A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (KEYFORM-007)
A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (KEYFORM-007)
The purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil).
The primary study hypothesis is that coformulated favezelimab/pembrolizumab (MK-4280A) is superior to standard of care with respect to overall survival.
Inclusion Criteria:
Exclusion Criteria:
Washington D.C., District of Columbia 20007, United States
Marietta, Georgia 30060, United States
Toronto, Ontario M5G 2M9, Canada
Guangzhou, Guangdong 510655, China
Wuxi, Jiangsu 214122, China
Tianjin, Tianjin Municipality 300060, China
Roma, Abruzzo 00168, Italy
Naples, 80131, Italy
Kita-gun, Kagawa-ken 761-0793, Japan
Kitaadachi-gun, Saitama 362-0806, Japan
Sunto-gun,, Shizuoka 411-8777, Japan
Loerenskog, Akershus 1478, Norway
Bergen, Vestfold 5053, Norway
Ufa, Baskortostan, Respublika 450054, Russia
Kirov, Kirov Oblast 105094, Russia
Moscow, Moscow 115682, Russia
Saint Petersburg, Sankt-Peterburg 197758, Russia
Tomsk, Tomsk Oblast 634045, Russia
Yaroslavl, Yaroslavl Oblast 150054, Russia
Saint Petersburg, 188663, Russia
Port Elizabeth, Eastern Cape 6045, South Africa
Songpagu, Seoul 05505, South Korea
Adana, 01120, Turkey (Türkiye)
Dnipro, Dnipropetrovsk Oblast 49102, Ukraine
Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018, Ukraine
London, Camden WC1E 6AG, United Kingdom
London, London, City of W12 0HS, United Kingdom
Coventry, Warwickshire CV2 2DX, United Kingdom