Study on Pembrolizumab with Chemotherapy vs. Placebo with Chemotherapy for Muscle-Invasive Bladder Cancer

Inclusion Criteria

• Diagnosed with muscle-invasive bladder cancer (MIBC) with at least 50% of the cancer being urothelial carcinoma.
• Cancer has not spread to distant parts of the body, as confirmed by imaging tests like CT or MRI.
• Eligible for surgery to remove the bladder and nearby lymph nodes.
• In good overall health, with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have good organ function based on medical tests.
• Agree to use contraception during the study if of childbearing potential.

Exclusion Criteria

• Have another active cancer that has required treatment in the last 3 years, with some exceptions.
• Have received any previous systemic treatment for muscle-invasive bladder cancer, except for certain treatments for non-invasive bladder cancer.
• Have cancer that has spread to distant lymph nodes or other parts of the body.
• Not eligible for cisplatin treatment based on specific medical criteria.
• Have had previous cancer treatments, including investigational drugs or radiation to the bladder, within the last 3 years.
• Have had surgery to partially remove the bladder.
• Have received a live vaccine within 30 days before starting the study treatment.
• Have a diagnosis of an immune system deficiency or infections like HIV, Hepatitis B, or active Hepatitis C.
• Have a psychiatric or substance abuse disorder that could interfere with study participation.
• Have had a tissue or organ transplant.