NCT06661720 – A032201: Short TeRm Intensified Pembrolizumab (KEytruda) and Tivozanib for High-risk renal cell carcinoma – STRIKE
This Phase III trial is testing whether adding tivozanib to standard pembrolizumab therapy improves outcomes compared to pembrolizumab alone for patients with high risk clear cell renal cell carcinoma who have had all known kidney cancer removed through surgery, radiation, or ablation. Pembrolizumab given for one year after resection of localized high risk clear cell RCC has previously been shown to improve relapse free and overall survival, but about 20 percent of patients still relapse within two years, and no biomarker currently predicts who will respond to or need this additional therapy. Eligible patients are randomized 1:1 to receive pembrolizumab for 48 weeks, with or without tivozanib taken daily for 3 out of every 4 weeks for 6 months. The trial is sponsored by the Alliance for Clinical Trials in Oncology and is currently recruiting.