Table III.

Major studies investigating nivolumab [Opdivo®] (anti-PD-1 immunotherapy) to treat melanoma

Enrollment period	Trial phase/Identifier	Patients	Randomization / Dosing regimen(s)	Primary endpoint / Results	Median follow-up	Common severe (grade 3-5) irAEs:
2012-2014	Phase 3, CheckMate 037, NCT01721746	Previously treated, unresectable or metastatic ipilimumab-refractory melanoma; or (if BRAF V600 mutation-positive) ipilimumab + BRAF inhibitor-refractory melanoma, n=631	Nivolumab 3 mg/kg every 2 weeks, n=272 Chemotherapy (dacarbazine 1000 mg/m2 every 3 weeks or paclitaxel 175 mg/m2 combined with carboplatin area under the curve 6 every 3 weeks), n=133	OR: Nivolumab (n=120): 37.1% Chemotherapy (n=47): 10.6%	8.4 mo.	Nivolumab: 5% Chemotherapy: 9%
2013-2014	Checkmate 066, NCT01721772	Previously untreated melanoma without BRAF mutation, n=418	Nivolumab 3 mg/kg every 2 weeks and dacarbazinematched placebo every 3 weeks, n=210 Dacarbazine 1000 mg/m^2 BSA every 3 weeks and nivolumabmatched placebo every 2 weeks, n=208	1-year-OS: Nivolumab: 72.9% Dacarbazine: 42.1%	Nivolumab: 8.9 mo. Dacarbazine: 6.8 mo	Nivolumab: 11.7% Dacarbazine: 17.6%
2015	Phase 3, Checkmate 238, NCT02388906	Completely resected, advanced (stage IIIb, IIIc or IV) melanoma patients, n=906	Nivolumab 3 mg/kg every 2 weeks, n=453 Ipilimumab, 10 mg/kg every 3 weeks for 4 doses; then every 12 weeks, n=453	RFS in overall intention to treat group: Nivolumab: 70.5% Ipilimumab: 60.8%	18 mo.	Nivolumab: 14.4% Ipilimumab: 45.9%

Abbreviations: Investigator’s choice of chemotherapy (ICC); body surface area (BSA)