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Table 2 Patient Demographics and Disease Characteristics at Baseline

From: Phase 1/2 study of epacadostat in combination with ipilimumab in patients with unresectable or metastatic melanoma

  25 mg BID (n = 8) 50 mg BID Cont’ (n = 18) 50 mg BID Int’ (n = 9) 75 mg Total Daily (n = 7) 100 mg BIDa (n = 1) 300 mg BIDa (n = 7) Total (N = 50)
Age
 Median (range), y 67 (34–81) 57 (25–78) 69 (49–77) 62 (35–81) 67 (67) 64 (47–81) 63 (25–81)
  ≤ 65 y, n (%) 3 (37.5) 14 (77.8) 2 (22.2) 4 (57.1) 0 5 (71.4) 28 (56.0)
White, n (%) 8 (100.0) 18 (100.0) 9 (100.0) 7 (100.0) 1 (100.0) 7 (100.0) 50 (100.0)
Men, n (%) 6 (75.0) 9 (50.0) 6 (66.7) 3 (42.9) 1 (100.0) 7 (100.0) 32 (64.0)
ECOG PS, n (%)
 0 5 (62.5) 16 (88.9) 6 (66.7) 6 (85.7) 1 (100.0) 4 (57.1) 38 (76.0)
 1 3 (37.5) 2 (11.1) 3 (33.3) 1 (14.3) 0 3 (42.9) 12 (24.0)
Current staging, n (%)
 IIIB 1 (12.5)b 0 0 0 0 0 1 (2.0)
 IIIC 0 0 2 (22.2) 0 0 0 2 (4.0)
 IV 7 (87.5) 18 (100.0) 7 (77.8) 7 (100.0) 1 (100.0) 7 (100.0) 47 (94.0)
Current M classification, n (%)
 0 0 0 2 (22.2) 0 0 0 2 (4.0)
 1a 1 (12.5) 3 (16.7) 0 2 (28.6) 0 2 (28.6) 8 (16.0)
 1b 2 (25.0) 1 (5.6) 1 (11.1) 1 (14.3) 0 0 5 (10.0)
 1c 5 (62.5) 14 (77.8) 6 (66.7) 4 (57.1) 1 (100.0) 5 (71.4) 35 (70.0)
Most common sites of metastases, n (%)
 Lymph nodes 3 (37.5) 12 (66.7) 4 (44.4) 3 (42.9) 0 6 (85.7) 28 (56.0)
 Lung 4 (50.0) 13 (72.2) 4 (44.4) 3 (42.9) 1 (100.0) 1 (14.3) 26 (52.0)
 Liver 2 (25.0) 6 (33.3) 3 (33.3) 3 (42.9) 0 1 (14.3) 15 (30.0)
 Abdomen 0 3 (16.7) 3 (33.3) 0 0 3 (42.9) 9 (18.0)
 Skin 1 (12.5) 4 (22.2) 1 (11.1) 1 (14.3) 0 2 (28.6) 9 (18.0)
 Adrenals 1 (12.5) 3 (16.7) 2 (22.2) 0 1 (100.0) 0 7 (14.0)
 CNS/brain 1 (12.5) 4 (22.2) 0 1 (14.3) 0 0 6 (12.0)
 Chest wall 0 2 (11.1) 0 1 (14.3) 0 2 (28.6) 5 (10.0)
 Breast 0 3 (16.7) 0 0 0 0 3 (6.0)
 Peritoneum 0 0 1 (11.1) 1 (14.3) 0 0 2 (4.0)
 Bone 0 0 0 0 0 1 (14.3) 1 (2.0)
 Pancreas 0 1 (5.6) 0 0 0 0 1 (2.0)
 Pleura 0 1 (5.6) 0 0 0 0 1 (2.0)
 Other 5 (62.5) 6 (33.3) 1 (11.1) 2 (28.6) 0 3 (42.9) 17 (34.0)
BRAF-mutant positive, n (%) 2 (25.0) 8 (44.4) 2 (22.2) 1 (14.3) 1 (100.0) 2 (28.6) 16 (32.0)
Elevated LDH level, n (%) 2 (25.0) 3 (16.7) 3 (33.3) 2 (28.6) 0 2 (28.6) 12 (24.0)
Prior radiation therapy, n (%) 4 (50.0) 8 (44.4) 2 (22.2) 3 (42.9) 0 3 (42.9) 20 (40.0)
Prior systemic regimens for advanced or metastatic disease, n (%) 1 (12.5) 12 (66.7) 3 (33.3) 2 (28.6) 1 (100.0) 4 (57.1) 23 (46.0)
Prior systemic therapy for advanced or metastatic disease, n (%)
 Immunotherapy 0 6 (33.3) 3 (33.3) 1 (14.3) 0 1 (14.3) 11 (22.0)
  Immune checkpoint inhibitor 0 3 (16.7) 2 (22.2) 1 (14.3) 0 0 6 (12.0)
  Interferon 0 3 (16.7) 1 (11.1) 0 0 1 (14.3) 5 (10.0)
  IL-2 0 1 (5.6) 1 (11.1) 0 0 0 2 (4.0)
  Other 0 1 (5.6) 1 (11.1) 0 0 0 2 (4.0)
 BRAF inhibitor 0 3 (16.7) 0 0 0 1 (14.3) 4 (8.0)
 Chemotherapy 0 2 (11.1) 0 1 (14.3) 0 2 (28.6) 5 (10.0)
 Other 0 4 (22.2) 1 (11.1) 2 (28.6) 1 (100.0) 1 (14.3) 9 (18.0)
  1. BID twice daily, CNS central nervous system, cont’ continuous, ECOG PS Eastern Cooperative Oncology Group performance status, IL-2 interleukin 2, int’ intermittent, LDH lactate dehydrogenase
  2. a Epacadostat 100-mg BID and 300-mg BID dose cohorts were not re-explored in this study after protocol amendment to evaluate lower doses of epacadostat
  3. b Patient was incorrectly staged as IIIB by study site; this patient had metastases in the liver and therefore should have been reported as stage IV