Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (NCT06082167)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Exelixis Clinical Site #2 — Fullerton, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (168 Sites)
Showing the first 25 of 168 sites.
- Exelixis Clinical Site #2 — Fullerton, California
- Exelixis Clinical Site #1 — Orange City, Florida
- Exelixis Clinical Site #163 — Tampa, Florida
- Exelixis Clinical Site #123 — Athens, Georgia
- Exelixis Clinical Site #82 — Atlanta, Georgia
- Exelixis Clinical Site #19 — Chicago, Illinois
- Exelixis Clinical Site #62 — Des Moines, Iowa
- Exelixis Clinical Site #100 — Iowa City, Iowa
- Exelixis Clinical Site #4 — St Louis, Missouri
- Exelixis Clinical Site #148 — Lebanon, New Hampshire
- Exelixis Clinical Site #158 — Camden, New Jersey
- Exelixis Clinical Site #3 — Shirley, New York
- Exelixis Clinical Site #95 — Durham, North Carolina
- Exelixis Clinical Site #117 — Wilson, North Carolina
- Exelixis Clinical Site #43 — Roanoke, Virginia
- Exelixis Clinical Site #73 — Rosario, Santa Fe Province
- 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,
- Exelixis Clinical Site #64 — Córdoba,
- Exelixis Clinical Site #157 — Pergamino,
- Exelixis Clinical Site #92 — Santa Fe,
- Exelixis Clinical Site #57 — Port Macquarie, New South Wales
- Exelixis Clinical Site # 46 — Adelaide,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Head and Neck Squamous Cell Carcinoma
- Testing the Addition of an Anti-cancer Drug, Ipatasertib, to the Usual Immunotherapy Treatment (Pembrolizumab) in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck — Duarte, California
- MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients — Gilbert, Arizona
- Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01 — St Louis, Missouri
- Intensive Symptom Surveillance Guided by Machine Learning-Directed Risk Stratification in Patients With Non-Metastatic Head and Neck Cancer, The INSIGHT Trial — Buffalo, New York
- Neoadjuvant Targeting of Myeloid Cell Populations in Combination With Nivolumab in Head & Neck Ca — Baltimore, Maryland
Explore by condition: All Head and Neck Squamous Cell Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.