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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)

From: Treatment beyond progression with anti-PD-1/PD-L1 based regimens in advanced solid tumors: a systematic review

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 Garon 2015 [48], Garon 2019 [49]
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 Gandara 2018 [10], von Pawel 2019 [58]
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]
  1. Abbreviations: CRC colorectal cancer; HNSCC head and neck squamous cell carcinoma, MMR mismatch repair, NCT ClinicalTrials.gov Identifier, NSCLC non-small-cell lung carcinoma, ORR overall response rate, PD progressive disease, RCC renal-cell carcinoma, RT radiotherapy, SCLC small-cell lung carcinoma, UC urothelial cancer
  2. aadditional 12 patients achieved < 30% tumor reduction
  3. boverall, 25 patients achieved < 30% tumor reduction
  4. cbased on centrally-assessed RECIST 1.1 data reported by Garon et al. 2015 on 495 patients