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

“Beyond [the primary and secondary end points]…we're collecting blood and doing [analyses] to see who needs this therapy, why does this therapy work, [and whether there] are there markers of minimal residual disease. These studies behind the study are hopefully going to be what we learn even more from in the future as we look to further improve outcomes for patients.”

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 end points that will be evaluated in the ongoing phase 3 STRIKE trial (NCT06661720) evaluating adjuvant tivozanib plus pembrolizumab (Keytruda) in patients with high-risk renal cell carcinoma (RCC). 

The primary end point of STRIKE is disease-free survival, McGregor began. Overall survival represents a key secondary end point, he added; other secondary end points include the incidence of adverse effects and the tolerability of the combination. McGregor noted that the study investigators opted to not evaluate DFS and OS as coprimary end points due to time constraints and trial logistic considerations.

The study authors will also be collecting data and evaluating biomarkers of response and minimal residual disease, McGregor said. These exploratory analyses will be key in determining which patients are good fits for this approach and further understanding why the treatment works, he concluded.

In STRIKE, patients will be randomly assigned to receive intravenous pembrolizumab plus tivozanib or pembrolizumab alone. In both arms, pembrolizumab will be administered on days 1 and 43 of each cycle, or on days 1, 22, 43 and 64 of each cycle; cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. In the investigational arm, patients will receive oral tivozanib daily on days 1 through 21, days 29 through 49, and days 57 through 77 of each cycle for up to 6 months.