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Combining Tivozanib and Nivolumab in Advanced Renal Cell Carcinoma

By: Sarah Campen, PharmD
Posted: Monday, January 4, 2021

The combination therapy of tivozanib plus nivolumab appears to have a tolerable safety profile and “promising” antitumor efficacy in patients with metastatic renal cell carcinoma, according to the results of a phase Ib/II study published in Annals of Oncology. “The results of the TiNivo trial demonstrate that treatment with tivozanib and nivolumab resulted in notable drug tolerability, with minimal off-target effects, and durable [objective response rate] among patients with treatment-naive or previously treated advanced renal cell carcinoma,” stated Laurence Albiges, MD, PhD, of the Gustave Roussy Institute, Villejuif, France, and colleagues.

Patients enrolled in phase Ib received tivozanib at 1 mg daily for 21 days followed by 7 days off treatment (n = 3) or tivozanib at 1.5 mg daily (n = 3) plus nivolumab at 240 mg every 2 weeks. In phase II, 22 additional patients received tivozanib at 1.5 mg daily, the maximum tolerated dose determined from phase Ib.

In all, 25 patients were treated with tivozanib at 1.5 mg daily; 48% were treatment-naive, and 52% were previously treated. The objective response rate was 56%—including one complete response—and the disease control rate was 96%, with a median time to best response of 7.9 weeks. Tumor shrinkage was observed in 20 patients (80%). After a median follow-up of 19 months, the median progression-free survival was 18.9 months in all patients and was similar in treatment-naive and previously treated patients.

As for safety, treatment-related grade 3 and 4 adverse events were reported in 20 patients (80%). Hypertension was the most common grade 3 or 4 adverse event, experienced by 13 patients (52%). Adverse events led to dose reduction in four patients (17%) and treatment discontinuation in eight patients (32%).

Disclosure: For full disclosures of the study authors, visit

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