BMS needs to find the proper dosing for Ipi+Nivo in solid tumors.
The efficacy, I am certain, is going to be very eye opening in RCC and NSCLC when they are announced. BMS just needs to drill down on ipilum dosing levels and schedule
....which is what Checkmate 012 on clinicaltrials.gov is for.
Experimental: Arm G: Nivolumab + Ipilimumab
In Squamous histology subjects (NSCLC)
Nivolumab 1 mg/kg solution administered over 60 minutes intravenously prior to Ipilimumab on Day 1 of each cycle. A cycle is 3 weeks for combination regimen. Combination regimen will be provided for 4 cycles.
Ipilimumab 3 mg/kg solution administered over 90 minutes intravenously on Day 1 of each cycle, every 3 weeks for 4 cycles.
Followed by Nivolumab (3 mg/kg) administered every 2 weeks until PD or discontinuation due to toxicity.
Biological: Nivolumab
Other Name: BMS-936558
Biological: Ipilimumab
Experimental: Arm H: Nivolumab + Ipilimumab
In non-squamous histology subjects (NSCLC)
Nivolumab 1 mg/kg solution administered over 60 minutes intravenously prior to Ipilimumab on Day 1 of each cycle. A cycle is 3 weeks for combination regimen. Combination regimen will be provided for 4 cycles.
Ipilimumab 3 mg/kg solution administered over 90 minutes intravenously on Day 1 of each cycle, every 3 weeks for 4 cycles.
Followed by Nivolumab (3 mg/kg) administered every 2 weeks until PD or discontinuation due to toxicity.
Biological: Nivolumab
Other Name: BMS-936558
Biological: Ipilimumab
Experimental: Arm I: Nivolumab + Ipilimumab
In squamous histology subjects (NSCLC)
Nivolumab 3 mg/kg solution administered over 60 minutes intravenously prior to Ipilimumab on Day 1 of each cycle. A cycle is 3 weeks for combination regimen. Combination regimen will be provided for 4 cycles.
Ipilimumab 1 mg/kg solution administered over 90 minutes intravenously on Day 1 of each cycle, every 3 weeks for 4 cycles.
Followed by Nivolumab (3 mg/kg) administered every 2 weeks until PD or discontinuation due to toxicity.
Biological: Nivolumab
Other Name: BMS-936558
Biological: Ipilimumab
Experimental: Arm J: Nivolumab + Ipilimumab
In non-squamous histology subjects (NSCLC)
Nivolumab 3 mg/kg solution administered over 60 minutes intravenously prior to Ipilimumab on Day 1 of each cycle. A cycle is 3 weeks for combination regimen. Combination regimen will be provided for 4 cycles.
Ipilimumab 1 mg/kg solution administered over 90 minutes intravenously on Day 1 of each cycle, every 3 weeks for 4 cycles.
Followed by Nivolumab (3 mg/kg) administered every 2 weeks until PD or discontinuation due to toxicity.
AI
