Date: 2017-03-22
Type of
information: Treatment of the first patient
phase: 1-2
Announcement: treatment of the first patient
Company: Aveo Oncology (USA - MA)
Product: nivolumab and tivozanib (N-{2-Chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-N´-(5-methyl-3-isoxazolyl) urea hydrochloride monohydrate) and Opdivo® (nivolumab)
Action
mechanism: kinase inhibitor/tyrosine kinase inhibitor/monoclonal antibody/immune checkpoint inhibitor. Opdivo® (nivolumab) is an investigational human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells.
Tivozanib is an oral, potent, selective inhibitor of vascular endothelial growth factor tyrosine kinase inhibitor (VEGF TKI) with a long half-life and activity against all three VEGF receptors.
Disease: advanced renal cell carcinoma
Therapeutic
area: Cancer - Oncology
Country: France
Trial
details:
Latest
news:
- • On March 22, 2017, Aveo Oncology announced that the first patient has been dosed in the Phase 1/2 AVEO-sponsored TiNivo trial evaluating tivozanib in combination with BMS’ anti-PD-1 therapy, Opdivo® (nivolumab), in advanced renal cell carcinoma. The study, which will be led by the Institut Gustave Roussy in Paris, is under the direction of Professor Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. The Phase 1 trial will evaluate the safety of tivozanib in combination with nivolumab at escalating doses of tivozanib and, assuming favorable results, is expected to be followed by an expansion Phase 2 cohort at the established combination dose.Aveo looks forward to initial results from the Phase 1 portion of the TiNivo trial in the first half of 2017.
- • On February 9, 2017, Aveo Oncology announced clinical and regulatory updates for tivozanib. The Phase 1/2 Aveo-sponsored TiNivo trial evaluating tivozanib in combination with BMS' anti-PD-1 therapy, Opdivo® (nivolumab), in advanced renal cell carcinoma is scheduled to open sites for enrollment in early March, with dosing of the first patient expected in the same timeframe. The company received approval by the French National Agency for Medicines and Health Products Safety (ANSM) to initiate the study and is currently labelling the nivolumab supply provided by BMS or use in the trial.
- • On August 15, 2016, Aveo Oncology announced the initiation of a clinical evaluation of Aveo’s oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), tivozanib, in combination with BMS' anti-PD-1 therapy, Opdivo® (nivolumab), in advanced renal cell carcinoma (RCC). BMS will supply nivolumab for use in the Phase 1/2 AVEO-sponsored TiNivo trial.
Is
general: Yes
