A Phase 3 Randomized Comparator-controlled Study of the Efficacy and Safety of Pembro in Comb. with BCG in Participants with HR Non-muscle Invasive Bladder Cancer (HR NMIBC) that is Persistent or Recurrent Following BCG Induction

Brief description of study

The purpose of the study is to test the safety of the study drugs, pembrolizumab in combination with Bacillus Calmette-Guerin (BCG) and we want to see how your body handles pembrolizumab and BCG. We want to how well pembrolizumab in combination with BCG works compared to BCG alone. We also want to see if pembrolizumab helps patients getting BCG have a better quality of life and if pembrolizumab helps patients getting BCG live longer. Pembrolizumab (MK-3475), also known as KEYTRUDA®, works by stimulating your body’s immune system by attacking a protein called PD-1, which is involved in the growth of certain cancers.BCG are bacteria which have been specially altered, so that it can be used as a medicine to treat bladder cancer or to prevent bladder cancer from coming back after bladder surgery. Pembrolizumab has been approved by certain health authorities for the treatment of some cancers. However, pembrolizumab has not been approved to treat your specific type of cancer by the United States Food and Drug Administration (FDA) or any other health or regulatory authority in other countries, which means it is investigational. BCG has been approved for patients with your type of bladder cancer. Getting pembrolizumab and BCG together is also considered experimental.


Clinical Study Identifier: s18-00374
ClinicalTrials.gov Identifier: NCT03711032
Principal Investigator: William C Huang.
Other Investigators: Victor Ricardo Adorno Febles, Anthony Corcoran, James S Wysock, Katie S. Murray, Scot Niglio, Mary K O'Keeffe, Aaron Edward Katz, Minas Platon Economides, Wei Phin Tan, Hank Ng, David R. Wise.


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