Treatment-related adverse events occurring in ≥15% of patients in either treatment arm (all-subjects-as-treated population)
| Event, n (%) | Pembrolizumab + dabrafenib + trametinib n=60 | Placebo + dabrafenib + trametinib n=60 | ||
| Any grade | Grade 3–5* | Any grade | Grade 3–5 | |
| Any event | 57 (95.0) | 35 (58.3) | 56 (93.3) | 15 (25.0) |
| Gastrointestinal disorders | ||||
| Diarrhea | 17 (28.3) | 2 (3.3) | 7 (11.7) | 0 (0.0) |
| Nausea | 16 (26.7) | 0 (0.0) | 18 (30.0) | 0 (0.0) |
| Vomiting | 12 (20.0) | 0 (0.0) | 11 (18.3) | 0 (0.0) |
| General disorders and administration site conditions | ||||
| Asthenia | 15 (25.0) | 0 (0.0) | 7 (11.7) | 2 (3.3) |
| Chills | 21 (35.0) | 0 (0.0) | 23 (38.3) | 1 (1.7) |
| Fatigue | 16 (26.7) | 1 (1.7) | 23 (38.3) | 0 (0.0) |
| Fever | 43 (71.7) | 6 (10.0) | 41 (68.3) | 2 (3.3) |
| Investigations | ||||
| ALT increased | 12 (20.0) | 2 (3.3) | 10 (16.7) | 2 (3.3) |
| AST increased | 12 (20.0) | 4 (6.7) | 12 (20.0) | 2 (3.3) |
| Blood ALP | 8 (13.3) | 1 (1.7) | 11 (18.3) | 1 (1.7) |
| GGT increased | 5 (8.3) | 4 (6.7) | 9 (15.0) | 3 (5.0) |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 18 (30.0) | 2 (3.3) | 12 (20.0) | 0 (0.0) |
| Myalgia | 10 (16.7) | 0 (0.0) | 9 (15.0) | 1 (1.7) |
| Skin and subcutaneous tissue disorders | ||||
| Dermatitis acneiform | 9 (15.0) | 0 (0.0) | 4 (6.7) | 0 (0.0) |
| Pruritus | 9 (15.0) | 0 (0.0) | 6 (10.0) | 0 (0.0) |
| Rash | 22 (36.7) | 3 (5.0) | 16 (26.7) | 0 (0.0) |
| Vitiligo | 12 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
*One patient in the triplet arm had grade 5 treatment-related pneumonitis.
ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyltransferase.