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INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC
NCT06295731 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG INBRX-106
Study Locations (20)
California
- City of Hope Medical Center — Duarte
- Los Angeles Cancer Network (LACN) — Los Angeles
- Sutter Health — Sacramento
- UC Davis — Sacramento
- Medical Oncology Associates of San Diego — San Diego
- Sarcoma Oncology Center — Santa Monica
Florida
- University of Florida UF Health Cancer Center — Gainesville
- The Oncology Institute of Hope & Innovation — Miami
- Mid Florida Hematology and Oncology Center — Orange City
- Cleveland Clinic Florida, The Maroone Cancer Center — Weston
Delaware
- ChristianaCare Health Services — Newark
Illinois
- University of Illinois Cancer Center — Chicago
Kentucky
- Norton Cancer Institute — Louisville
Massachusetts
- Massachusetts General Hospital — Boston
Michigan
- Karmanos Cancer Institute — Detroit
Missouri
- Washington University St. Louis — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 410 participants |
| Start Date | 2024-05-14 |
| Est. Completion | 2029-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06295731
The ClinicalTrials.gov registry entry for NCT06295731 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 410 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Inhibrx Biosciences, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Head and Neck Squamous Cell Carcinoma (HNSCC) appearing as the primary indexed condition, and to 2 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06295731 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Delaware. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06295731 about?
NCT06295731 is a clinical study titled "INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC". 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 recurr...
What is the current status of trial NCT06295731?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 410 participants. The study started on 2024-05-14. Estimated completion is 2029-05.
What conditions does trial NCT06295731 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma (HNSCC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06295731?
The interventions under investigation include: Pembrolizumab (DRUG), INBRX-106 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06295731?
This trial is sponsored by Inhibrx Biosciences, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06295731 being conducted?
This trial has 20 study locations across California, Delaware, Florida, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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