Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)

To be considered for this study, you would need to have been diagnosed with muscle-invasive bladder cancer that has not spread to other parts of your body. Your doctors would need to confirm that you are generally well enough to have the standard chemoradiotherapy treatment.

There are also some specific health checks the doctors will do to make sure you are suitable for the study treatments. For women, if you are able to have children, you would need to use effective contraception during the study and for a period afterwards. Similarly, for men, you would need to use contraception or avoid fathering a child during the study and for a period after treatment.

Some conditions might mean you can't join, for example, if the cancer has spread within your bladder in a specific way, or if you have cancer in other parts of your waterworks system outside the bladder when you join the study. The study team will carefully review all your medical information to see if this study is right for you.

If you decide to take part, you would have clinic visits for examinations and tests, including blood tests and scans, to monitor your health and the cancer. You would receive either the standard chemoradiotherapy (which involves chemotherapy drugs like cisplatin or gemcitabine, and conventional or hypofractionated radiotherapy) or the chemoradiotherapy plus pembrolizumab. Some people might receive a placebo alongside their CRT.

The study involves regular treatments and follow-up appointments over a period of time to track how you are doing. The total duration of your participation would be discussed with you by the study team, typically involving initial treatment and then follow-up for several months or longer. Each treatment cycle and assessment will be carefully explained.