Phase 3 STRIKE trial to assess disease-free survival of adjuvant tivozanib plus pembrolizumab in high-risk RCC

Dr. Bradley McGregor, director of clinical research at the Lank Center of Genitourinary Oncology, outlined the key objectives of the ongoing phase 3 STRIKE trial (NCT06661720). The study evaluates the combination of tivozanib and pembrolizumab as adjuvant therapy for patients with high-risk renal cell carcinoma.

The primary endpoint is disease‑free survival, while overall survival is the main secondary endpoint. Additional secondary measures include the incidence of adverse events and overall tolerability of the regimen.

Beyond these clinical outcomes, the trial incorporates extensive blood‑based analyses to identify biomarkers of minimal residual disease and to understand why the therapy works in certain patients. These exploratory studies aim to refine future treatment strategies for RCC.