NCT03711032

Who might be able to join this trial:

• You have been diagnosed with high-risk bladder cancer that has not grown into the muscle wall (specifically types called T1, high-grade Ta, and/or CIS), confirmed by a specialist review
• You have had a procedure to look inside your bladder and remove all removable tumour tissue (a cystoscopy/TURBT)
• You have provided a tissue sample for testing as part of the study
• Your general health and ability to carry out daily activities falls within an acceptable range (a standard health scale scored 0, 1, or 2)
• Your organs (such as kidneys and liver) are functioning well enough to participate
• If you are male: you either do not have heterosexual intercourse, or you agree to use contraception during treatment and for at least 7 days after the last BCG treatment
• If you are female: you are not pregnant, not breastfeeding, and either cannot become pregnant, or you agree to use highly effective contraception or abstain from heterosexual intercourse during treatment and for at least 7 days after the last BCG treatment, or 120 days after the last dose of the study drug pembrolizumab — whichever is later

For Cohort A (patients who have already had BCG treatment) only:

• You have completed one full course of BCG treatment for your bladder cancer
• After completing that BCG treatment, your cancer has either persisted or come back

Who may not be able to join:

• You have had, or currently have, bladder cancer that has spread into the deeper muscle layers or to other parts of the body
• You have or have had this type of bladder cancer in other parts of your urinary tract (such as the urethra, ureter, or kidney)
• You have previously been treated with certain immune-based therapies that target specific proteins on immune cells (such as anti-PD-1 or anti-PD-L1 drugs)
• You have received any systemic cancer treatment or experimental treatment within the last 4 weeks before starting the study
• You are currently in, or have recently taken part in, another clinical trial or used an experimental medical device within the last 4 weeks
• You have a condition that weakens your immune system, or you are taking steroid tablets or other immune-suppressing medicines within 7 days before starting the study
• You have another cancer (besides the one being studied) that is growing or being actively treated and has been in the last 3 years
• You have an active autoimmune disease (where your immune system attacks your own body) that has needed treatment in the last 2 years
• You have a history of, or currently have, a lung condition called pneumonitis or interstitial lung disease that needed steroid treatment
• You have had a serious reaction to BCG in the past, such as a severe infection, or you cannot have BCG for other medical reasons (confirm with trial site)
• You currently have an active infection that requires antibiotic or antifungal treatment
• You have a known history of HIV infection
• You have a known history of Hepatitis B, or currently have an active Hepatitis C infection
• You currently have active tuberculosis (TB)
• You have received an organ or tissue transplant from another person
• You are unable to have a type of scan that uses an injected contrast dye (for example, due to an allergy or kidney problems)

For Cohort A only:

• Your T1 bladder cancer is still present after completing a full course of BCG treatment

For Cohort B (BCG-naïve patients) only:

• You have received any BCG treatment for your bladder cancer in the past 2 years

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