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Table 7 Landmark clinical trials in the development of CTLA-4 and PD-1/PD-L1 inhibitors

From: Clinical development of targeted and immune based anti-cancer therapies

CTLA-4 inhibitors
 Ipilimumab (Yervoy®)
  Drug Name Clinical Trial ID Trial Name Population Comparator Year Sponsor Phase N Median OS (months) Median PFS (months)
CTLA-4 inhibitors
 Ipilimumab (Yervoy®)
  Ipilimumab (3 mg/kg/3w) NCT00094653 MDX010–020 Melanoma Gp100 vaccine 2004–2011 Bristol-Myers Squibb III 1783 10.0 vs 6.4 2.9 vs 2.8
  Ipilimumab (10 mg/kg/3w) NCT00636168   Melanoma Placebo 2008–2013 Bristol-Myers Squibb III 1211 93.5 vs 87.7 63.5 vs 56.1
 Ipilimumab (3 mg/kg/3w) NCT01696045   Melanoma None 2012–2016 Bristol-Myers Squibb II 14 18.2 2.6
  Ipilimumab (1 mg/kg/3w) + nivolumab NCT02231749 CHECKMATE-214 RCC Sunitinib 2014–2017 Bristol-Myers Squibb III 1390 NA vs 26.0 11.6 vs 8.4
  Ipilimumab (1 mg/kg/3w) NCT02060188 CHECKMATE-142 CRC Chemotherapy 2014–2018 Bristol-Myers Squibb II 340 NR NR
  Ipilimumab (1 mg/kg/ 6w) + nivolumab NCT03083691 BIOLUMA NSCLC, SCLC Nivolumab 2017–2019 Bristol-Myers Squibb II 106 NR NR
  Ipilimumab (10 mg/kg/3mo) + bevacizumab NCT00790010   Melanoma None 2009–2018 Bristol-Myers Squibb I 46 NR NR
  Ipilimumab (10 mg/kg/3mo) NCT01119508   Melanoma None 2010–2016 Bristol-Myers Squibb II 64 NR NR
PD-1/PD-1 L inhibitors
 Pembrolizumab (Keytruda®)
  Pembrolizumab (2-10 mg/kg/3w) NCT01295827 KEYNOTE-001 Melanoma, NSCLC None 2011–2018 Merck Sharp & Dohme Corp. I 1260 12.0 3.7
  Pembrolizumab (2 mg/kg/3w) NCT01704287 KEYNOTE-002 Melanoma Chemotherapy 2012–2015 Merck Sharp & Dohme Corp. II 540 13.4 vs 11.0 2.9 vs 2.8
  Pembrolizumab (10 mg/kg/2w) NCT01866319 KEYNOTE-006 Melanoma Ipilimumab 2013–2015 Merck Sharp & Dohme Corp. III 834 74.1 vs 58.2% 5.5 vs 2.8
  Pembrolizumab (10 mg/kg/2w) NCT01848834 KEYNOTE-012 Head and Neck SCC None 2013–2016 Merck Sharp & Dohme Corp. I 297 59% 23%
  Pembrolizumab (200 mg/3w) NCT02142738 KEYNOTE-024 NSCLC BSC 2014–2016 Merck Sharp & Dohme Corp. III 305 80.2 vs 72.4% 62.1 vs 50.3%
  Pembrolizumab (200 mg/3w) NCT02453594 KEYNOTE-087 Hodgkin Lymphoma None 2015–2021 Merck Sharp & Dohme Corp. II 211 97.5% 63.4%
  Pembrolizumab (200 mg/3w) + chemotherapy NCT02039674 KEYNOTE-021 NSCLC Chemotherapy 2014–2016 Merck Sharp & Dohme Corp. I/II 267 NR 13.0 vs 8.9
  Pembrolizumab (200 mg/3w) NCT02335424 KEYNOTE-052 Urothelial cancer None 2015–2018 Merck Sharp & Dohme Corp. II 374 67% 30%
  Pembrolizumab (10 mg/kg/2w) NCT01876511 KEYNOTE-016 CRC (MSI) None 2013–2021 Merck Sharp & Dohme Corp. II 171 76% 64%
  Pembrolizumab (200 mg/3w) NCT02460198 KEYNOTE-164 CRC None 2015–2019 Merck Sharp & Dohme Corp. II 124 NR NR
  Pembrolizumab (10 mg/kg/2w) NCT02054806 KEYNOTE-028 Solid tumors None 2014–2019 Merck Sharp & Dohme Corp. I 477 62.6% 20.8%
  Pembrolizumab (200 mg/3w) NCT02628067 KEYNOTE-158 Solid tumors None 2015–2023 Merck Sharp & Dohme Corp. II 1350 NR NR
  Pembrolizumab (200 mg/3w) NCT02335411 KEYNOTE-059 Gastric and gastroesophageal junction adenocarcinomas None 2015–2019 Merck Sharp & Dohme Corp. II 316 5.6 2.0
  Pembrolizumab (200 mg/3w) NCT02576990 KEYNOTE-170 Large B-cell lymphoma None 2015–2019 Merck Sharp & Dohme Corp. II 80 NR NR
  Pembrolizumab (200 mg/3w) NCT02578680 KEYNOTE-189 NSCLC Placebo 2016–2017 Merck Sharp & Dohme Corp. III 646 69.2 vs 49.4% 8.8 vs 4.9
 Nivolumab (Opdivo®)
  Nivolumab (3 mg/kg/2w) NCT01721746 CHECKMATE-037 Melanoma Chemotherapy 2012–2016 Bristol-Myers Squibb III 631 15.7 vs 14.4 3.1 vs 3.7
  Nivolumab (3 mg/kg/2w) NCT01642004 CHECKMATE-017 NSCLC Docetaxel 2012–2014 Bristol-Myers Squibb III 352 9.2 vs 6.0 20.8 vs 6.4
  Nivolumab (3 mg/kg/2w) NCT01673867 CHECKMATE-057 NSCLC Docetaxel 2012–2015 Bristol-Myers Squibb III 792 12.2 vs 9.4 2.3 vs 4.2
  Nivolumab (3 mg/kg/2w) NCT01668784 CHECKMATE-025 RCC Everolimus 2012–2015 Bristol-Myers Squibb III 1068 25.0 vs 19.6 4.6 vs 4.4
  Nivolumab (3 mg/kg/2w) NCT02181738 CHECKMATE-205 Hodgkin Lymphoma None 2014–2017 Bristol-Myers Squibb II 338 98·7% 10.0
  Nivolumab (3 mg/kg/2w) NCT01592370 CHECKMATE-039 Hodgkin’s Lymphoma, None 2012–2020 Bristol-Myers Squibb I/II 375 NR NR
  Nivolumab (3 mg/kg/2w) NCT02105636 CHECKMATE-141 Head and Neck SCC Chemotherapy 2014–2015 Bristol-Myers Squibb III 506 36.0 vs 16.6 NR
  Nivolumab (3 mg/kg/2w) NCT02387996 CHECKMATE-275 Advanced cancer None 2015–2016 Bristol-Myers Squibb II 386 8.7 2.0
  Nivolumab (3 mg/kg/2w) NCT02060188 CHECKMATE-142 CRC None 2014–2018 Bristol-Myers Squibb II 340 73% 14.3
  Nivolumab (3 mg/kg/2w) NCT01928394 CHECKMATE-032 Advanced solid tumors None 2013–2018 Bristol-Myers Squibb I/II 1150 9.7 16.2
  Nivolumab (3 mg/kg/2w) NCT01658878 CHECKMATE-040 HCC None 2012–2019 Bristol-Myers Squibb I/II 620 10.7 4.0
  Nivolumab (1 mg/kg/3w) + ipilimumab (3 mg/kg/3w) NCT01844505 CHECKMATE-067 Melanoma Ipilimumab + placebo 2013–2016 Bristol-Myers Squibb III 1296 63.8 vs 53.6% 6.9 vs 2.9
 Atezolizumab (Tecentriq®)
  Atezolizumab (1200 mg/3w) NCT02108652 IMVigor 210 Urothelial cancer None 2014–2015 Hoffmann-La Roche II 310 7.9 2.1
  Atezolizumab (1200 mg/3w) NCT01903993 POPLAR NSCLC Docetaxel 2013–2015 Hoffmann-La Roche II 287 12.6 vs 9.7 2.7 vs 3.4
  Atezolizumab (1200 mg/3w) NCT02008227 OAK NSCLC Docetaxel 2014–2016 Hoffmann-La Roche III 1225 13.8 vs 9.6 2.8 vs 4.0
 Durvalumab (Imfinzi®)
  Durvalumab (10 mg/kg/2w) NCT01693562 Study 1108 Advanced solid tumors None 2012–2019 MedImmune LLC I/II 1022 1.5 18.2
  Durvalumab (10 mg/kg/2w) NCT02516241 DANUBE Urothelial cancer None 2015–2019 AstraZeneca III 1200 NR NR
  Durvalumab (10 mg/kg/2w) NCT02125461 PACIFIC NSCLC Placebo 2014–2017 AstraZeneca III 713 NR 16.8 vs 5.6
 Avelumab (Bavencio®)
  Avelumab (10 mg/kg/2w) NCT02155647 JAVELIN Merkel 200 Merkel Cell Carcinoma None 2014–2019 EMD Serono II 204 11.3 2.0
  Avelumab (10 mg/kg/2w) NCT01772004 JAVELIN Solid Tumor Advanced solid tumors None 2013–2018 EMD Serono I 1758 13.7 2.7