INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC
Public ClinicalTrials.gov record NCT06295731. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06295731
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 410 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 14, 2024 (Actual)
- Primary completion
- May 2029 (Estimated)
- Completion
- May 2029 (Estimated)
- Last update posted
- May 8, 2026
2024 – 2029
United States locations
- U.S. sites
- 25
- U.S. states
- 18
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | — |
| Los Angeles Cancer Network (LACN) | Los Angeles | California | 91204 | — |
| UC Davis | Sacramento | California | 95817 | — |
| Medical Oncology Associates of San Diego | San Diego | California | 92123 | — |
| Sarcoma Oncology Center | Santa Monica | California | 90403 | — |
| ChristianaCare Health Services | Newark | Delaware | 19713 | — |
| University of Florida UF Health Cancer Center | Gainesville | Florida | 32608 | — |
| The Oncology Institute of Hope & Innovation | Miami | Florida | 33169 | — |
| Mid Florida Hematology and Oncology Center | Orange City | Florida | 32763 | — |
| Cleveland Clinic Florida, The Maroone Cancer Center | Weston | Florida | 33331 | — |
| University of Illinois Cancer Center | Chicago | Illinois | 60612 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Washington University St. Louis | St Louis | Missouri | 63110 | — |
| Intermountain Health, St. Vincent Regional Hospital, Cancer Centers of Montana | Billings | Montana | 59102 | — |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| Christus St. Vincent Regional Cancer Center | Santa Fe | New Mexico | 87505 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599-7305 | — |
| Oklahoma University Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| CHRISTUS Spohn Cancer Center | Corpus Christi | Texas | 78404 | — |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 62 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06295731, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 8, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06295731 live on ClinicalTrials.gov.