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A Phase 3 Randomized Study of Lenvatinib in Combination With Pembrolizumab Versus Standard of Care in Participants With Metastatic Colorectal Cancer Who Have Received and Progressed On or After or Became Intolerant to Prior Treatment
This trial has experimental and active comparator arms. In the Experimental arm, participants will receive pembrolizumab (400mg, intravenously) on Day 1 of each 6-week (Q6W) Cycle for up to 18 cycles (up to approximately 2 years) in combination with lenvatinib (200mg, orally) once daily until progressive disease. In the Active Comparator arm, participants will receive the standard of care treatment: regorafenib (160mg, orally) once daily on Days 1 through 21 of each 4-week cycle OR TAS-102 (trifluridine and tipiracil hydrochloride) (35mg/m^2, orally) twice a day on Days 1 through 5 and Days 8-12 of each 4-week cycle until progressive disease.