Table 1.

Patient characteristics

Total patients, 53; mean age, 65
RespondersNonresponders
Number of patients (M/F)19 (16/3)34 (24/10)
Mean age (M/F)68 (69/65)54 (66/58)
Stage
 M000
 M1a34
 M1b87
 M1c823
Brain metastasis
 Yes54
 No1430
LDH
 Normal1718
 Elevated216
BRAF status
 Wild type1422
 V600E positive38
 V600E heterozygous10
 K601E positive01
 Others (NRAS mutated + monosomy 3)13
Prior treatment
 None43
 Radiation only (R)14
 Chemotherapy only (C)00
 Immunotherapy only (I)410
  BCG10
  IFN (interferon)02
  Ipilimumab22
  Ipilimumab + IFN01
  Ipilimumab + IL205
 Targeted therapy only (T)00
 Adoptive cell therapy (A)20
 Combined treatment1017
  I + C14
  I + R54
  I + T01
  R + C01
  I + R + C01
  I + T + A10
  I + R + T23
  I + T + C01
  I + C + T + R02
  I + C + T + R + A10
Toxicities (adverse effects)
 Fatigue (grades 1–2)22
 Colitis (grades 1–3)21
 Pneumonitis (grades 1–2)11
 Myalgia (grades 1–2)01
 Vitiligo31
 Diverticulitis (grades 1–2)10
 Liver function test abnormality, grade 301
 Acute kidney injury, grade 410
Dose of PD-1 antibody
 2 mg/kg414
 10 mg/kg1518
Response
 Partial response (PR)12
 Stable disease (SD)31
 Complete response (CR)4
 Partial response followed by progression1
 Progression of disease (PD)32
Reason for study discontinuation
 Adverse events2
 PD31
 CR1
 Investigator decision1

Abbreviations: BCG, Bacillus Calmette-Guerin; LDH, lactate dehydrogenase.