The Phase 3 TiNivo-2 study tested whether adding nivolumab to tivozanib improves outcomes for patients with metastatic clear cell renal cell carcinoma (ccRCC) who progressed on prior immune checkpoint inhibitors (ICIs).
The trial found that combining nivolumab with tivozanib did not improve progression-free survival compared to tivozanib alone. However, tivozanib monotherapy remained highly effective in the second-line setting after ICI failure. Most patients were receiving their second-line treatment, and 70% had ICIs as their most recent therapy.
Experts recommend avoiding ICI “rechallenge,” as it adds toxicity and cost without benefit. Using a single-agent TKI like tivozanib preserves future treatment options and is well-tolerated, allowing patients to stay on therapy longer.
Overall, the study reinforces the role of tivozanib monotherapy as a safe and effective option after ICI failure in metastatic ccRCC.