Table 1.
Immunotherapy clinical trials in locally advanced and metastatic melanoma
| Trial name | Primary outcome | Treatment arms | Median OS (months) | Median PFS (months) | ORR (%) | 1 year-RFS (%) |
|---|---|---|---|---|---|---|
| KEYNOTE-006 [45, 46] | PFS, OS | Pembrolizumab q3w | 4.1 | 32.9 | – | |
| Pembrolizumab q2w | 32.7a | 5.6 | 33.7 | – | ||
| Ipilimumab | 16 | 3.4 | 11.9 | – | ||
| CheckMate 238 [47] | RFS | Ipilimumab | – | – | – | 60.8 |
| Nivolumab | – | – | – | 70.5 | ||
| CA184-024 | OS | Dacarbazine + ipilimumab | 11.2 | 3 | 15.2 | – |
| Dacarbazine | 9.1 | 3 | 10.3 | – | ||
| EORTC1325/KEYNOTE-054 [48] | RFS | Placebo | – | – | – | 61 |
| Pembrolizumab | – | – | – | 75.4 | ||
| CheckMate 067 [49] | PFS, OS | Nivolumab + ipilimumab | NR | 11.5 | 58 | – |
| Nivolumab | 36.9 | 6.9 | 45 | – | ||
| Ipilimumab | 19.9 | 2.9 | 19 | – | ||
| CheckMate 066 [50] | OS | Dacarbazine | 11.2 | 2.2 | 14.4 | – |
| Nivolumab | 37.5 | 5.1 | 42.9 | – | ||
| OPTiM [51] | Durable response lasting ≥ 6 months | T-VEC | 23.3 | Not reported | Not reported | – |
| GM-CSF | 18.9 | Not reported | Not reported | – | ||
| CA184-002 [52] | OS | Ipilimumab | 10.1 | 2.9 | 11 | – |
| gp100 vaccine | 6.4 | 2.8 | 1.5 | – | ||
| gp100 Vaccine + ipilimumab | 10 | 2.8 | 5.7 | – |
q2w every 2 weeks, q3w every 3 weeks, NR not reached, RFS relapse-free survival, PFS progression-free survival, OS overall survival, ORR overall response rate