Table 1.
Pivotal international phase III studies and corresponding Japanese studies on targeted therapy and immunotherapy for melanoma
| Agents | Pivotal P3 studies | Corresponding Japanese studies |
|---|---|---|
| Metastatic setting | ||
| Molecularly targeted agents | ||
| Vemurafenib | BRIM-3 [30, 31] | JO28178 (P1/2) [32] |
| Dabrafenib | BREAK-3 [33] | BRF116056 (P1) [34] |
| Trametinib | METRIC [35] | MEK114784 (P1) [36] |
| Vemurafenib + Cobimetinib | coBRIM [24, 25] | Not done |
| Dabrafenib + Trametinib | COMBI-v [23], -d [20–22] | MEK116885 (P1/2) [29] |
| Encorafenib + Binimetinib | COLUMBUS [26, 27] | |
| Immune checkpoint inhibitors | ||
| Ipilimumab (3 mg) | CA184-002 [37] | CA184-396 (P2) [38] |
| Ipilimumab (10 mg) | CA184-024 [39] | CA184-202 (P2) [40] |
| Nivolumab (second line) | CheckMate 037 [41] | ONO-4538-02 (P2, 2 mg Q3w) [42] |
| Nivolumab (first line) | CheckMate 066 [43] | ONO-4538-08 (P2, 3 mg Q2w) [44] |
| Pembrolizumab | KEYNOTE-006 [45, 46] | KEYNOTE-041 (P1b) [47] |
| Nivolumab + Ipilimumab | CheckMate 067 [48, 49] | ONO-4538-17 (P2) [50•] |
| Adjuvant setting | ||
| Molecularly targeted agents | ||
| Vemurafenib | BRIM-8 [51] | Not done |
| Dabrafenib + Trametinib | COMBI-AD [52, 53] | |
| Immune checkpoint inhibitors | ||
| Ipilimumab (10 mg) | EORTC 18071 [54, 55] | Not done |
| Ipilimumab (3/10 mg) | E1609 [56] | Not done |
| Nivolumab | CheckMate 238 [57] | |
| Pembrolizumab | EORTC 1325/KEYNOTE-054 [58] | |
| Interferons | ||
| Pegylated interferon alfa | EORTC 18991 [59, 60] | MK-4031-370 (P1) [61] |
| Interferon beta | Not done | JCOG1309/J-FERON (P3) [62•] |
P, phase; Q2w, every 2 weeks; Q3w, every 3 weeks