Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Head and Neck Squamous Cell Carcinoma, sponsored by Exelixis.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Defined as the time from randomization to the earlier of either radiographic progressive disease (PD) per RECIST 1.1 as determined by the BICR or death from any cause
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 |
What the registry record for NCT06082167 still lists
NCT06082167 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 112-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (436% higher).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Head and Neck Squamous Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06082167's enrollment target sits among peer trials
600 2nd of 124 the highest of 124 other Head and Neck Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Phase II Study of Neoadjuvant Cetuximab and Cemiplimab in Patients Undergoing Surgery for HNSCC
RECRUITING · Phase 2
-
Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors
RECRUITING · Phase 2
-
Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial
RECRUITING · Phase 2
-
A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer
RECRUITING · Phase 2
-
Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)
RECRUITING · Phase 2
-
PD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00004317 · 600 participants · Phase 4
Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis
- NCT00209235 · 600 participants · NA
Albright Hereditary Osteodystrophy: Natural History, Growth, and Cognitive/Behavioral Assessments
- NCT01473784 · 600 participants · NA
Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck
- NCT01866371 · 600 participants
High Resolution Retinal Imaging
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI