INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC (NCT06295731)
A Phase 2/3, Randomized Study of INBRX-106 Combined With Pembrolizumab Versus Pembrolizumab as First Line Treatment for Patients With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Expressing PD-L1 (CPS ≥20) (HexAgon-HN)
🩺 Plain-English Summary (8th-Grade Level)
This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20.
Who can join: Review the eligibility criteria below.
Location: City of Hope Medical Center — Duarte, 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 (87 Sites)
Showing the first 25 of 87 sites.
- City of Hope Medical Center — Duarte, California
- Los Angeles Cancer Network (LACN) — Los Angeles, California
- UC Davis — Sacramento, California
- Medical Oncology Associates of San Diego — San Diego, California
- Sarcoma Oncology Center — Santa Monica, California
- ChristianaCare Health Services — Newark, Delaware
- University of Florida UF Health Cancer Center — Gainesville, Florida
- The Oncology Institute of Hope & Innovation — Miami, Florida
- Mid Florida Hematology and Oncology Center — Orange City, Florida
- Cleveland Clinic Florida, The Maroone Cancer Center — Weston, Florida
- University of Illinois Cancer Center — Chicago, Illinois
- Norton Cancer Institute — Louisville, Kentucky
- Massachusetts General Hospital — Boston, Massachusetts
- Karmanos Cancer Institute — Detroit, Michigan
- Washington University St. Louis — St Louis, Missouri
- Intermountain Health, St. Vincent Regional Hospital, Cancer Centers of Montana — Billings, Montana
- Oncology Hematology West, PC dba Nebraska Cancer Specialists — Omaha, Nebraska
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada
- Christus St. Vincent Regional Cancer Center — Santa Fe, New Mexico
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina
- Oklahoma University Stephenson Cancer Center — Oklahoma City, Oklahoma
- Oregon Health & Science University — Portland, Oregon
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
- CHRISTUS Spohn Cancer Center — Corpus Christi, Texas
- VCU Massey Comprehensive Cancer Center — Richmond, Virginia
📞 Contact the Study Coordinator
Phone: (800) 826-4673
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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 (HNSCC)
- SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma — Tucson, Arizona
- Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer — Pittsburgh, Pennsylvania
- [18F]-AraG PET Imaging in LA HNSCC — Indianapolis, Indiana
- A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma — Los Angeles, California
- Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors — Los Angeles, California
Explore by condition: All Head and Neck Squamous Cell Carcinoma (HNSCC) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.