A Study to Evaluate Immune Biomarker Modulation in Response to VTX-2337 in Combination With an Anti- PD-1 Inhibitor in Head and Neck Cancer
Public ClinicalTrials.gov record NCT03906526. 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 1b Multicenter Pre-Surgical Study to Evaluate Immune Biomarker Modulation in Response to Motolimod (VTX-2337) in Combination With Nivolumab in Subjects With Resectable Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open label, Phase 1b pre-operative window of opportunity biomarker trial to analyze the combination of intravenous (IV) anti-PD-1 inhibitor, nivolumab, given along with toll-like receptor 8 (TLR 8) agonist motolimod delivered either subcutaneously (SC) or by intratumoral injection (IT) in subjects with squamous cell carcinoma of the head and neck (SCCHN). Subjects with previously untreated, resectable SCCHN, will be recruited onto this trial and will initially undergo pre-treatment diagnostic imaging and biological sample collection. These subjects will undergo pre-operative study treatment for a 3 to 4-week period prior to a scheduled surgical resection.
Study identification
- NCT ID
- NCT03906526
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 15 participants
Conditions and interventions
Conditions
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
- Jul 3, 2019 (Actual)
- Primary completion
- Jan 24, 2022 (Actual)
- Completion
- Jan 24, 2022 (Actual)
- Last update posted
- Feb 24, 2023
2019 – 2022
United States locations
- U.S. sites
- 12
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 112 | Birmingham | Alabama | 35294-3300 | — |
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-3300 | — |
| Boston University | Boston | Massachusetts | 02215 | — |
| Local Institution - 116 | Boston | Massachusetts | 02215 | — |
| Local Institution - 102 | St Louis | Missouri | 63110 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267-0501 | — |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Local Institution - 101 | Pittsburgh | Pennsylvania | 15232 | — |
| University of Pittsburgh Medical Center Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Local Institution - 103 | Sioux Falls | South Dakota | 57104-8805 | — |
| Sanford Cancer Center | Sioux Falls | South Dakota | 57104-8805 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03906526, 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 Feb 24, 2023 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03906526 live on ClinicalTrials.gov.