Table 1
| SWOG/ Support |
STUDY | R E G |
O P E N |
ARM | ACCR. GOAL |
TOTAL REGS. |
REGS. LAST 12 Month |
REGS. LAST 6 Month |
REGS. LAST 3 Month |
REGS. LAST 30 DAYS |
REGS. LAST 7 DAYS |
DATE OF FIRST REG. |
# of ACT. INSTs |
# of CURR IRBs |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SWOG | S1320-Adv, BRAF mut, Inter v Contin | 1 | N | 1 Lead-in Continuous Dosing | 248 | 249 | 31 | 14 | 6 | 0 | 0 | 09/19/2014 | 232 | 96 |
| 249 | 31 | 14 | 6 | 0 | 0 | |||||||||
| 2 | Y | 2 Continuous Dosing | 216 | 108 | 17 | 11 | 6 | 4 | 1 | 09/19/2014 | ||||
| 3 Intermittent Dosing | 103 | 16 | 12 | 5 | 1 | 0 | ||||||||
| 211 | 33 | 23 | 11 | 5 | 1 | |||||||||
| S1512-Melan, Adv, Desmoplastic, MK-3475 (pembro) | 1 | Y | 1 MK-3475 (pembrolizumab) | 77 | 25 | 14 | 7 | 4 | 0 | 0 | 02/06/2017 | 112 | 50 | |
| 25 | 14 | 7 | 4 | 0 | 0 | |||||||||
| S1607-MELAN, Adv, T-VEC, MK-3475 | 1 | Y | 1 T-VEC + MK-3475(pembrolizumab) | 64 | 18 | 17 | 10 | 5 | 1 | 0 | 06/05/2018 | 69 | 26 | |
| 18 | 17 | 10 | 5 | 1 | 0 | |||||||||
| S1616-MELAN, Adv, Ipilimumab ± Nivolumab | 1 | Y | 1 Ipilimumab | 94 | 12 | 8 | 4 | 3 | 2 | 0 | 10/23/2017 | 222 | 91 | |
| 2 Nivolumab + Ipilimumab | 31 | 21 | 11 | 6 | 2 | 1 | ||||||||
| 43 | 29 | 15 | 9 | 4 | 1 | |||||||||
| S1801-Melan, Adv, Adj vs Neoadj Pembrolizumab | 1 | Y | 1 Adjuvant Arm | 556 | 12 | 12 | 12 | 10 | 7 | 0 | 02/15/2019 | 269 | 102 | |
| 2 Neoadjuvant Pembrolizumab | 9 | 9 | 9 | 9 | 4 | 1 | ||||||||
| 21 | 21 | 21 | 19 | 11 | 1 | |||||||||
| 2 | Y | 3 Surgery | 556 | 11 | 11 | 11 | 9 | 7 | 0 | 02/15/2019 | ||||
| 11 | 11 | 11 | 9 | 7 | 0 | |||||||||
| 3 | Y | 4 Post-Surgery Pembro | 556 | 2 | 2 | 2 | 1 | 1 | 0 | 02/15/2019 | ||||
| 2 | 2 | 2 | 1 | 1 | 0 | |||||||||
| Yes | EA6134-Adv, BRAF mut, D+T/Ipi+Niv vs Ipi+Niv/D+T | 1 | E | Total Registrations | 38 | 12 | 8 | 3 | 1 | 0 | 11/03/2015 | 363 | 144 | |
| 38 | 12 | 8 | 3 | 1 | 0 | |||||||||
| 2 | E | Total Registrations | 14 | 7 | 2 | 2 | 0 | 0 | 11/03/2015 | |||||
| 14 | 7 | 2 | 2 | 0 | 0 | |||||||||
| EA6141-Melan, Avd, Nivolumab+Ipi ± Sargmostim | 1 | E | Total Registrations | 36 | 0 | 0 | 0 | 0 | 0 | 03/25/2016 | 221 | 93 | ||
| 36 | 0 | 0 | 0 | 0 | 0 | |||||||||
| No | EA6174-Merkel, Adjuvant Pembrolizumab vs Observation | 1 | E | Total Registrations | 1 | 1 | 1 | 1 | 0 | 0 | 05/01/2019 | 58 | 24 | |
| 1 | 1 | 1 | 1 | 0 | 0 | |||||||||