Table 3 Successfully finished phase 3 clinical trials of immune checkpoint inhibitor drugs among diverse cancer types
From: Immune checkpoint therapy for solid tumours: clinical dilemmas and future trends
Disease | Code | NCT number | Enrolment | Arms | Follow-up | Median PFS/RFS | Median OS | PMID |
|---|---|---|---|---|---|---|---|---|
Untreated unresectable stage III or IV melanoma | — | NCT00324155 | 681 | A: Ipilimumab 10 mg/kg (Q3W, −22 weeks) + Dacarbazine 850 mg/m^2 (Q3W, −22 weeks) B: Dacarbazine 850 mg/m^2 (Q3W, −22 weeks) | 5-year | – | A: 11.2 months B: 9.1 months | 25713437 |
Complete resection of high-risk stage III melanoma | EORTC-18071 | NCT00636168 | 1211 | A: Ipilimumab 10 mg/kg (Q3W, −3 years) B: Placebo | 5-year | A: 27.6 months B: 17.1 months | — | 27717298 |
Unresectable or metastatic melanoma | — | NCT01515189 | 831 | A: Ipilimumab 10 mg/kg (Q3W, 4 doses) B: Ipilimumab 3 mg/kg (Q3W, 4 doses) | 5-year | — | A: 15.7 months B: 11.5 months | 32503946 |
Untreated, unresectable, or metastatic melanoma | CheckMate-066 | NCT01721772 | 418 | A: Nivolumab 3 mg/kg B: Dacarbazine 1000 mg/m^2 | 5-year | A: 5.1 months B: 2.2 months | A: 34.8 months B: 20.5 months | 32997575 |
Unresectable or metastatic melanoma | KEYNOTE-006 | NCT01866319 | 834 | A: Pembrolizumab 10 mg/kg (Q2W, −24 months) B: Pembrolizumab 10 mg/kg (Q3W, −24 months) C: Ipilimumab 3 mg/kg (Q3W, 4 doses) | 5-year | A + B: 8.4 months C: 3.4 months | A + B: 32.7 months C: 15.9 months | 31345627 |
Previously treated advanced or metastatic squamous cell NSCLC | CheckMate-017 CheckMate-057 | NCT01642004 NCT01673867 | 854 | A: Nivolumab 3 mg/kg or 480 mg B: Docetaxel | 5-year | — | A: 11.1 months B: 8.1 months | 33449799 |
Previously treated NSCLC | KEYNOTE-010 | NCT01905657 | 1034 | A: Pembrolizumab 2 mg/kg (Q3W, −2 years) B: Pembrolizumab 10 mg/kg (Q3W, −2 years) C: Docetaxel 75 mg/m^2 | 5-year | — | A + B: 11.8 months C: 8.4 months | 34048946 |
Previously untreated stage IV, programmed cell death ligand 1 (PD-L1) strong expressing NSCLC | KEYNOTE-024 | NCT02142738 | 305 | A: Pembrolizumab 200 mg (Q3W, −35 doses) B: Chemotherapy | 5-year | A: 7.7 months B: 5.5 months | A: 26.3 months B: 13.4 months | 33872070 |
PD-L1 strong expressing NSCLC | KEYNOTE-042 | NCT02220894 | 1274 | A: Pembrolizumab 200 mg (Q3W, −35 doses) B: Chemotherapy | 5-year | — | A: 16.4 months B: 12.1 months | 36306479 |
Locally advanced or metastatic NSCLC | OAK | NCT02008227 | 1225 | A: Atezolizumab 1200 mg B: Docetaxel 75 mg/m^2 | 2.25 years | — | A: 13.8 months B: 9.6 months | 27979383 |
Stage IV non-squamous NSCLC | Impower-130 | NCT02367781 | 723 | A: Atezolizumab+Nab-Paclitaxel+Carboplatin B: Nab-Paclitaxel+Carboplatin | Median 18.5 months | A: 7.0 months B: 5.5 months | A: 18.6 months B: 13.9 months | 31122901 |
PD-L1-selected, chemotherapy-naive stage IV NSCLC | Impower-110 | NCT02409342 | 572 | A: Atezolizumab B: Chemotherapy | Median 15.7 months | A: 7.2 months B: 5.5 months | A: 20.2 months B: 13.1 months | 32997907 |
Extensive-disease small cell lung cancer | Impower-133 | NCT02763579 | 403 | A: Atezolizumab 1200 mg + EP B: Placebo + EP | Median 22.9 months | — | A: 12.3 months B: 10.3 months | 31959349 |
CASPIAN | NCT03043872 | 987 | A: Durvalumab+Tremelimumab+EP B: Durvalumab+EP C: EP | Median 25.1 months | — | B: 12.9 months C: 10.5 months | 33285097 | |
ASTRUM-005 | NCT04063163 | 585 | A: Serplulimab + EP B: Placebo + EP | Median 12.3 months | A: 5.7 months B: 4.3 months | A: 15.4 months B: 10.9 months | 36166026 | |
Advanced or metastatic (medically or surgically unresectable) clear-cell renal cell carcinoma | CheckMate-025 | NCT01668784 | 821 | A: Nivolumab 3 mg/kg B: Everolimus | 5-year | — | A: 25.8 months B: 19.7 months | 32673417 |
Metastatic or locally advanced/unresectable urothelial carcinoma | KEYNOTE-045 | NCT02256436 | 542 | A: Pembrolizumab 200 mg (Q3W, −35 doses) B: Chemotherapy | Median 27.7 months | — | A: 10.1 months B: 7.3 months | 31050707 |
Locally advanced or metastatic urothelial bladder carcinoma | IMvigor-211 | NCT02302807 | 931 | A: Atezolizumab B: Chemotherapy | Median 33 months | — | A: 8.6 months B: 8.0 months | 33902955 |
Advanced renal cell carcinoma | CLEAR | NCT02811861 | 1069 | A: Lenvatinib 20 mg + Pembrolizumab 200 mg B: Sunitinib 50 mg | Median 26.6 months | A: 23.9 months B: 9.2 months | — | 33616314 |
Unresectable advanced or recurrent esophageal cancer | ATTRACTION-3 | NCT02569242 | 419 | A: Nivolumab 240 mg B: Docetaxel/Paclitaxel | Minimum 17.6 months | — | A: 10.9 months B: 8.4 months | 31582355 |
Advanced/metastatic adenocarcinoma and squamous cell carcinoma of the esophagus that have progressed after first-line standard therapy | KEYNOTE-181 | NCT02564263 | 628 | A: Pembrolizumab 200 mg (Q3W, −2 years) B: Chemotherapy | 16 months | — | A: 9.3 months B: 6.7 months | 33026938 |
Stage IV mismatched repair deficient or microsatellite instability-high colorectal carcinoma | KEYNOTE-177 | NCT02563002 | 307 | A: Pembrolizumab 200 mg (Q3W, −35 doses) B: Chemotherapy | 44.5 months | A: 16.5 months B: 8.2 months | No significant difference | 35427471 |
Recurrent or metastatic head and neck squamous cell cancer | CheckMate-141 | NCT02105636 | 361 | A: Nivolumab 3 mg/kg B: Cetuximab/Methotrexate/Docetaxel | 1-year | — | A: 7.5 months B: 5.1 months | 27718784 |
KEYNOTE-040 | NCT02252042 | 495 | A: Pembrolizumab 200 mg (Q3W, −2 years) B: Cetuximab/Methotrexate/Docetaxel | 2-year | — | A: 8.4 months B: 6.9 months | 30509740 | |
KEYNOTE-048 | NCT02358031 | 882 | A: Pembrolizumab 200 mg (Q3W, −2 years) B: Pembrolizumab 200 mg (Q3W, −2 years) + Chemotherapy C: Cetuximab + Chemotherapy | Median 45 months | — | A: 14.9 months B: 14.7 months C: 10.8 months | 36219809 | |
Squamous cell carcinoma Recurrent or metastatic, platinum-refractory cervical cancer | EMPOWER | NCT03257267 | 608 | A: Cemiplimab 350 mg B: Chemotherapy | Median 18.2 months | — | A: 12.0 months B: 8.5 months | 35139273 |
Persistent, recurrent, or metastatic cervical cancer | KEYNOTE-826 | NCT03635567 | 617 | A: Pembrolizumab 200 mg (Q3W, −2 years) + Chemotherapy B: Placebo+Chemotherapy | Median 22 months | A: 10.4 months B: 8.2 months | A: 53.0–54.4% B: 41.7–44.6% | 34534429 |
Previously untreated metastatic triple-negative breast cancer | Impassion130 | NCT02425891 | 902 | A: Atezolizumab + Nab-Paclitaxel B: Placebo + Nab-Paclitaxel | Median 18.8 months | — | A: 25.4 months B: 17.9 months (PD-L1 positive) | 34272041 |
Previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer | KEYNOTE-355 | NCT02819518 | 882 | A: Pembrolizumab 200 mg (Q3W, −2 years) + Chemotherapy B: Placebo + Chemotherapy | Median 44.1 months | — | A: 23.0 months B: 16.1 months | 35857659 |
Triple-negative breast cancer | KEYNOTE-522 | NCT03036488 | 1174 | A: Pembrolizumab 200 mg (Q3W, −2 years)+ Chemotherapy B: Placebo + Chemotherapy | Median 39.1 months | A: 84.5% B: 76.8% | — | 35139274 |
