Table 2. Reasonable dose/schedule details for recommended
regimens – Unresectable/Metastatic Disease
Regimen
(Recommendation #) Dosing Schedules (Source)
Ipilimumab plus
nivolumab followed by
nivolumab until disease
progression (3.1, 3.2)
Ipilimumab 3 mg/kg + nivolumab 1 mg/kg every 3 weeks for
4 doses, followed by nivolumab 3 mg/kg every 2 weeks, all by
intravenous infusion (Checkmate 067)
Ipilimumab 3 mg/kg + nivolumab 1 mg/kg every 3 weeks for 4
doses, followed by nivolumab 240 mg every 2 weeks or 480 mg
every 4 weeks all by intravenous infusion (FDA prescribing
information)
Nivolumab (3.1, 3.2) Nivolumab 3 mg/kg every 2 weeks by intravenous infusion
(Checkmate 067)
Nivolumab 240 mg every 2 weeks (US FDA Approved)
Nivolumab 480 mg every 4 weeks (US FDA Approved)
Pembrolizumab
(3.1, 3.2)
Pembrolizumab 10 mg/kg every 2 weeks or every 3 weeks by
intravenous infusion (Keynote 006)
Pembrolizumab 2 mg/kg every 3 weeks by intravenous infusion
(Keynote 002)
Pembrolizumab 200 mg every 3 weeks (US FDA approved)
Pembrolizumab 400 mg every 6 weeks (EU EMA approved
[based on Lala et al 2018])
Vemurafenib plus
cobimetinib (2.2)
Vemurafenib 960 mg orally twice daily without pause plus
cobimetinib 60 mg orally once daily in a cycle of 21 days with 7
days off. (CoBRIM)
Dabrafenib plus
trametinib (3.2)
Dabrafenib 150 mg orally twice daily plus trametinib 2 mg orally
once daily. (COMBI-v)
Encorafenib plus
binimetinib (3.2)
Encorafenib 450 mg orally once daily plus binimetinib 45 mg
orally twice daily (COLUMBUS)
NOTE: ese were doses/schedules considered reasonable at the time of publication of this
guideline. Additional doses and schedules may have been approved at the time of reading.