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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 is a Phase 1 study that was terminated before completion, run by Celgene. The registered enrollment target is 15 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03906526
The ClinicalTrials.gov registry entry for NCT03906526 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT03906526 reports 0 study locations.
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.
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