within the 6 months before joining
• People who have had a blood clot in the lungs or another significant blood clot within the 6 months before joining
• People who have received an organ or tissue transplant from another person
• People with any other medical condition, treatment, or situation that the treating doctor believes would make participation unsafe or unsuitable

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