Phase 1/2 Study of Tivozanib in Combination With Nivolumab in Subjects With RCC
Status:
Active, not recruiting
Trial end date:
2021-07-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the safety, tolerability, dose-limiting toxicities, MTD, and
preliminary anti-tumor activity of tivozanib in combination with nivolumab in subjects with
metastatic renal cell cancer. This will use a standard '3+3' dose-escalation trial design. A
cohort of 3 subjects will be enrolled at each dose level. If 1 of 3 subjects experiences a
DLT during Cycle 1, that dose level will be expanded to 6 subjects. If 0 of 3 or ≤ 1 of 6
subjects experience a DLT during Cycle 1, escalation to the next dose will occur. If ≥ 2 of 6
subjects experience a DLT during Cycle 1, dose escalation will stop and the prior dose will
be considered the MTD. This is a validated trial design for Phase 1 trials.
Following completion of the dose-escalation cohorts and determination of MTD, an expansion
cohort of up to 20 subjects may be enrolled at MTD to further evaluate safety, tolerability,
and preliminary anti-tumor activity of tivozanib in combination with nivolumab in the same
target population.