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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
NCT06082167 · View on ClinicalTrials.gov ↗
Study 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 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.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Zanzalintinib
- DRUG Zanzalintinib-matched Placebo
Study Locations (20)
Other
- Exelixis Clinical Site #91 — Buenos Aires
- Exelixis Clinical Site # 47 — Ciudad Autonoma de Buenos Aire
- Exelixis Clinical Site #53 — Ciudad Autonoma de Buenos Aire
- Exelixis Clinical Site #93 — Córdoba
Florida
- Exelixis Clinical Site #1 — Orange City
- Exelixis Clinical Site #163 — Tampa
Georgia
- Exelixis Clinical Site #123 — Athens
- Exelixis Clinical Site #82 — Atlanta
Iowa
- Exelixis Clinical Site #62 — Des Moines
- Exelixis Clinical Site #100 — Iowa City
North Carolina
- Exelixis Clinical Site #95 — Durham
- Exelixis Clinical Site #117 — Wilson
California
- Exelixis Clinical Site #2 — Fullerton
Illinois
- Exelixis Clinical Site #19 — Chicago
Missouri
- Exelixis Clinical Site #4 — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2024-06-07 |
| Est. Completion | 2029-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06082167
The ClinicalTrials.gov registry entry for NCT06082167 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Exelixis, which has 54 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06082167 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06082167 about?
NCT06082167 is a clinical study titled "Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in 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 squa...
What is the current status of trial NCT06082167?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 600 participants. The study started on 2024-06-07. Estimated completion is 2029-03.
What conditions does trial NCT06082167 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06082167?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Zanzalintinib (DRUG), Zanzalintinib-matched Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06082167?
This trial is sponsored by Exelixis, which has 54 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06082167 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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