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CheckMate 040

Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial

Phase 1/2N = 262NCT01658878

Population
Adults with advanced hepatocellular carcinoma with or without hepatitis C or B infection; 262 eligible patients treated (48 in dose escalation and 214 in dose expansion)
Design
Open-label, non-comparative dose-escalation (3+3 design, nivolumab 0.1-10 mg/kg every 2 weeks) and dose-expansion (nivolumab 3 mg/kg every 2 weeks in four cohorts) trial. Primary endpoints were safety and tolerability for the escalation phase and objective response rate (RECIST 1.1) for the expansion phase. Previous sorafenib was allowed.
Primary endpoint
ORR
Arms
  • Dose escalation (experimental, n = 48): Nivolumab 0.1-10 mg/kg every 2 weeks
  • Dose expansion (experimental, n = 214): Nivolumab 3 mg/kg every 2 weeks
People
El-Khoueiry AB
Show the numbers
Results reported for CheckMate 040
EndpointAnalysisDose escalation / Dose expansionControlEffect
ORRTreated patients in each phase (abstract does not state ITT)primaryEl-Khoueiry 201715% (6–28%)—Objective response rate in patients treated with nivolumab 3 mg/kg in the dose-expansion phase (20%) and in the dose-escalation phase (15%). The abstract does not give the response rate of the sorafenib-progressor cohort; the full text reports 12 of 57 (21%) responses in the cohort of sorafenib progressors without viral hepatitis (one of four expansion cohorts).
Results reported for CheckMate 040
EndpointAnalysisDose escalation / Dose expansionControlEffect
ORRTreated patients in each phase (abstract does not state ITT)primaryEl-Khoueiry 201715% (6–28%)—Objective response rate in patients treated with nivolumab 3 mg/kg in the dose-expansion phase (20%) and in the dose-escalation phase (15%). The abstract does not give the response rate of the sorafenib-progressor cohort; the full text reports 12 of 57 (21%) responses in the cohort of sorafenib progressors without viral hepatitis (one of four expansion cohorts).
Primary publication: El-Khoueiry AB, Sangro B, Yau T, Crocenzi TS, Kudo M, Hsu C, et al. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017;389(10088):2492-2502. PubMedDOI

Appears in

Sources

  1. El-Khoueiry AB, Sangro B, Yau T, Crocenzi TS, Kudo M, Hsu C, et al. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017;389(10088):2492-2502.

    PubMedDOI