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: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (8 items).
Location: City of Hope Medical Center — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "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:
- Has primary tumor site (any histology) of nasopharynx or salivary glands or occult primary site.
- Has received prior systemic therapy (eg, prior chemo-, immune-, or biologic therapy) for locally advanced unresectable or metastatic HNSCC.
- Prior systemic therapy completed \>6 months prior to signing informed consent is allowed if given as part of multimodal treatment for locoregionally advanced disease with curative intent, and no PD/recurrence occurred within 6 months of its completion. Prior systemic immunotherapy in the locoregionally advanced disease with curative intent, including but not limited to anti-PD-(L)1 agents, is allowed if PD/recurrence occurred ≥12 months after its completion.
- Has clinically active central nervous system metastases and/or carcinomatous meningitis.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- Rapidly progressing disease or with features that may confer a high risk of tumor-associated hemorrhage or uncontrolled tumor pain.
- Current or history of immune-related disease that required systemic treatment in past 2 years, except for replacement therapy.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 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)
- [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
- 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
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.