Table 2.
Treatment disposition
| Treatment disposition | 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) | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Total cycles of NIVO | ||||||||||
| 1 | 0 | (0%) | 0 | (0%) | 0 | (0%) | 2A | (20%) | 0 | (0%) |
| 2 | 10 | (100%) | 10 | (100%) | 10 | (100%) | 8 | (80%) | 4 | (100%) |
| Total cycles of IPI | ||||||||||
| 1 | – | – | – | – | – | – | 2A | (20%) | 0 | (0%) |
| 2 | – | – | – | – | – | – | 8 | (80%) | 4 | (100%) |
| ICI cycles delayed | ||||||||||
| Due to trAE | 0 | (0%) | 0 | (0%) | 2 | (20%) | 1 | (10%) | 2 | (50%) |
| Domatinostat administration | ||||||||||
| Completed w/o modifications |
– | – | 6 | (60%) | 4 | (40%) | 8 | (80%) | 0 | (0%) |
| Interrupted |
– | – | 0 | (0%) | 2D | (20%) | 0 | (0%) | 0 | (0%) |
| Dose reduction |
– | – | 1B | (10%) | 2D | (20%) | 0 | (0%) | 0 | (0%) |
| Discontinued prematurely | – | – | 3 C | (30%) | 4C | (40%) | 2A | (20%) | 4 | (100%) |
|
Surgery
|
||||||||||
| Performed |
10 | (100%) | 10 | (100%) | 10 | (100%) | 10 | (100%) | 4 | (100%) |
| Delayed |
0 | (0%) | 1E | (10%) | 0 | (0%) | 0 | (0%) | 0 | (0%) |
| Brought forward | 0 | (0%) | 0 | (0%) | 1F | (10%) | 0 | (0%) | 0 | (0%) |
| Adjuvant therapy | ||||||||||
| Nivolumab | 10 | (100%) | 8 | (80%) | 7 | (70%) | 4 | (40%) | 1 | (25%) |
| Dabrafenib/trametinib | 0 | (0%) | 2 | (20%) | 2 | (20%) | 2 | (20%) | 3 | (75%) |
| Radiotherapy | 1 | (10%) | 1 | (10%) | 4 | (40%) | 4 | (40%) | 2 | (50%) |
Data are n (%). (A) Only 1 cycle IPI + NIVO + DOM due to grade 3 ir-nephritis (n = 1) and grade 2 ir-myalgia/arthralgia (n = 1). (B) Patient mistakenly took DOM 200 mg QD during first cycle instead of BID. (C) Prematurely discontinuation due to grade 2–3 DOM-related rashes/hypersensitivity reaction. (D) DOM interrupted and dose reduced in two patients due to grade 2 headaches. (E) Surgery delayed due to theater availability. (F) Surgery was brought forward due to fast clinical progression. DOM, domatinostat; ICI, immune checkpoint inhibition; IPI, ipilimumab; NIVO, nivolumab.