Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in 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
Sponsor: Exelixis + Merck Sharp & Dohme LLC
No open prediction endpoints
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Primary Endpoints (CT.gov)
Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR)
Time frame: Approximately 33 months after the first subject is randomized
Overall Survival (OS)
Time frame: Approximately 50 months after the first subject is randomized
Secondary Endpoints
PFS per RECIST 1.1 by Investigator
Objective Response Rate (ORR) per RECIST 1.1 by the BICR and Investigator
Duration of Response (DOR) Per RECIST 1.1 by BICR and Investigator
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapy. * Should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to randomization if given as part of multimodal treatment for locally advanced disease is allowed. * The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, and larynx. * 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 treatment…
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