This study focuses on individuals who have a diagnosis of high-risk, non-muscle invasive bladder cancer (also referred to as HR-NMIBC or urothelial cancer). The purpose of the study is to compare the effects of an investigational drug delivery system called TAR-200 in combination with cetrelimab or TAR-200 alone to the effects of intravesical (medicine that is put directly into the bladder) Bacillus Calmette Guérin (BCG) in patients with HR-NMIBC. Investigational means that TAR-200 with or without cetrelimab has not been approved by the U.S. Food and Drug Administration (FDA). TAR-200 is a drug delivery system that is placed into the bladder and releases a drug called gemcitabine (an anti-cancer chemotherapy drug) into the bladder. Cetrelimab is a medicine that may treat certain cancers by working with the immune system (also known as immunotherapy). Participants will be randomly assigned to 1 of 3 treatment groups to receive either TAR-200 in combination with cetrelimab, TAR-200 alone, or intravesical BCG therapy alone.
What is the full name of this clinical trial?
17000139BLC3002: A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and 17000139BLC3002 Safety of TAR-200 in Combination with Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin in Participants with BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer
Edwin Posadas, Hyung Kim, Jun Gong, Mitra Anirban