Active Ingredient: Nivolumab
Nivolumab in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the setting of first-line treatment of unresectable or metastatic colorectal cancer.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Intravenous, 240 milligrams nivolumab, once every 3 weeks, 4 doses in total, over the duration of 12 weeks. Afterwards, intravenous, 240 milligrams nivolumab, once every 2 weeks.
Regimen B: Intravenous, 240 milligrams nivolumab, once every 3 weeks, 4 doses in total, over the duration of 12 weeks. Afterwards, intravenous, 480 milligrams nivolumab, once every 4 weeks.
The recommended dose for first-line treatment of dMMR or MSI-H CRC is 240 mg of nivolumab in combination with 1 mg/kg ipilimumab administered intravenously every 3 weeks for a maximum of 4 doses, followed by nivolumab monotherapy administered intravenously at either 240 mg every 2 weeks or at 480 mg every 4 weeks. For the monotherapy phase, the first dose of nivolumab should be administered 3 weeks after the last dose of the combination of nivolumab and ipilimumab. Treatment with nivolumab is recommended until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
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