SAS Output

19-NOV-2017 6:10

MELAN ACCRUAL REPORT - Open and Recently Closed Studies

The REPORT Procedure

Detailed and/or summarized report

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 Y 1 Lead-in Continuous Dosing 280 185 62 38 19 10 6 09/19/2014 229 102
            185 62 38 19 10 6      
 
    2 Y 2 Continuous Dosing 280 74 25 17 7 2 1 09/19/2014    
        3 Intermittent Dosing   71 23 10 5 1 0      
            145 48 27 12 3 1      
 
  S1404-Melan, Adv, HD-IFN/Ipilimumab vs MK-3475 1 N 1 Tissue for PD-L1 testing 1378 1426 836 296 0 0 0 11/10/2015 390 170
            1426 836 296 0 0 0      
 
    2 Y 2 FDA approved regimen 1378 678 430 168 26 0 0 11/10/2015    
        3 MK-3475 (Pembrolizumab)   667 409 157 27 0 0      
            1345 839 325 53 0 0      
 
  S1512-Melan, Adv, Desmoplastic, MK-3475 (pembro) 1 Y 1 MK-3475 (pembrolizumab) 77 3 3 2 0 0 0 02/06/2017 73 31
            3 3 2 0 0 0      
 
  S1616-MELAN, Adv, Ipilimumab ± Nivolumab 1 Y 2 Nivolumab + Ipilimumab 94 2 2 2 2 2 1 10/23/2017   54
            2 2 2 2 2 1      
 
Yes EA6134-Adv, BRAF mut, D+T/Ipi+Niv vs Ipi+Niv/D+T 1 E Total Registrations   23 13 7 6 1 0 11/03/2015 350 144
            23 13 7 6 1 0      
 
    2 E Total Registrations   5 3 2 1 0 0 11/03/2015    
            5 3 2 1 0 0      
 
  EA6141-Melan, Avd, Nivolumab+Ipi ± Sargmostim 1 E Total Registrations   36 23 7 0 0 0 03/25/2016 312 126
            36 23 7 0 0 0      
 
No E3612-MELAN,Adv Ipilimumab±Bevacizumab 1 E Total Registrations   6 1 1 1 0 0 02/16/2015 116 42
            6 1 1 1 0 0      
 

19-NOV-2017 6:10

MELAN Open Studies with No Registrations

The REPORT Procedure

Detailed and/or summarized report

Table 1

Study Registration/Phase Open Date
S1607 MELAN, Adv, T-VEC, MK-3475 1 Registration 02-Oct-17