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Study design: CheckMate 743 (unresectable malignant pleural mesothelioma)

  • Phase 3, randomized, open-label trial in patients with unresectable malignant pleural mesothelioma1
  • Primary endpoint: OS1
  • Secondary endpoints: ORR, DCR, and PFS by BICR, PD-L1a expression as a predictive biomarker1

*Although NIVO 3 mg/kg Q2W is used in CheckMate 743, NIVO 360 mg Q3W is the regimen approved by the FDA. Flat dose approval is based on pharmacokinetic modeling and clinical subgroup efficacy and safety analyses. The benefits/risk of NIVO 360 mg Q3W is expected to be similar to that of NIVO 3 mg/kg Q2W.

aDetermined by PD-L1 IHC 28-8 pharmDx assay from Dako. bCisplatin (75 mg/m2) or carboplatin (AUC 5) + pemetrexed (500 mg/m2), Q3W for 6 cycles. Figure adapted from Baas et al. 2021.1

AUC, area under the curve; BICR, blinded independent central review; DCR, disease control rate; ECOG PS, Eastern Clinical Oncology Group Performance Status; FDA, US Food and Drug Administration; IHC, immunohistochemistry; IPI, ipilimumab; NIVO, nivolumab; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PD-L1, programmed death ligand 1; QxW, every x weeks; R, randomization.
1. Baas PB, et al. Lancet 2021;397:375–386.