TIVO-3: Phase 3 trial of Tivozanib vs. Sorafenib as 3
rd
or 4
th
line
EudraCT) Number :2015-003607-30
McTigue M, et al. PNAS 2012
Eligibility:
§
Subjects with recurrent
metastatic RCC who have failed 2
or 3 prior systemic regimens,
one of which includes a VEGFR
TKI
§
Clear Cell Component
§
Excluded >3 prior regimens
Tivozanib: 1.5 mg
(3 wk on/ 1 wk off)
Sorafenib: 400 mg orally
twice daily
R
A
N
D
O
M
I
Z
A
T
I
O
N
§
Primary end point: PFS based on BICR
§
Secondary end points:
ORR, OS, Safety
N=322
Stratification factors:
• ECOG PS (0 vs 1)
• Prior therapy with PD-1/PDL-1 (Y/N)
