Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Public ClinicalTrials.gov record NCT06082167. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06082167
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 600 participants
Conditions and interventions
Conditions
Interventions
- Zanzalintinib Drug
- Zanzalintinib-matched Placebo Drug
- Pembrolizumab Biological
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 7, 2024 (Actual)
- Primary completion
- Aug 2028 (Estimated)
- Completion
- Mar 2029 (Estimated)
- Last update posted
- Aug 17, 2025
2024 – 2029
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Exelixis Clinical Site #2 | Fullerton | California | 92835 | — |
| Exelixis Clinical Site #1 | Orange City | Florida | 32763 | — |
| Exelixis Clinical Site #163 | Tampa | Florida | 33612-9497 | — |
| Exelixis Clinical Site #123 | Athens | Georgia | 30607 | — |
| Exelixis Clinical Site #82 | Atlanta | Georgia | 30322 | — |
| Exelixis Clinical Site #19 | Chicago | Illinois | 60611 | — |
| Exelixis Clinical Site #62 | Des Moines | Iowa | 50309 | — |
| Exelixis Clinical Site #100 | Iowa City | Iowa | 52242 | — |
| Exelixis Clinical Site #4 | St Louis | Missouri | 63110 | — |
| Exelixis Clinical Site #148 | Lebanon | New Hampshire | 03756 | — |
| Exelixis Clinical Site #158 | Camden | New Jersey | 08103 | — |
| Exelixis Clinical Site #3 | Shirley | New York | 11967 | — |
| Exelixis Clinical Site #95 | Durham | North Carolina | 27710 | — |
| Exelixis Clinical Site #117 | Wilson | North Carolina | 27893 | — |
| Exelixis Clinical Site #43 | Roanoke | Virginia | 24014 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 153 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06082167, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 17, 2025 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06082167 live on ClinicalTrials.gov.