STELLAR-304: A phase III study of zanzalintinib (XL092) plus nivolumab in advanced non-clear cell renal cell carcinoma Journal Article
| Authors: | Pal, S. K.; Powles, T.; Kanesvaran, R.; Molina-Cerrillo, J.; Feldman, D. R.; Barata, P.; Liu, M.; Bhatt, A.; Wang, Z.; Nandoskar, P.; Suarez, C. |
| Article Title: | STELLAR-304: A phase III study of zanzalintinib (XL092) plus nivolumab in advanced non-clear cell renal cell carcinoma |
| Abstract: | Management of advanced non-clear cell renal cell carcinoma (nccRCC) is challenging due to disease rarity and heterogeneity. The combination of multi-targeted tyrosine kinase inhibitor (TKI) with immune checkpoint inhibitor (ICI) has emerged as an effective treatment strategy, but well-designed, phase III randomized clinical trials are needed to demonstrate superiority over current treatment options. Zanzalintinib is a novel, multi-targeted TKI that has demonstrated promising preclinical anti-tumor activity in combination with ICIs. STELLAR-304 is a phase III trial evaluating first-line zanzalintinib plus nivolumab versus sunitinib in advanced nccRCC. Primary endpoints are progression-free survival and objective response rate. Secondary endpoint is overall survival. To our knowledge, STELLAR-304 is the first phase III study assessing a TKI-ICI combination in nccRCC patients across multiple subtypes. Clinical Trial Registration: This trial is registered at ClinicalTrials.gov (identifier: NCT05678673) |
| Keywords: | sunitinib; immunotherapy; diagnosis; tyrosine kinase inhibitor; everolimus; expression; phase iii; open-label; potential therapeutic target; c-met; rationale; immune checkpoint inhibitor; non-clear cell renal cell carcinoma; cabozantinib; nivolumab; zanzalintinib; xl092 |
| Journal Title: | Future Oncology |
| Volume: | 21 |
| Issue: | 7 |
| ISSN: | 1479-6694 |
| Publisher: | Future Medicine |
| Date Published: | 2025-01-01 |
| Start Page: | 787 |
| End Page: | 794 |
| Language: | English |
| ACCESSION: | WOS:001433380500001 |
| DOI: | 10.1080/14796694.2025.2458395 |
| PROVIDER: | wos |
| PMCID: | PMC11916370 |
| PUBMED: | 40008409 |
| Notes: | Article -- Source: Wos |
