Table 3.
Systemic trAEs during the first 12 wk
| Adverse event | A: IFN-γ high NIVO (n = 10) | B: IFN-γ high NIVO + DOM BID (n = 10) | C: IFN-γ low NIVO + DOM BID (n = 10) | D: IFN-γ low IPI + NIVO + DOM QD (n = 10) |
D-exp: IFN-γ low IPI + NIVO + DOM BID (n = 4) |
|||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 1–2 | Grade 3 | Grade 1–2 | Grade 3 | Grade 1–2 | Grade 3 | Grade 1–2 | Grade 3 | Grade 1–2 | Grade 3 | |||||||||||
| Any adverse event | 10 | 100% | 0 | 0% | 8 | 80% | 2 | 20% | 6 | 60% | 4 | 40% | 8 | 80% | 2 | 20% | 0 | 0% | 4 | 100% |
| Skin rash | 3 | 30% | 0 | – | 3 | 30% | 2 | 20% | 3 | 30% | 4 | 40% | 2 | 20% | 0 | – | 1 | 25% | 3 | 75% |
| Fatigue | 6 | 60% | 0 | – | 2 | 20% | 0 | – | 5 | 50% | 0 | – | 6 | 60% | 0 | – | 1 | 25% | 0 | – |
| Pruritus | 3 | 30% | 0 | – | 1 | 10% | 0 | – | 3 | 30% | 0 | – | 3 | 30% | 0 | – | 3 | 75% | 0 | – |
| ALT increased | 1 | 10% | 0 | – | 2 | 20% | 0 | – | 4 | 40% | 1 | 10% | 2 | 20% | 0 | – | 2 | 50% | 0 | – |
| AST increased | 1 | 10% | 0 | – | 2 | 20% | 0 | – | 4 | 40% | 0 | – | 2 | 20% | 0 | – | 2 | 50% | 0 | – |
| Headache | 0 | – | 0 | – | 3 | 30% | 0 | – | 4 | 40% | 0 | – | 2 | 20% | 0 | – | 2 | 50% | 0 | – |
| Dry mouth | 1 | 10% | 0 | – | 4 | 40% | 0 | – | 1 | 10% | 0 | – | 1 | 10% | 0 | – | 1 | 25% | 0 | – |
| Fever | 0 | – | 0 | – | 1 | 10% | 0 | – | 3 | 30% | 1 | 10% | 1 | 10% | 0 | – | 2 | 50% | 0 | – |
| Lipase increased | 1 | 10% | 0 | – | 3 | 30% | 0 | – | 0 | – | 0 | – | 2 | 20% | 0 | – | 1 | 25% | 0 | – |
| Myalgia | 2 | 20% | 0 | – | 0 | – | 0 | – | 1 | 10% | 0 | – | 3 | 30% | 0 | – | 1 | 25% | 0 | – |
| Nausea | 0 | – | 0 | – | 2 | 20% | 0 | – | 2 | 20% | 0 | – | 3 | 30% | 0 | – | 0 | – | 0 | – |
| Arthralgia | 2 | 20% | 0 | – | 1 | 10% | 0 | – | 0 | – | 0 | – | 2 | 20% | 0 | – | 0 | – | 0 | – |
| Infusion-related reaction | 1 | 10% | 0 | – | 1 | 10% | 0 | – | 1 | 10% | 0 | – | 2 | 20% | 0 | – | 0 | – | 0 | – |
| Amylase increased | 0 | – | 0 | – | 2 | 20% | 0 | – | 1 | 10% | 0 | – | 2 | 20% | 0 | – | 0 | – | 0 | – |
| Diarrhea | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 3 | 30% | 1 | 10% | 0 | – | 0 | – |
| Gastrointestinal pain | 1 | 10% | 0 | – | 1 | 10% | 0 | – | 1 | 10% | 0 | – | 1 | 10% | 0 | – | 0 | – | 0 | – |
| Platelet count decreased | 0 | – | 0 | – | 0 | – | 0 | – | 1 | 10% | 0 | – | 1 | 10% | 0 | – | 2 | 50% | 0 | – |
| Hyperthyroidism | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 3 | 30% | 0 | – | 0 | – | 0 | – |
| Dysgeusia | 0 | – | 0 | – | 0 | – | 0 | – | 2 | 20% | 0 | – | 1 | 10% | 0 | – | 0 | – | 0 | – |
| Stomatitis | 0 | – | 0 | – | 0 | – | 0 | – | 1 | 10% | 0 | – | 0 | – | 0 | – | 0 | – | 1 | 25% |
| Acute kidney injury | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 0 | – | 1 | 10% | 0 | – | 0 | – |
Data are n (%). trAEsthat occurred in ≥5% of patients, and all grade 3–4 are displayed in the table. Within the first 12 wk, no grade 4 or 5 adverse events were observed. ALT, alanine aminotransferase; AST, aspartate aminotransferase; DOM, domatinostat; IPI, ipilimumab; NIVO, nivolumab.