drugset / Trial / NCT04987203
Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma
Phase 3
Completed
343 enrolled
AVEO Pharmaceuticals, Inc.
Bristol-Myers Squibb · collabParexel · collab
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2021-09-09
- Primary completion
- 2026-01-20
- Completion
- 2026-01-20
Publications
- Choueiri TK, Albiges L, Barthelemy P, Iacovelli R, Emambux S, Molina-Cerrillo J, Garmezy B, Barata P, Basu A, Bourlon MT, Moon H, Ratta R, McKay RR, Chehrazi-Raffle A, Hammers H, Heng DYC, Braendle E, Beckermann KE, McGregor BA, Motzer RJ. Tivozanib plus nivolumab versus tivozanib monotherapy in patients with renal cell carcinoma following an immune checkpoint inhibitor: results of the phase 3 TiNivo-2 Study. Lancet. 2024 Oct 5;404(10460):1309-1320. doi: 10.1016/S0140-6736(24)01758-6. Epub 2024 Sep 13.
- Yang Y, Psutka SP, Parikh AB, Li M, Collier K, Miah A, Mori SV, Hinkley M, Tykodi SS, Hall E, Thompson JA, Yin M. Combining immune checkpoint inhibition plus tyrosine kinase inhibition as first and subsequent treatments for metastatic renal cell carcinoma. Cancer Med. 2022 Aug;11(16):3106-3114. doi: 10.1002/cam4.4679. Epub 2022 Mar 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Subject | Tivozanib | Small molecule | 0.89 mg | Oral |
| Subject | Tivozanib | Small molecule | 1.34 mg | Oral |