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Study | Clinical trial | Design | No. | Median age (y, range) | Follow-up time (mo) | Prior treatments (no.) | Drugs | ORR/CR/PR/SD/PFS/OS (%) | All-/≥3 AEs (%) |
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Herrera et al. [28] | NCT02572167 | Nonrandomised, open-label, multicenter, single-arm, phase 1/2 | 62 | 36 (18–69) | 7.8 | No BV + ASCT (62) | Nivolumab + BV | 82/61/21/8/NA/NA | 98/31 |
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Ansell et al. [29] | NCT01592370 (Cohort 1) | Dose escalation and expansion cohorts, phase 1 | 23 | 35 (20–54) | 10 | Prior BV + ASCT (15); Prior BV (3); No BV + ASCT (5); | Nivolumab | All-87/17/70/13/86(6-mo)/91(1-y) Prior BV + ASCT-87/7/80/13/86/NA Prior BV-100/NA/100/NA/NA/NA No BV + ASCT-80/60/20/20/80/NA | 96/52 |
Ansell et al. [30] | NCT01592370 (Cohort 2) | 31 | 35 (20–54) | 11.4 | Prior ASCT (31) | Nivolumab + IPI | 74/19/55/10/NA/NA | NA/NA |
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Armand et al. [31] | NCT02181738 (Cohort A) | Multicentre, noncomparative, multicohort, single-arm, open-label, phase 2 | 63 | 33 (18–65)
| 18 | No BV + ASCT (63) | Nivolumab | 65/29/37/24/PFS:77(6-mo); 55(1-y)/OS:99(6-mo); 95(1-y) | 75/11 |
NCT02181738 (Cohort B) | 80 | 37 (18–72) | | Prior BV + ASCT (80) | 68/13/55/21/77(6-mo)/OS:93(1-y) | 91/30 |
NCT02181738 (Cohort C) | 100 | 32 (19–69) | | Prior BV + ASCT (100) | 73/12/61/15/PFS:77(6-mo)/OS:94(6-mo); 90(1-y) | 68/19 |
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Diefenbach et al. [32] | NCT01896999 | Multicohort, phase 1 | 8 | 46 (25–53) | NA | Prior ASCT/BV (8) | Nivolumab + BV | 100/62/23/NA/NA/NA | NA/NA |
|
Armand et al. [33] | NCT01953692 | Multicohort, open-label, single-arm, phase 1b | 31 | 32 (20–67) | 17 | Prior BV + ASCT (31) | Pembrolizumab | 65/16/48/23/69(1-y)/87(1-y) | 97/16 |
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Chen et al. [34] | NCT02453594 (Cohort 1) | Multicenter, single-arm, phase 2 | 69 | 34 (19–64) | 10.1 | Prior BV + ASCT (69) | Pembrolizumab | 74/22/52/16/72(6-mo)/99.5(6-mo) | 29/NA |
NCT02453594 (Cohort 2) | 81 | 40 (20–76) | | Prior BV (81) | 64/25/40/12/72(6-mo)/99.5(6-mo) | |
NCT02453594 (Cohort 3) | 60 | 32 (18–73) | | Prior ASCT (60) | 70/20/50/17/72(6-mo)/99.5(6-mo) | |
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Maruyama et al. [35] | JapicCTI-142755 | Nonrandomised, open-label, multicentre phase 2 | 17 | 63 (29–83) | 9.8 | Prior BV (17) | Nivolumab | a: 81/25/56/6/60(6-mo)/100(6-mo) b: 63/19/44/19/60(6-mo)/100(6-mo) | 100/25 |
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Shi et al. [36] | NCT03114683 | Single-arm, open-label, multicenter, phase 2 | 92 | 33 (28–43) | 10.5 | Prior ASCT/BV (92) | Sintilimab | 80.4/34/47/17/77.6(6-mo)/NA | 93/18 |
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