Dr McGregor on the STRIKE Trial of Tivozanib Plus Pembrolizumab in RCC

“Combination therapy can improve outcomes in the adjuvant setting. In STRIKE, [which is evaluating] a potentially more potent combination therapy, we can hopefully achieve even greater benefits. STRIKE is an incredibly important trial and it's enrolling across the United States.”

Bradley McGregor, MD, the Director of Clinical Research for the Lank Center of Genitourinary Oncology, an institute physician, and the Marra Lochiatto Investigator at Dana-Farber Cancer Institute, as well as an assistant professor of medicine at Harvard Medical School, discussed the rationale for the phase 3 STRIKE trial (NCT06661720).

STRIKE is comparing adjuvant tivozanib plus pembrolizumab (Keytruda) vs pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). The primary end point is disease-free survival (DFS). Secondary end points include overall survival (OS) and safety and tolerability.

McGregor explained that offering systemic therapy earlier to prevent disease recurrence after surgery is often the preferable approach to treat patients with metastatic RCC. Although pembrolizumab has been shown to improve DFS and OS in patients with high-risk RCC, there are a substantial proportion of patients who will experience disease relapse despite receiving the agent, he added.

Findings from the phase 3 LITESPARK-022 trial (NCT05239728) presented during the 2026 Genitourinary Cancers Symposium demonstrated that patients with clear cell RCC at an increased risk of recurrence following nephrectomy achieved a statistically significant and clinically meaningful improvement in DFS with pembrolizumab plus belzutifan (Welireg) vs pembrolizumab alone (HR, 0.72; 95% CI, 0.59-0.87; P = .0003), McGregor noted. OS data from the trial remain immature, he added. Data from LITESPARK-022 support that rationale for STRIKE, showing that combination therapy can improve outcomes for patients in the adjuvant setting, he explained.

STRIKE is enrolling patients across academic and community sites in the United States, McGregor noted. Over 270 patients are currently enrolled on the trial, he concluded.