At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 343 enrolled
Drug / intervention
Tivozanib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line Has an Immune Checkpoint Inhibitor
In Brief
A Phase 3 clinical trial evaluating Tivozanib and Nivolumab for Renal Cell Carcinoma. Completed, enrolled 343 participants across 139 sites in 16 countries.
Detailed Summary
This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Cell Carcinoma
CountriesArgentina, Australia, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Italy, Mexico, Poland, Portugal, Spain, United Kingdom, United States
CollaboratorsParexel, Bristol-Myers Squibb
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedAug 2021
Enrollment StartSep 2021
Primary CompletionJan 2026
TodayJul 2026
First PostedAug 3, 2021
Enrollment StartSep 9, 2021
Primary CompletionJan 20, 2026
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 4.9 years ago
Interventions
Tivozanibdrug
Tivozanib will be administered orally.
Nivolumabdrug
Nivolumab will be administered via intravenous infusion.