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Study design: CheckMate 040 Cohort 4 (HCC)

  • Phase 1/2, dose-escalation, open-label study in patients with advanced HCC1
  • Primary endpoints: Safety and tolerability using NCI CTCAE v4.0, ORR and DOR by investigator assessmenta,1
  • Secondary endpoints: DCR, PFS, OS, TTP, TTR1
  • Other key endpoints: BOR and ORR based on BICR-assessed tumor responsea

The FDA indication is only for patients previously treated with sorafenib.
**Only Arm A has been approved by the FDA.

aUsing RECIST v1.1.
Figure adapted from Yau et al. 2020.1
2L+, second-line or later; BICR, blinded independent central review; BOR, best overall response; DCR, disease control rate; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group Performance Status; FDA, US Food and Drug Administration; HBV, hepatitis B virus; HCC, hepatocellular carcinoma; HCV, hepatitis C virus; IPI, ipilimumab; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; NIVO, nivolumab; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; QxW, every x weeks; R, randomization; RECIST, Response Evaluation Criteria in Solid Tumors; TTP, time to progression; TTR, time to response.
1. Yau T, et al. JAMA Oncol 2020;6:e204564.