Table 4.

Select phase III clinical trials for high-risk NMIBC.

Clinicaltrials.gov	Phase of trial	Name of trial	Experimental arms	Primary endpoints	N
NCT03528694	III	Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer (POTOMAC)	Durvalumab + BCG (induction and maintenance) vs induction vs BCG	DFS	N = 1019 pts
NCT04149574	III	A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (CheckMate 7G8)	Nivolumab + BCG vs Placebo + BCG	Event-free survival	N = 700 pts
NCT03711032	III	Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)	Pembrolizumab + BCG post-induction, reduced/full maintenance vs BCG alone	Complete response rates and Event-free survival	N = 1525 pts
NCT03799835	III	Atezolizumab Plus One-year BCG Bladder Instillation in BCG-Naive High-Risk Non-muscle Invasive Bladder Cancer Patients (ALBAN)	Atezolizumab + BCG vs Placebo + BCG	Recurrence-free survival	N = 516 pts

Abbreviations: BCG, Bacillus Calmette-Guerin; DFS, disease-free survival; HR, hazard ratio; NMIBC, non-muscle-invasive bladder cancer; pts, patients.