- Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system
- Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma
- Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
Other protocol defined inclusion/exclusion criteria could apply
- Participants must not have active brain metastases or leptomeningeal metastases
- Participants must not have uveal melanoma
- Participants must not have an active, known, or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria could apply
Characteristics
RELA+NIVO
NIVO
Agedc-comma sex
Median age (range) yr
63.0 (20–94)
62.0 (21–90)
Female - no.(%)
145 (40.8)
153 (42.6)
Previous systemic therapy - no.(%)
Adjuvant
31 (8.7)
26 (7.2)
Neoadjuvant
2 (0.6)
1 (0.3)
Unknown or other
0
2 (0.6)
Metastasis stage - no.(%)
M1a or b
162 (45.6)
195 (54.3)
M1c
151 (42.5)
127 (35.4)
Melanoma subtype classification - no.(%)
Cutaneous acral
41 (11.5)
41 (11.4)
Cutaneous nonacral
249 (70.1)
254 (70.8)
Mucosal
23 (6.5)
28 (7.8)
Other
42 (11.8)
36 (10.0)
ECOG PS - no.(%)
LDH level - no.(%)
>ULN
130 (36.6)
128 (35.7)
>2x ULN
32 (9.0)
31 (8.6)
Sites with ≥1 lesion - no.(%)
LAG-3 expression - no.(%)
≥1%
268 (75.5)
269 (74.9)
PD-L1 expression - no.(%)
≥1%
146 (41.1)
147 (40.9)
<1%
209 (58.9)
212 (59.1)
<5%
267 (75.2)
273 (76.0)
BRAF status - no.(%)
BRAF MTdc-plus
136 (38.3)
139 (38.7)
BRAF MT-
219 (61.7)
220 (61.3)
Metastasis stage with LDH level - no.(%)
M0dc-comma M1 and normal LDH level
232 (65.4)
237 (66.0)
M1 and elevated LDH level
123 (34.6)
122 (34.0)
Other
Median tumor burden (range) - mm
59.0 (10–317)
54.5 (10–548)
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