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NCT04852328 · ClinicalTrials.gov registry record · Phase 2
Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma
A Phase 2 study of Oropharyngeal Squamous Cell Carcinoma, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04852328: Recruiting Phase 2 study of Oropharyngeal Squamous Cell Carcinoma, sponsored by Washington University School of Medicine.
NCT04852328 is a Phase 2 study of Oropharyngeal Squamous Cell Carcinoma that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 30 participants, below the 214-participant average among 14 other Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04852328, a Phase 2 study of Oropharyngeal Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase 2 trial to assess the safety and tolerability of three schedules of CUE-101 administered in the neoadjuvant phase before standard of care (SOC) therapy to treatment naïve, HLA-A\*0201 positive patients with newly diagnosed, locally advanced HPV16+ oropharyngeal squamous-cell carcinoma (OPSCC). This is an exploratory trial of a limited sample size to confirm safety and to assess for pharmacodynamic signals of efficacy in each of three schedules of CUE-101. Safety assessments will be performed at baseline and after CUE-101 administration. To assess for efficacy, peripheral blood and tumor samples will be collected at baseline and after CUE-101 administration. Following CUE-101, patients will proceed with SOC therapy, as prescribed by the treating physician.
Conditions Studied
Interventions
- DRUG CUE-101
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-12-06 |
| Est. Completion | 2027-10-31 |
| Phase | Phase 2 |
What NCT04852328 shows while recruiting
NCT04852328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 214-participant average among 14 other Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Oropharyngeal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which CUE-101 is the first listed.
NCT04852328 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04852328 about?
NCT04852328 is a clinical study titled "Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma". This is a phase 2 trial to assess the safety and tolerability of three schedules of CUE-101 administered in the neoadjuvant phase before standard of care (SOC) therapy to treatment naïve, HLA-A\*0201 positive patients with newly diagnosed, locally advanced HPV16+ oropharyngeal squamous-cell carcinom...
What is the current status of trial NCT04852328?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2021-12-06. Estimated completion is 2027-10-31.
What conditions does trial NCT04852328 study?
This clinical trial studies the following conditions: Oropharyngeal Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04852328?
The interventions under investigation include: CUE-101 (DRUG).
Who is sponsoring clinical trial NCT04852328?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04852328 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04852328's enrollment target sits among peer trials
30 14th of 14 higher than 1 of 14 other Oropharyngeal Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oropharyngeal Squamous Cell Carcinoma 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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