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NCT06295731 · ClinicalTrials.gov registry record · Phase 2
INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC
A Phase 2 study of Head and Neck Squamous Cell Carcinoma (HNSCC), sponsored by Inhibrx Biosciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 410
- Enrollment target
- 20
- Study locations
NCT06295731 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma (HNSCC) that is actively recruiting participants, run by Inhibrx Biosciences. The registered enrollment target is 410 participants, above the 232-participant average among 13 other Head and Neck Squamous Cell Carcinoma (HNSCC) trials with a reported enrollment target (77% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT06295731, a Phase 2 study of Head and Neck Squamous Cell Carcinoma (HNSCC), is actively recruiting participants, sponsored by Inhibrx Biosciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 410 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 410 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 232-participant average among 13 other Head and Neck Squamous Cell Carcinoma (HNSCC) trials with a reported enrollment target (77% higher). The listed sponsor is Inhibrx Biosciences, which has 6 total studies on file at ClinicalTrials.gov.
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.
NCT06295731 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Delaware.
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).
What interventions are being tested in trial NCT06295731?
The interventions under investigation include: Pembrolizumab (DRUG), INBRX-106 (DRUG).
Who is sponsoring clinical trial NCT06295731?
This trial is sponsored by Inhibrx Biosciences, which has 6 total clinical trials registered on ClinicalTrials.gov.
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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Related
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