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NCT06082167 · ClinicalTrials.gov record · last posted 2025-08-17

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

Study acronym: STELLAR-305
StatusActive, Not Recruiting
PhasePhase 2/3
SponsorExelixis
Started2024-06-07
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from the ClinicalTrials.gov record
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.

Amendment record 11 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 11 times since 2023-10-09; most recent amendment 2025-08-13. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-08-13
Status change Recruiting→Active, Not Recruitingv11
2023-12-20
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT06082167
Lead Sponsor Exelixis
Collaborators: Merck Sharp & Dohme LLC
Conditions Head and Neck Squamous Cell Carcinoma
Enrollment 600 participants
Start Date 2024-06-07
Primary Completion 2028-08 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2025-08-17