Table 1 Summary of results of clinical trials with anti-PD-1/PD-L1 as single agents (only data for anti-PD-1/PD-L1 arms are reported)
Study name/code (NCT) | Study phase | Type of Cancer | Treatment | Patients evaluated for response | Time to first tumor assessment (weeks) | ORR by RECIST criteria | ORR by immune-related response criteria | Rate of patients treated beyond progression | ORR after initial PD | First author and date of publication |
|---|---|---|---|---|---|---|---|---|---|---|
15–286 (NCT02673333) | 2 | Adrenocortical carcinoma | Pembrolizumab | 39 | 9 | 9 (23.1%) | Not reported | Not reported | 2 (5.1%) | Raj 2020 [12] |
16–032 (NCT02730130) | 2 | Breast cancer | Pembrolizumab plus RT | 17 | 13 | 3 (17.6%) | 3 (17.6%) | Not reported | Not reported | Ho 2019 [13] |
2014–1315 (NCT02364076) | 2 | Thymic carcinoma | Pembrolizumab | 40 | 6 | 9 (22.5%) | Not reported | Not reported | 0 (0%) | Giaccone 2018 [14] |
20,151,049 (NCT02658019) | 2 | Hepatocellular carcinoma | Pembrolizumab | 28 | 9 | 9 (32.1%) | Not reported | 15 (53.6%) | 1 (3.6%) | Feun 2019 [15] |
Alliance A091401 (NCT02500797) | 2 | Sarcoma | Nivolumab | 38 | 6 | 2 (5.3%) | Not reported | 18 (47.4%) | 0 (0%) | D’Angelo 2018 [16] |
Attraction-2 (NCT02267343) | 3 | Gastric cancer | Nivolumab | 268 | 6 | 30 (11.2%) | Not reported | 95 (35.5%) | Not reported | Kang 2017 [17] |
CD-ON-MEDI4736–1108 (NCT01693562) | 1/2 | UC | Durvalumab | 42 | 6 | 13 (31.0%) | Not reported | 2 (4.8%) | 2 (4.8%) | Massard 2016 [18] |
NSCLC | 256 | 39 (15.2%) | 99 (38.7%) | Not reported | Antonia 2019 [19] | |||||
CA-210-001 (NCT00729664) | 1 | Advanced solid tumors | Nivolumab | 160 | 6 | 17 (10.6%) | Not reported | Not reported | 4 (2.5%) | Brahmer 2012 [20] |
CheckMate-003 (NCT00730639) | 1 | RCC | Nivolumab | 34 | 8 | 10 (29.4%) | Not reported | Not reported | 3 (8.8%) | MCDermott 2015 [21] |
Melanoma | 107 | 33 (30.8%) | Not reported | Not reported | 4 (3.7%) | Topalian 2014 [22] | ||||
NSCLC | 129 | 22 (17.1%) | Not reported | Not reported | 6 (4.7%) | Gettinger 2015 [23] | ||||
CheckMate-004 (NCT01024231) | 1 | Melanoma | Nivolumab | 30 | 8 | 6 (20.0%) | Not reported | Not reported | 3 (10.0%) | Wolchock 2013 [24] |
CheckMate-010 (NCT01354431) | 2 | RCC | Nivolumab | 168 | 6 | 35 (20.8%) | 38 (22.8%) | 36 (21.4%) | 2 (1.2%)a | Motzer 2015 [25], George 2016 [8], Pignon 2019 [6] |
CheckMate-012 (NCT01454102) | 1 | NSCLC | Nivolumab | 52 | 11 | 12 (23.1%) | Not reported | Not reported | 3 (5.8%) | Gettinger 2016 [26] |
CheckMate-017 (NCT01642004) | 3 | Squamous NSCLC | Nivolumab | 135 | 9 | 27 (20.0%) | Not reported | 27 (20.0%) | 9 (6.7%) | Brahmer 2015 [27] |
CheckMate-025 (NCT01668784) | 3 | RCC | Nivolumab | 406 | 8 | Not reported | Not reported | 153 (37.7%) | 20 (4.9%) | Escudier 2017 [28] |
CheckMate-026 (NCT02041533) | 3 | NSCLC | Nivolumab | 211 | 6 | 55 (26.1%) | Not reported | 77 (36.5%) | Not reported | Carbone 2017 [29] |
CheckMate 032 (NCT01928394) | 1/2 | SCLC | Nivolumab | 98 | 6 | 10 (9.8%) | Not reported | 30 (30.6%) | Not reported | Antonia 2016 [30] |
UC | 78 | 19 (24.4%) | Not reported | 31 (39.7%) | 9 (11.5%) | Sharma 2016 [31] | ||||
CheckMate-037 (NCT01721746) | 3 | Melanoma | Nivolumab | 120 | 9 | 38 (31.7%) | Not reported | 37 (30.8%) | 10 (8.3%) | Weber 2015 [32] |
CheckMate-057 (NCT01673867) | 3 | Non-squamous NSCLC | Nivolumab | 292 | 9 | 56 (19.2%) | Not reported | 71 (24.3%) | 16 (5.5%) | Borghaei 2015 [33] |
CheckMate-063 (NCT01721759) | 2 | Squamous NSCLC | Nivolumab | 117 | 8 | 17 (14.5%) | Not reported | 22 (18.8%) | 4 (3.4%) | Rizvi 2015 [34] |
CheckMate-066 (NCT01721772) | 3 | Melanoma | Nivolumab | 210 | 9 | 84 (40.0%) | Not reported | 54 (25.7%) | 17 (8.1%) | Robert 2015 [35] |
CheckMate-067 (NCT01844505) | 3 | Melanoma | Nivolumab | 316 | 12 | 140 (44.3%) | Not reported | 97 (30.7%) | Not reported | Wolchok 2017 [36] |
CheckMate-141 (NCT02105636) | 3 | HNSCC | Nivolumab | 240 | 9 | Not reported | Not reported | 62 (25.8%) | 3 (1.3%)b | Haddad 2019 [7] |
CheckMate-275 (NCT02387996) | 2 | UC | Nivolumab | 265 | 8 | 52 (19.6%) | Not reported | 70 (26%) | 24 (9.1%) | Sharma 2017 [37] |
FIR (NCT01846416) | 2 | NSCLC | Atezolizumab | 137 | 6 | 30 (21.9%) | 32 (23.4%) | Not reported | 2 (1.5%) | Spigel 2018 [38] |
IMvigor210 (NCT02108652) | 2 | Urothelial cancer | Atezolizumab | 310 | 9 | 45 (15%) | 58 (19%) | 121 (39%) | 21 (6.8%) | Rosenberg 2016 [39] |
IND 121564 (NCT02085070) | 2 | Melanoma | Pembrolizumab | 18 | 8 | 4 (22.2%) | Not reported | 1 (5.6%) | Not reported | Goldberg 2016 [40] |
NSCLC | 18 | 6 (33.3%) | 1 (5.6%) | 2 (11.1%) | ||||||
Javelin Merkel 200 (NCT02155647) | 2 | Merkel cell carcinoma | Avelumab | 88 | 6 | 28 (31.8%) | Not reported | Not reported | 1 (1.1%) | Kaufman 2016 [41] |
Javelin Solid Tumor (NCT01772004) | 1b | Adrenocortical | Avelumab | 50 | 6 | 3 (6.0%) | 3 (6.0%) | Not reported | 1 (2.0%) | Le Tourneau [42] |
NSCLC | 184 | 22 (12.0%) | 22 (12.0%) | Not reported | 0 (0%) | Gulley 2017 [43] | ||||
Breast cancer | 168 | 5 (2.9%) | Not reported | Not reported | 2 (1.2%) | Dirix 2018 [44] | ||||
Ovarian cancer | 125 | 12 (9.6%) | 16 (12.8%) | Not reported | 7 (5.6%) | Disis 2019 [45] | ||||
UC | 161 | 27 (16.8%) | 28 (17.4%) | Not reported | 1 (0.6%) | Patel 2018 [46] | ||||
JAVELIN Solid Tumor JPN trial (NCT01943461) | 1 | Advanced solid tumors | Avelumab | 40 (dose- expansion cohort) | 6 | 4 (10.0%) | 4 (10.0%) | Not reported | Not reported | Doi 2019 [47] |
KEYNOTE-001 (NCT01295827) | 1 | NSCLC | Pembrolizumab | 550 | 12 | 121 (24.4%)c | 145 (26.4%) | Not reported | Not reported | |
Melanoma | 327 | Not reported | Not reported | Not reported | 24 (7.3%) | Hodi 2016 [9] | ||||
581 | 194 (33.4%) | 260 (44.8%) | Not reported | Not reported | Ribas 2016 [50] | |||||
KEYNOTE-002 (NCT01704287) | 2 | Melanoma | Pembrolizumab | 361 | 12 | 84 (23.3%) | Not reported | 72 (20.0%) | Not reported | Ribas 2015 [51] |
KEYNOTE-011 (NCT01840579) | 1 | Multiple tumor types | Pembrolizumab | 9 | 6 | 2 (22.2%) | 2 (22.2%) | 1 (11.1%) | 1 (11.1%) | Shimizu 2016 [52] |
KEYNOTE-012 (NCT01848834) | 1b | UC | Pembrolizumab | 27 | 8 | 7 (25.9%) | Not reported | Not reported | 0 (0.0%) | Plimack 2017 [53] |
HNSCC | 56 | 12 (21.4%) | Not reported | Not reported | 1 (1.8%) | Seiwert 2016 [54] | ||||
KEYNOTE-016 (NCT01876511) | 2 | CRC, MMR–deficient cancers | Pembrolizumab | 35 | 12 | 9 (25.7%) | 9 (25.7%) | Not reported | 0 (0.0%) | Le 2015 [55] |
KEYNOTE-224 (NCT02702414) | 2 | Hepatocellular carcinoma | Pembrolizumab | 104 | 9 | 18 (17.3%) | 18 (17.3%) | Not reported | Not reported | Zhu 2018 [56] |
NCI-2016-00545 (NCT02721732) | 2 | Multiple rare cancers | Pembrolizumab | 110 | 9 | Not reported | 15 (13.6%) | 34 (30.9%) | 6 (5.5%) | Naing 2020 [57] |
OAK (NCT02008227) | 3 | NSCLC | Atezolizumab | 425 | 6 | 58 (13.7%) | 68 (16.0%) | 168 (39.5%) | Not reported | |
ONO-4538-25 (NCT02582125) | 2 | NSCLC | Nivolumab | 53 | 6 | 5 (9.4%) | Not reported | 17 (32.1%) | Not reported | Chen 2020 [59] |
ONO-4538-07 (Not available) | 2 | Esophageal squamous-cell carcinoma | Nivolumab | 64 | 6 | 14 (21.9%) | 16 (25.0%) | Not reported | 2 (3.1%) | Kudo 2017 [60] |
NivoMes (NCT02497508) | 2 | Mesothelioma | Nivolumab | 34 | 6 | 9 (26.5%) | Not reported | Not reported | 3 (8.8%) | Quispel-Janssen 2018 [61] |
PCD4989g (NCT01375842) | 1 | Urothelial bladder cancer | Atezolizumab | 65 | 6 | 17 (26.2%) | Not reported | Not reported | 1 (1.5%) | Powles 2014 [62] |
RCC | 62 | 9 (14.5%) | Not reported | 28 (45.2%) | 6 (9.7%) | McDermott 2016 [63] | ||||
HNSCC | 32 | 7 (21.9%) | Not reported | 10 (31.3%) | Not reported | Colevas 2018 [64] | ||||
Breast | 115 | 11 (9.6%) | 15 (13.0%) | Not reported | 3 (2.6%) | Emens 2019 [65] | ||||
R2810-ONC-1540 (NCT02760498) | 2 | Cutaneous squamous cell carcinoma | Cemiplimab | 78 | 8 | 41 (52.6%) | Not reported | Not reported | 2 (2.6%) | Migden 2020 [66] |
SARC028 (NCT02301039) | 2 | Sarcoma | Pembrolizumab | 80 | 8 | 9 (11.3%) | 10 (12.5%) | Not reported | 3 (3.8%) | Tawbi 2017 [67] |
Umin 000005714 (Not available) | 2 | Ovarian cancer | Nivolumab | 20 | 8 | 3 (15.0%) | Not reported | Not reported | 1 (5.0%) | Hamanishi [68] |