Name | Type | Description | Interventions |
---|
Arm A: Nivolumab + Gemcitabine + Cisplatin | Experimental | Nivolumab solution intravenously every 3 weeks until progressive disease (PD) or discontinuation due to toxicity. Administered prior to chemotherapy on Day 1 of each cycle
Gemcitabine solution intravenously on Day 1 and Day 8 of every cycle for 4 cycles
Cisplatin solution intravenously on Day 1 of each cycle for 4 cycles | - Nivolumab
- Gemcitabine
- Cisplatin
|
Arm B: Nivolumab + Pemetrexed + Cisplatin | Experimental | Nivolumab solution intravenously every 3 weeks until PD or discontinuation due to toxicity. Administered prior to chemotherapy on Day 1 of each cycle
Pemetrexed solution intravenously on Day 1 of every cycle for 4 cycles
Cisplatin solution intravenously on Day 1 of each cycle for 4 cycles | - Nivolumab
- Cisplatin
- Pemetrexed
|
Arm C: Nivolumab + Paclitaxel + Carboplatin | Experimental | Nivolumab solution intravenously every 3 weeks until PD or discontinuation due to toxicity. Administered prior to chemotherapy on Day 1 of each cycle
Paclitaxel solution intravenously on Day 1 of every cycle for 4 cycles
Carboplatin area under curve (AUC) 6 solution intravenously on Day 1 of every cycle for 4 cycles | - Nivolumab
- Paclitaxel
- Carboplatin
|
Arm D: Nivolumab + Bevacizumab maintenance | Experimental | Nivolumab solution intravenously every 3 weeks until PD or discontinuation due to toxicity. Administered prior to chemotherapy on Day 1 of each cycle
Bevacizumab administered prior to intravenous infusion on Cycle 1 Day 1 followed by intravenous infusion every 3 weeks on Cycle 2 onwards and until PD or discontinuation due to toxicity | |
Arm E: Nivolumab + Erlotinib | Experimental | Nivolumab solution intravenously every 2 weeks until PD or discontinuation due to toxicity. Administered prior to chemotherapy on Day 1 of each cycle
Erlotinib tablet by mouth daily until PD or discontinuation due to toxicity | |
Arm F: Nivolumab | Experimental | Nivolumab solution intravenously every 2 weeks until PD or discontinuation due to toxicity. Administered over 60 minutes | |
Arm G: Nivolumab + Ipilimumab | Experimental | In Squamous histology subjects (NSCLC)
Nivolumab solution administered intravenously prior to Ipilimumab on Day 1 of each cycle. Combination regimen will be provided for 4 cycles
Ipilimumab solution administered intravenously on Day 1 of each cycle, for 4 cycles
Followed by Nivolumab administered until PD or discontinuation due to toxicity | |
Arm H: Nivolumab + Ipilimumab | Experimental | In non-squamous histology subjects (NSCLC)
Nivolumab solution administered intravenously prior to Ipilimumab on Day 1 of each cycle. Combination regimen will be provided for 4 cycles
Ipilimumab solution administered intravenously on Day 1 of each cycle, for 4 cycles
Followed by Nivolumab administered every 2 weeks until PD or discontinuation due to toxicity | |
Arm I: Nivolumab + Ipilimumab | Experimental | In squamous histology subjects (NSCLC)
Nivolumab solution administered intravenously prior to Ipilimumab on Day 1 of each cycle. Combination regimen will be provided for 4 cycles
Ipilimumab solution administered intravenously on Day 1 of each cycle, for 4 cycles
Followed by Nivolumab administered every 2 weeks until PD or discontinuation due to toxicity | |
Arm J: Nivolumab + Ipilimumab | Experimental | In non-squamous histology subjects (NSCLC)
Nivolumab solution administered intravenously prior to Ipilimumab on Day 1 of each cycle. Combination regimen will be provided for 4 cycles
Ipilimumab solution administered intravenously on Day 1 of each cycle, for 4 cycles
Followed by Nivolumab administered every 2 weeks until PD or discontinuation due to toxicity | |
Arm K: Nivolumab | Experimental | In squamous histology subjects (NSCLC)
Nivolumab solution intravenously every 2 weeks until PD or discontinuation due to toxicity. Administered as switch maintenance therapy. A cycle is 2 weeks | |
Arm L: Nivolumab | Experimental | In non-squamous histology subjects (NSCLC)
Nivolumab solution intravenously every 2 weeks until PD or discontinuation due to toxicity. Administered over 60 minutes as switch maintenance therapy. A cycle is 2 weeks | |
Arm M: Nivolumab | Experimental | NSCLC subjects with untreated, asymptomatic brain metastases and have no evidence of cerebral edema
Nivolumab solution intravenously every 2 weeks until PD or discontinuation due to toxicity. Administered for up to an hour as monotherapy. A cycle is 2 weeks | |
Arm N: Nivolumab + Ipilimumab | Experimental | In subjects with any histology (NSCLC)
Nivolumab solution administered intravenously prior to Ipilimumab on Day 1 of each cycle. Combination regimen will be provided for 4 cycles
Ipilimumab solution administered intravenously on Day 1 of each cycle, for 4 cycles
Followed by Nivolumab administered every 2 weeks until PD or discontinuation due to toxicity | |
Arm O: Nivolumab + Ipilimumab | Experimental | Nivolumab at specified dose/schedule until PD or discontinuation due to toxicity
Ipilimumab at specified dose/schedule until PD or discontinuation due to toxicity | |
Arm P: Nivolumab + Ipilimumab | Experimental | Nivolumab at specified dose/schedule until PD or discontinuation due to toxicity
Ipilimumab at specified dose/schedule until PD or discontinuation due to toxicity | |
Arm Q: Nivolumab + Ipilimumab | Experimental | Nivolumab at specified dose/schedule until PD or discontinuation due to toxicity
Ipilimumab at specified dose/schedule until PD or discontinuation due to toxicity | |
Arm R: Nivolumab + Ipilimumab | Experimental | Nivolumab at specified dose/schedule until PD or discontinuation due to toxicity
Ipilimumab at specified dose/schedule until PD or discontinuation due to toxicity | |
Arm S: Nivolumab + Ipilimumab | Experimental | Nivolumab at specified dose/schedule until PD or discontinuation due to toxicity
Ipilimumab at specified dose/schedule until PD or discontinuation due to toxicity | |