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NCT04272333 · ClinicalTrials.gov registry record · Early Phase 1
Intratumoral Microdosing of Motolimod in HNSCC
A Early Phase 1 study, sponsored by Presage Biosciences.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 1
- Enrollment target
NCT04272333: Clinical Trial Early Phase 1 study, sponsored by Presage Biosciences.
NCT04272333 is a Early Phase 1 study that was terminated before completion, run by Presage Biosciences. The registered enrollment target is 1 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04272333, a Early Phase 1 study, was terminated before completion, sponsored by Presage Biosciences.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This is a multi-center, single arm, open-label, multi-agent, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of motolimod and motolimod combined with nivolumab when administered intratumorally in microdose quantities via the CIVO device in patients with head and neck squamous cell carcinoma (HNSCC). CIVO stands for comparative in vivo oncology.
Primary Outcome
Quantification of biomarker-positive and biomarker-negative cells will be performed within the tumor microenvironment around each of the injection sites of each resected patient sample by IHC and ISH. An aggregate analysis of this quantification may be done across patient samples to evaluate trends in tumor response. List of biomarkers evaluated may include biomarkers for cell death (e.g. cleaved caspase 3), T-cells (e.g. CD3, CD8/Granzyme B), and natural killer (NK)/myeloid cells (e.g. CD56/Gra
Interventions
- BIOLOGICAL Nivolumab
- DRUG Motolimod
- COMBINATION_PRODUCT Motolimod + Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-10-15 |
| Est. Completion | 2022-03-25 |
| Phase | Early Phase 1 |
Why NCT04272333 stopped before completion
NCT04272333 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT04272333 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04272333 about?
NCT04272333 is a clinical study titled "Intratumoral Microdosing of Motolimod in HNSCC". This is a multi-center, single arm, open-label, multi-agent, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of motolimod and motolimod combined with nivolumab when administered intratumorally in microdose quantities via th...
What is the current status of trial NCT04272333?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 1 participants. The study started on 2021-10-15. Estimated completion is 2022-03-25.
What interventions are being tested in trial NCT04272333?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Motolimod (DRUG), Motolimod + Nivolumab (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04272333?
This trial is sponsored by Presage Biosciences, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04272333's enrollment target sits among peer trials
1 1985th of 2000 the lowest of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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