Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (NCT06082167)
🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (14 items).
Location: Exelixis Clinical Site #2 — Fullerton, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Nasopharynx, salivary gland or occult primary site (regardless of p16 status).
- Has disease that is suitable for local therapy administered with curative intent.
- Has received prior therapy with zanzalintinib, any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (for example, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
- Life expectancy \< 3 months.
- Had progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
- Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks prior to randomization.
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to randomization.
- Positive hepatitis B surface antigen (HBsAg) test.
- Positive hepatitis C virus (HCV) antibody test.
- Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to randomization. Complete wound healing from major or minor surgery must have occurred at least prior to randomization.
- Corrected QT interval calculated by the Fridericia formula (QTcF) \> 480 ms per electrocardiogram (ECG) within 28 days before randomization.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (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.