A Phase 2/3, Randomized, Double-Blind, Controlled Study of Zanzalintinib (XL092) in Combination With Pembrolizumab vs Pembrolizumab in First-Line Treatment of Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 2/3, Randomized, Double-Blind, Controlled Study of Zanzalintinib (XL092) in Combination With Pembrolizumab vs Pembrolizumab in First-Line Treatment of Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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.
Inclusion Criteria:
Histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapy.
PD-L1 expression level Combined Positive Score (CPS) ≥ 1.
Participants with oropharyngeal cancer must have human papillomavirus (HPV) status from tumor tissue.
Measurable disease according to RECIST 1.1 as determined by the Investigator.
Tumor samples (archival or fresh tumor biopsy) are required. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization.
Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
Age 18 years (or the legal age of consent in your country, if higher than 18) or older on the day of consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Adequate organ and marrow function.
Exclusion Criteria:
Ciudad Autonoma de Buenos Aire, C1015ABO, Argentina
Ciudad Autonoma de Buenos Aire, C1056ABJ, Argentina
Saint Priest En Jarez, Pays de la Loire Region 42270, France
Putrajaya, Kuala Lumpur 62250, Malaysia
Busan, Gangwon-do 49267, South Korea
Bangkoknoi, Bangkok 10700, Thailand