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NCT07552558 · ClinicalTrials.gov registry record · Phase 1
Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)
A Phase 1 study, sponsored by Washington University School of Medicine.
- Not yet
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT07552558: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.
NCT07552558 is a Phase 1 study that has not yet begun recruiting, run by Washington University School of Medicine. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07552558, a Phase 1 study, has not yet begun recruiting, sponsored by Washington University School of Medicine.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
The study is an open-label phase I/II clinical trial. The study will enroll patients to receive neoadjuvant SBRT plus 1 or 2 doses of neoadjuvant pembrolizumab with concurrent ficerafusp alfa (4 doses) prior to definitive surgical resection for high-risk, locoregionally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC). Approximately 6 weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection followed by SOC adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines. Adjuvant therapy is not part of this study and therefore is not dictated by study protocol.
Primary Outcome
The maximum tolerated dose (MTD) is defined as the highest dose level at which 0 or 1 patients of a cohort experience dose-limiting toxicity during the dose limiting toxicity (DLT) window. DLTs are defined in the protocol.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Ficerafusp alfa
- RADIATION Hypofractionated Stereotactic Body Radiotherapy (SBRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2026-06-30 |
| Est. Completion | 2033-08-31 |
| Phase | Phase 1 |
What is known before NCT07552558 opens enrollment
NCT07552558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT07552558 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07552558 about?
NCT07552558 is a clinical study titled "Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)". The study is an open-label phase I/II clinical trial. The study will enroll patients to receive neoadjuvant SBRT plus 1 or 2 doses of neoadjuvant pembrolizumab with concurrent ficerafusp alfa (4 doses) prior to definitive surgical resection for high-risk, locoregionally advanced HPV-negative head an...
What is the current status of trial NCT07552558?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2026-06-30. Estimated completion is 2033-08-31.
What interventions are being tested in trial NCT07552558?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Ficerafusp alfa (DRUG), Hypofractionated Stereotactic Body Radiotherapy (SBRT) (RADIATION).
Who is sponsoring clinical trial NCT07552558?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07552558's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 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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