SAS Output

21-JUL-2017 18:10

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 280 162 57 33 17 5 2 09/19/2014 243 104
            162 57 33 17 5 2      
 
    2 Y 2 Continuous Dosing 280 64 22 11 7 1 1 09/19/2014    
        3 Intermittent Dosing   64 23 11 4 0 0      
            128 45 22 11 1 1      
 
  S1404-Melan, Adv, HD-IFN/Ipilimumab vs MK-3475 1 Y 1 Tissue for PD-L1 testing 1378 1302 1024 538 254 94 24 11/10/2015 413 175
            1302 1024 538 254 94 24      
 
    2 Y 2 FDA approved regimen 1378 605 483 267 126 48 15 11/10/2015    
        3 MK-3475 (Pembrolizumab)   589 474 249 115 40 8      
            1194 957 516 241 88 23      
 
  S1512-Melan, Adv, Desmoplastic, MK-3475 (pembro) 1 Y 1 MK-3475 (pembrolizumab) 77 1 1 1 0 0 0 02/06/2017 62 26
            1 1 1 0 0 0      
 
Yes EA6134-Adv, BRAF mut, D+T/Ipi+Niv vs Ipi+Niv/D+T 1 E Total Registrations   16 9 3 1 0 0 11/03/2015 338 140
            16 9 3 1 0 0      
 
    2 E Total Registrations   4 4 1 1 1 0 11/03/2015    
            4 4 1 1 1 0      
 
  EA6141-Melan, Avd, Nivolumab+Ipi ± Sargmostim 1 E Total Registrations   36 29 21 15 4 0 03/25/2016 298 120
            36 29 21 15 4 0      
 
No E3612-MELAN,Adv Ipilimumab±Bevacizumab 1 E Total Registrations   5 1 0 0 0 0 02/16/2015 147 56
            5 1 0 0 0 0      
 

21-JUL-2017 18:10

MELAN Open Studies with No Registrations

The REPORT Procedure

Detailed and/or summarized report

Table 1

Study Registration/Phase Open Date
S1616 MELAN,, Adv, Ipilimumab ± Nivolumab 1 Randomization 17-Jul-17