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

Status
Active
Cancer Type
Head and Neck Cancer
Unknown Primary
Trial Phase
Phase II
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06082167
Protocol IDs
XL092-305 (primary)
NCI-2024-03938
EU CTR: 2023-506308-24-00
Study Sponsor
Exelixis Inc

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 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.

Eligibility

  1. Histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapy.
  2. Subjects 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.
  3. The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, and larynx.
  4. PD-L1 expression level Combined Positive Score (CPS) = 1 by immunohistochemistry (IHC) testing.
  5. Have human papilloma virus (HPV) testing result for oropharyngeal cancer defined as p16 IHC testing.
  6. Measurable disease according to RECIST 1.1 determined by the Investigator.
  7. Tumor samples (archival or fresh tumor biopsy) are required. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization.
  8. 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.
  9. Age 18 years or older on the day of consent.
  10. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  11. Adequate organ and marrow function.

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