Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

Phase 3 Active not recruiting 317 enrolled Exelixis

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, randomized (2:1), open-label, controlled Phase 3 trial of XL092 in combination with nivolumab versus sunitinib in subjects with unresectable, locally advanced or metastatic nccRCC who have not received prior systemic anticancer therapy.

Timeline

Start: 2023-01-01
Primary completion: 2025-07
Completion: 2028-06

Publications

Pal SK, Powles T, Kanesvaran R, Molina-Cerrillo J, Feldman DR, Barata P, Liu M, Bhatt A, Wang Z, Nandoskar P, Suarez C. STELLAR-304: a phase III study of zanzalintinib (XL092) plus nivolumab in advanced non-clear cell renal cell carcinoma. Future Oncol. 2025 Mar;21(7):787-794. doi: 10.1080/14796694.2025.2458395. Epub 2025 Feb 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	—	—
Comparator	Sunitinib	Small molecule	—	—
Subject	Zanzalintinib	Small molecule	—	Oral

Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

Summary

Timeline

Publications

Drugs

Indications