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NCT05317000 · ClinicalTrials.gov registry record · Phase 2
5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC
A Phase 2 study of Squamous Cell Carcinoma of Head and Neck, sponsored by Barbara Burtness.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05317000: Recruiting Phase 2 study of Squamous Cell Carcinoma of Head and Neck, sponsored by Barbara Burtness.
NCT05317000 is a Phase 2 study of Squamous Cell Carcinoma of Head and Neck that is actively recruiting participants, run by Barbara Burtness. The registered enrollment target is 50 participants, below the 169-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05317000, a Phase 2 study of Squamous Cell Carcinoma of Head and Neck, is actively recruiting participants, sponsored by Barbara Burtness.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being done because both 5-azacytidine and nivolumab can influence the immune system's response to HPV-associated head and neck cancer, and we wish to evaluate whether taking 5-azacytidine will make HPV-associated head and neck cancer more sensitive to treatment with nivolumab. 5-Azacytidine (5-AZA) is a chemotherapy, and nivolumab is an immunotherapy. Both drugs are approved for use in the US by the Food and Drug Administration (FDA) for use in the treatment of different types of cancer, and nivolumab is approved for use in head and neck cancer that has previously been treated with chemotherapy. Because they are not approved to be used together in HPV-associated head and neck cancer, these drugs are considered experimental in this study. For this study, the drugs will be used either together or separately.
Primary Outcome
As assessed by the ir-PRC of Cottrell.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG 5-azacytidine
- DRUG Combination 5-azacytidine and nivolumab
Study Locations (1)
Connecticut
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-03-23 |
| Est. Completion | 2028-11-30 |
| Phase | Phase 2 |
What NCT05317000 shows while recruiting
NCT05317000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 169-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Squamous Cell Carcinoma of Head and Neck appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT05317000 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT05317000 about?
NCT05317000 is a clinical study titled "5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC". This study is being done because both 5-azacytidine and nivolumab can influence the immune system's response to HPV-associated head and neck cancer, and we wish to evaluate whether taking 5-azacytidine will make HPV-associated head and neck cancer more sensitive to treatment with nivolumab. 5-Azacy...
What is the current status of trial NCT05317000?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2023-03-23. Estimated completion is 2028-11-30.
What conditions does trial NCT05317000 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of Head and Neck.
What interventions are being tested in trial NCT05317000?
The interventions under investigation include: Nivolumab (DRUG), 5-azacytidine (DRUG), Combination 5-azacytidine and nivolumab (DRUG).
Who is sponsoring clinical trial NCT05317000?
This trial is sponsored by Barbara Burtness, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05317000 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05317000's enrollment target sits among peer trials
50 24th of 37 higher than 14 of 37 other Squamous Cell Carcinoma of Head and Neck trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Squamous Cell Carcinoma of Head and Neck 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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