Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Summary

This is a multicenter, randomized, double-blind, controlled Phase 2/3 trial of zanzalintinib in combination with pembrolizumab versus zanzalintinib-matched placebo in combination with pembrolizumab in subjects with programmed death-ligand 1 (PD-L1) positive recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) incurable by local therapies who have not received prior systemic therapy for recurrent or metastatic disease.

Timeline

Start

2024-06-07

Primary completion

2028-08

Completion

2029-03

Publications

• Saba NF, Harrington K, Licitra L, Machiels JP, He C, Jew T, Andrianov V, Haddad R. STELLAR-305: phase II/III study of zanzalintinib plus pembrolizumab versus pembrolizumab alone in patients with HNSCC. Future Oncol. 2025 May;21(11):1349-1356. doi: 10.1080/14796694.2025.2485015. Epub 2025 Apr 18.

Drugs

Indications