A Phase 3 clinical trial (NCT04987203) investigating nivolumab in combination with tivozanib for advanced renal cell carcinoma reached its primary completion on September 30, 2025. The study enrolled 343 participants to compare the combination therapy against tivozanib monotherapy.
Background
The trial, titled "Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma," focuses on patients with advanced renal cell carcinoma who have received 1 or 2 prior lines of therapy, including an Immune Checkpoint Inhibitor (ICI). Nivolumab is an immune checkpoint inhibitor, and its combination with tivozanib, a tyrosine kinase inhibitor, is being explored in this patient population.
Trial design
The Phase 3 study (NCT04987203) is designed to compare tivozanib in combination with nivolumab to tivozanib monotherapy. The trial enrolled 343 subjects with advanced renal cell carcinoma. The study population includes those who have previously undergone 1 or 2 lines of therapy, with at least one being an Immune Checkpoint Inhibitor.
What this means
The primary completion of this Phase 3 trial signifies that the main data collection period for the study's primary endpoint has concluded. While specific results are not yet available, the completion of this stage is a critical milestone. Researchers and clinicians will anticipate the release of data from this study to understand the potential role of nivolumab in combination with tivozanib for patients with advanced renal cell carcinoma who have received prior treatment, including an Immune Checkpoint Inhibitor.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT04987203, titled "Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma," was posted on 2025-09-30 on clinicaltrials.gov.