TriangleHEALTH PROFESSIONAL · SOURCE READING
Nivolumab and ipilimumab
Source: Primary Liver Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: April 17, 2025 · Captured 2026-09-09.
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Evidence (nivolumab and ipilimumab):
Cohort 4 of CheckMate 040 (NCT01658878), a multicenter, open-label, phase I/II study, enrolled 148 patients with advanced HCC and Child-Pugh class A liver function previously treated with sorafenib. Patients were randomly assigned in a 1:1:1 ratio to one of the following three dosages:[26]
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Cohort 4 of CheckMate 040 (NCT01658878), a multicenter, open-label, phase I/II study, enrolled 148 patients with advanced HCC and Child-Pugh class A liver function previously treated with sorafenib. Patients were randomly assigned in a 1:1:1 ratio to one of the following three dosages:[26]
Arm A: Nivolumab 1 mg/kg with ipilimumab 3 mg/kg every 3 weeks for 4 doses, followed by maintenance nivolumab 240 mg every 2 weeks.
Cohort 4 of CheckMate 040 (NCT01658878), a multicenter, open-label, phase I/II study, enrolled 148 patients with advanced HCC and Child-Pugh class A liver function previously treated with sorafenib. Patients were randomly assigned in a 1:1:1 ratio to one of the following three dosages:[26]
Arm B: Nivolumab 3 mg/kg with ipilimumab 1 mg/kg every 3 weeks for 4 doses, followed by maintenance nivolumab 240 mg every 2 weeks.
Cohort 4 of CheckMate 040 (NCT01658878), a multicenter, open-label, phase I/II study, enrolled 148 patients with advanced HCC and Child-Pugh class A liver function previously treated with sorafenib. Patients were randomly assigned in a 1:1:1 ratio to one of the following three dosages:[26]
Arm C: Nivolumab 3 mg/kg every 2 weeks with ipilimumab 1 mg/kg every 6 weeks.
Cohort 4 of CheckMate 040 (NCT01658878), a multicenter, open-label, phase I/II study, enrolled 148 patients with advanced HCC and Child-Pugh class A liver function previously treated with sorafenib. Patients were randomly assigned in a 1:1:1 ratio to one of the following three dosages:[26]
The median OS was 22.8 months (95% CI, 9.4–not reached) in arm A, 12.5 months (95% CI, 7.6–16.4) in arm B, and 12.7 months (95% CI, 7.4–33.0) in arm C.[26][Level of evidence A1]
Source links and citations
Cohort 4 of CheckMate 040 (NCT01658878), a multicenter, open-label, phase I/II study, enrolled 148 patients with advanced HCC and Child-Pugh class A liver function previously treated with sorafenib. Patients were randomly assigned in a 1:1:1 ratio to one of the following three dosages:[26]
The objective response rates were 32% (95% CI, 20%–47%) in arm A, 27% (95% CI, 15%–41%) in arm B, and 29% (95% CI, 17%–43%) in arm C.
Cohort 4 of CheckMate 040 (NCT01658878), a multicenter, open-label, phase I/II study, enrolled 148 patients with advanced HCC and Child-Pugh class A liver function previously treated with sorafenib. Patients were randomly assigned in a 1:1:1 ratio to one of the following three dosages:[26]
Grade 3 or higher treatment-related adverse events occurred in 76% of patients in arm A, 65% of patients in arm B, and 69% of patients in arm C.
Based on these data, the FDA granted accelerated approval for nivolumab (1 mg/kg IV) with ipilimumab (3 mg/kg IV every 3 weeks for 4 doses), followed by nivolumab (240 mg IV every 2 weeks) for patients with advanced HCC previously treated with sorafenib.[27]
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Preserved source evidence · Not medical advice