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NCT03906526 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT03906526: Clinical Trial Phase 1 study, sponsored by Celgene.
NCT03906526 is a Phase 1 study that was terminated before completion, run by Celgene. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03906526, a Phase 1 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Tumor immune modulation will be evaluated by counting the number of tumor infiltration CD8+ T cells before and after treatment.
Interventions
- DRUG Nivolumab
- DRUG VTX-2337
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-07-03 |
| Est. Completion | 2022-01-24 |
| Phase | Phase 1 |
Why NCT03906526 stopped before completion
NCT03906526 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT03906526 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03906526 about?
NCT03906526 is a clinical study titled "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". 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...
What is the current status of trial NCT03906526?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2019-07-03. Estimated completion is 2022-01-24.
What interventions are being tested in trial NCT03906526?
The interventions under investigation include: Nivolumab (DRUG), VTX-2337 (DRUG).
Who is sponsoring clinical trial NCT03906526?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03906526's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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