Table 3.

Select phase III trials using immune checkpoint inhibitors as adjuvant therapy for MIBC.

Trial name	Phase of trial	Experimental arms N; eligibility	Primary endpoints	Findings	Comments
IMvigor010	III	Atezolizumab vs Observation (N = 809) ypT2–4a or ypN+ tumors following neoadjuvant chemotherapy or pT3–4a or pN+ tumors if no neoadjuvant chemotherapy was received.	DFS	Atezolizumab Median DFS = 19.4 mo (95% CI, 15.9-24.8) vs Observation = 16.6 mo (11.2-24.8) (stratified HR 0.89 [95% CI, 0.74-1.08]; P = .24).	Did not meet primary endpoint
CheckMate 274	III	Nivolumab vs Placebo (N = 353 pts to Nivo; PD-L1 ⩾ 1%, n = 140 and 356 pts to Placebo (PD-L1 ⩾ 1%, n = 142); s/p radical surgery within 120 days ± NAC cisplatin or were ineligible/declined cisplatin-based chemo; evidence of UC at high risk of recurrence per pathologic staging, disease-free by imaging, ECOG PS ⩽ 1.	DFS in all randomized pts (ITT population) and in pts with tumor PD-L1 expression ⩾ 1%.	Median DFS ITT: Nivo = 20.8 (16.5-27.6) vs Placebo = 10.8 mo (8.3-13.9); HR = 0.70 (0.55-0.90); P < 0.001; PD-L1 ⩾ 1%: Nivo = 74.5% vs Placebo = 55.7%; HR = 0.55; 98.72% CI, 0.35 to 0.85; P < 0.001	Met primary endpoint; FDA approval 2021
AMBASSADOR (A031501)	III	Pembrolizumab vs Observation (N = 739) +NAC = >/= pT2 and/or N+ or Cis-ineligible or cis-refusal –NAC = >/= pT3 or pN+	Co-primary endpoint: DFS and OS	Enrollment ongoing	Not yet reported

Abbreviations: CI, confidence interval; DFS, disease-free survival; ECOG, Eastern Cooperative Oncology Group; HR, hazard ratio; ITT, intention-to-treat; MIBC, muscle-invasive bladder cancer; N+, node-positive; NAC, neoadjuvant chemotherapy; OS, overall survival; PD-L1, programmed death-ligand 1; PS, Performance Status; pts, patients; UC, urothelial cancer; NR, not reached.