Table 1.

Demographic and baseline characteristics of patients

CharacteristicNaïve to prior anti–PD-1/PD-L1 therapy (N = 9)Received prior anti–PD-1/PD-L1 therapy (N = 13)Total (N = 22)
Sex, n (%)
 Male6 (67)9 (69)15 (68)
 Female3 (33)4 (31)7 (32)
Age (years)
 Median676464
 Min, max46, 7834, 7734, 78
ECOG PS, n (%)
 07 (78)9 (69)16 (73)
 12 (22)4 (31)6 (27)
Stage at screening, n (%)
 IIIC03 (23)3 (14)
 IV9 (100)10 (77)19 (86)
  Ma4 (44)3 (23)4 (18)
  Mb2 (22)4 (31)6 (27)
  Mc3 (33)6 (46)9 (41)
Baseline LDH (U/L), mean (SD)397 (533)292 (198)335 (365)
 ≤ULN, n (%)8 (89)8 (62)16 (73)
 >1ULN to ≤2 ULN, n (%)04 (31)4 (18)
 >2ULN, n (%)1 (11)1 (8)2 (9)
BRAFV600E mutation, n (%)
 Wild-type6 (67)6 (46)12 (55)
 Mutated3 (33)3 (23)6 (27)
 Not tested04 (31)4 (18)
0/1/2/≥3 prior lines of therapy, n (%)4/4/1/00/1/4/84/5/5/8
 Anti-CTLA44 (44)12 (92)16 (73)
 Interferon2 (22)3 (23)5 (23)
 IL203 (23)3 (14)
 IL 1001 (8)1 (5)
 Chemotherapy05 (39)5 (23)
 BRAF or MEK inhibitor02 (15)2 (9)
Responded to prior anti–PD-1/PD-L1, n (%)NA3 (24)NA
Tissue involvement, n (%)a
 Liver2 (22)6 (46)8 (36)
 Lung5 (56)5 (39)10 (46)
 Bone2 (22)02 (9)
 Skin/subcutaneous tissue5(56)10 (77)15 (68)
 Lymph nodes6 (67)6 (46)12 (55)
 Other organs4 (44)5 (39)9 (41)
  • Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; NA, not applicable; SD, standard deviation; ULN, upper limit of normal.

  • aPatients may have >1 site of tissue involvement.