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NCT06082167 · ClinicalTrials.gov registry record · Phase 2
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 study of Head and Neck Squamous Cell Carcinoma, sponsored by Exelixis.
- Active
- Registry status
- Phase 2
- Development phase
- 600
- Enrollment target
- 20
- Study locations
NCT06082167 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma that is active but no longer recruiting, run by Exelixis. The registered enrollment target is 600 participants, above the 112-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (436% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT06082167, a Phase 2 study of Head and Neck Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Exelixis.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 600 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 112-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (436% higher). The listed sponsor is Exelixis, which has 48 total studies on file at ClinicalTrials.gov.
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.
NCT06082167 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, Florida, Georgia.
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.
What interventions are being tested in trial NCT06082167?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Zanzalintinib (DRUG), Zanzalintinib-matched Placebo (DRUG).
Who is sponsoring clinical trial NCT06082167?
This trial is sponsored by Exelixis, which has 48 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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