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Study designs


CheckMate 8HW (Phase 3)1

  • Phase 3 randomised, multicentre, open-label study in patients with unresectable or metastatic CRCa,1
  • Primary endpoints: PFS by BICR (NIVO + IPI vs chemo in 1L; NIVO + IPI vs NIVO across all lines)1
  • Secondary endpoints: PFS by BICR, ORR by BICR (NIVO + IPI vs NIVO in 1L for both endpoints)1
  • Other key endpoints: Safety1
aClinicalTrials.gov. NTC04008030.1
bPatients with >2 prior lines are randomised only to the NIVO or NIVO + IPI arms.1
cPatients can continue NIVO treatment upon early IPI discontinuation.1
dPatients receiving investigator’s choice of chemo are eligible to receive NIVO + IPI upon progression (crossover treatment).1

CheckMate 142 (Phase 1/2)2

  • Phase 2 multi-cohort study in patients with recurrent/metastatic CRC2
  • Primary endpoint: ORR per investigator assessment (RECIST v1.1)a,2
  • Secondary endpoint: ORR per BICRa,2
  • Other key endpoints: DCR, DOR, PFS, OS, and safetya,2

aTumor imaging assessments were performed every 6 weeks for 24 weeks and thereafter every 12 weeks until disease progression or discontinuation.2
Figure adapted from Overman et al. 2018.2

1L, first line; BICR, blinded independent central review; BID, twice a day; BOR, best overall response; CRC, colorectal cancer; DCR, disease control rate; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group Performance Status; HBV, hepatitis B virus; HCC, hepatocellular carcinoma; HCV, hepatitis C virus; HRQoL, health-related quality of life; IPI, ipilimumab; LRT, locoregional therapy; MSI-H/dMMR, microsatellite instability-high/mismatch repair deficient; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; NIVO, nivolumab; ORR, overall response rate; OS, overall survival; PD-L1, programmed death-ligand 1; PFS, progression-free survival; PO, oral administration; QD, once a day; QxW, every x weeks; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1; TTD, time to deterioration; TTP, time to progression; TTR, time to response.

1. André T, et al. N Engl J Med 2024;391:2014-2026.

2. Overman MJ, et al. J Clin Oncol 2018;36:773-779.