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# Aveo Phase 3 Trial Misses Primary Endpoint
- URL: https://www.fdaweb.com/aveo-phase-3-trial-misses-primary-endpoint/
- Published: 2024-07-18T12:00:00.000Z
- Updated: 2026-09-14T14:35:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157379

Aveo Oncology says its TiNivo-2 Phase 3 clinical trial in patients with advanced metastatic renal cell carcinoma whose tumors had progressed following prior immune checkpoint inhibitor treatment did not meet the primary endpoint of increasing progression-free survival when nivolumab (Bristol Myers Squibb’s Opdivo) was added to low-dose Fotivda (tivozanib). A company [statement](https://www.aveooncology.com/aveo-oncology-an-lg-chem-company-announces-phase-3-renal-cell-carcinoma-clinical-trial-tinivo-2-results/?ref=fdaweb.com) says the trial’s control arm using Fotivda as monotherapy demonstrated a clinically meaningful outcome in median progression-free survival in the second-line following immune checkpoint inhibitor (ICI) combination therapy.

Aveo says the results are consistent with other recent Phase 3 renal cell carcinoma trials in a similar patient population that suggested there is no clinical benefit in rechallenging patients with immunotherapy after receiving ICI beyond progression on previous ICIs.

Fotivda is described as an oral, next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor. FDA approved it 3/10/21 to treat adults with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies.