Study on the Effectiveness and Safety of Pembrolizumab with BCG in High-Risk Non-Muscle Invasive Bladder Cancer

Inclusion Criteria

• Have a confirmed diagnosis of high-risk non-muscle invasive bladder cancer (HR NMIBC) based on specific medical reviews.
• Have undergone a procedure to remove all visible tumors from the bladder.
• Have provided a tissue sample for analysis.
• Have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
• Have adequate organ function as determined by medical tests.
• Male participants must agree to use contraception or remain abstinent during treatment and for at least 7 days after the last BCG dose.
• Female participants must not be pregnant or breastfeeding and must agree to use effective contraception or remain abstinent during treatment and for at least 7 days after the last BCG dose or 120 days after the last pembrolizumab dose, whichever is longer.

BCG Post-induction Cohort (Cohort A) Only:

• Have been treated with a full course of BCG induction therapy for HR NMIBC.
• Have persistent or recurrent HR NMIBC after BCG induction therapy.

Exclusion Criteria

• Have a history of or current advanced bladder cancer that has spread to the muscle or beyond.
• Have cancer in other parts of the urinary system or a history of such cancer.
• Have received prior treatment with certain immune therapies or investigational drugs within 4 weeks before starting the study.
• Are currently in another clinical trial or have used an investigational device within 4 weeks before starting the study.
• Have an immune deficiency or are on long-term steroid or immunosuppressive therapy within 7 days before starting the study.
• Have another progressing cancer or one that required treatment in the past 3 years.
• Have an active autoimmune disease needing treatment in the past 2 years.
• Have a history of lung disease requiring steroids or current lung disease.
• Have certain conditions that prevent BCG treatment, like previous severe reactions to BCG.
• Have an active infection needing treatment.
• Have a known history of HIV, Hepatitis B, or active Hepatitis C.
• Have active tuberculosis.
• Have had a tissue or organ transplant.
• Cannot undergo imaging with IV contrast due to contraindications.

BCG Post-induction Cohort (Cohort A) Only:

• Have persistent T1 disease after BCG induction therapy.

BCG Naïve Cohort (Cohort B) Only:

• Have received any BCG treatment for NMIBC within the past 2 years before joining the study.