A Phase 3 clinical trial evaluating nivolumab in combination with tivozanib for advanced Renal Cell Carcinoma completed its primary study phase on 2026-01-20. The study compared the combination therapy to tivozanib monotherapy in patients who had received prior lines of therapy, including an Immune Checkpoint Inhibitor.
Background
Nivolumab is an immunotherapy drug. This trial focused on its use in advanced Renal Cell Carcinoma (RCC), a type of kidney cancer. Patients enrolled in the study had previously received 1 or 2 prior lines of therapy, with at least one being an Immune Checkpoint Inhibitor (ICI).
Trial design
The Phase 3 study (NCT04987203) enrolled 343 subjects with Renal Cell Carcinoma. The trial's objective was to compare tivozanib in combination with nivolumab to tivozanib monotherapy. Participants had advanced RCC and had undergone 1 or 2 prior lines of therapy, including an Immune Checkpoint Inhibitor.
What this means
The completion of the primary study phase for this Phase 3 trial indicates that data collection for the main endpoints has concluded. The study investigated a combination of tivozanib and nivolumab against tivozanib alone in a specific population of patients with advanced Renal Cell Carcinoma who had received prior treatments. The findings from this trial are now anticipated, which will provide insights into the potential efficacy and safety of this combination therapy in this patient group.
Source
Information regarding the primary completion of this clinical trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT04987203, titled "Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma," was updated with its primary completion status on 2026-01-20 on clinicaltrials.gov.