Combination treatment with immunotherapy agents and/or vascular endothelial growth factor tyrosine kinase inhibitors are a standard of care for patients with advanced clear cell renal cell carcinoma (ccRCC).
Novel therapeutic combinations that include the hypoxia-inducible factor 2α inhibitor belzutifan and the cytotoxic T-lymphocyte-associated protein 4 inhibitor quavonlimab are being investigated for their potential to further improve patient outcomes. This protocol describes the rationale and design of the randomized, phase III LITESPARK-012 study, which will evaluate the efficacy and safety of pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab as first-line treatment for advanced ccRCC. Results from this study may support triplet combination therapies as a potential new standard of care for advanced ccRCC. Clinical trial registry: NCT04736706 (ClinicalTrials.gov).
Future oncology (London, England). 2023 Oct 26 [Epub ahead of print]
Toni K Choueiri, Thomas Powles, Martin H Voss, Elizabeth R Plimack, Howard Gurney, Yue Song, Rodolfo F Perini, Karla Rodriguez-Lopez, Brian I Rini
Dana-Farber Cancer Institute & Harvard Medical School, Boston, MA, USA., Barts Health NHS Trust & the Royal Free NHS Foundation Trust, Barts Cancer Institute, Queen Mary University of London, London, UK., Memorial Sloan Kettering Cancer Center, New York, NY, USA., Fox Chase Cancer Center, Philadelphia, PA, USA., Westmead Hospital, Sydney, NSW, Australia., Merck & Co., Inc., Rahway, NJ, USA., Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.