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. Author manuscript; available in PMC: 2018 Oct 2.
Published in final edited form as: Urol Oncol. 2017 May 8;36(10):459–468. doi: 10.1016/j.urolonc.2017.04.007

Table 1.

Data reported from phase I to III clinical trials of immune checkpoint inhibitors in urothelial carcinoma

NCT Identifier, Trial Name Agent Target Phase Population Response, OR% (CR%) OS (mo) AEs PD-L1 + definition Refs.
JAVELIN Solid Tumor, NCT01772004 Avelumab PD-L1 Ib Multiple tumor types, UC = 44. 
Metastatic, postplatinum
18.2 (4.5), PD-L1 + : 50 12mo OS: 50.9% Gr ≥ 3 trAE: 11 PD-L1+ ≥5% IC [85]
NCT02108652 IMvigor 210 Atezolizumab PD-L1 II C 1: first-line cisineligible (n = 119) C 1: 24 (7) C 1: 14.8 Cohort 1: Gr 3-4
trAE: 15
PD-L1 IC0: <1% IC C 1: [86]
C 2: Postplatinum (n = 311) PD-L1+: 25 (6)
C 2: 15 (5)
PD-L1+: 18 (6)
C 2: 7.9 Gr 5 trAE: 1
Cohort 2: G3-4 trAE: 16
PD-L1 IC1: ≥1 ≤ 5% IC
PD-L1 IC2/3: ≥5% IC
C 2: [28]
NCT01928394 Nivolumab PD-1 I/II Multiple tumor types (UC = 78) 24.4 (6.4) 9.7 G3-4 trAE: 20.5 PL-L1 + if expression ≥ 1% TC [34, 87]
  CheckMate 032 Nivolumab + Ipiliumab (3/1 and 1/3) CTLA-4 Metastatic, postplatinum G5 trAE: 2.6
N3/I1 (n = 104) 26.0 NR 31.7
N1/I3 (n = 26) 38.5 NR 30.8
NCT02387996
CheckMate 275
Nivolumab PD-1 II Postplatinum, metastatic or locally advanced UC (n = 265) 19.6 (2)
PD-L1 ≥ 5%:
28.4
PD-L1 ≥ 1%:
23.8
PD-L1-: 16.1
8.7 G3-4 trAE: 18
G5 trAE: 1.1
PL-L1 + if expression ≥1% TC (also reported outcomes for PD-L1 ≥ 5%) [88]
NCT01693562 Durvalumab PD-L1 I/II Multiple tumor types (UC = 61)
Metastatic (57 > first line)
31.0%
PD-L1 + : 46.4
PD-L1-: 0
NR G3 trAE: 4.9
G4-5 trAE: 0
PD-L1+ if ≥ 25% of TC or IC [89]
NCT01848834
KEYNOTE-012
Pembrolizumab PD-1 I Multiple tumor types (UC = 33)
Metastatic, 76% > first line
27.6 (10.3)
PD-L1 + : 29-33
PD-L1-: 0-9
12.7 G3 trAE: 9.1
G4-5 tRAE: 0
PD-L1+ if staining in stroma or ≥ 1% TC [90]
NCT02335424
KEYNOTE-052
Pembrolizumab PD-1 II First-line cisplatin-ineligible metastatic or locally advanced (n = 349) 24.0 (6.0)
PD-L1 ≥ 10%:
36.7 (13.3)
PD-L1 ≥ 1%:
25.4 (6.3)
NR Gr ≥ 3 trAE: 16% PD-L1 + if: ≥ 10% combined TC and IC (also reported response if ≥ 1%) [91]
NCT02256436
KEYNOTE-045
Pembrolizumab PD-1 III Second-line postplatinum pembrolizumab (n = 270) vs. paclitaxel, docetaxel, or vinflunine (n = 272) 21.1 (7.0) vs. 11.4 (3.3) 10.3 vs. 7.4 (HR = 0.73, P = 0.002) Gr ≥ 3 trAE: 15 vs. 49 PD-L1 + if: ≥ 10% combined TC and IC [29]

BSC = best supportive care; C1 = cohort 1; C2 = cohort 2; Chemo = chemotherapy; Cis = cisplatin; CR = complete response; DFS = disease free survival; GC = gemcitabine þ cisplatin; GCa = gemcitabine þ carboplatin; MIBC = muscle-invasive bladder cancer; IC = immune cells; NR = not reported; OR = objective response; OS = overall survival; PC = placebo-controlled; PFS = progression free survival; Ref = reference; RPIII = randomized, phase III trial; SD = stable disease; TC = tumor cells; trAE = treatment-related adverse events; UC = urothelial carcinoma.