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NCT04454489 · ClinicalTrials.gov registry record · Phase 2
Quad Shot Radiotherapy in Combination With Immune Checkpoint Inhibition
A Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT04454489: Completed Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by Wake Forest University Health Sciences.
NCT04454489 is a Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 21 participants, below the 126-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04454489, a Phase 2 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-arm, non-randomized pilot study to evaluate the efficacy and tolerability of combination quad-shot palliative radiotherapy with immunotherapy for advanced/recurrent/metastatic head and neck cancer.
Primary Outcome
Overall response will be measured according to RECIST 1.1 criteria to determine the percentage of participants with either a partial or complete response and the corresponding 95% Clopper-Pearson exact confidence interval. The best overall response is the best response recorded from the start of the treatment across all time points. COMPLETE RESPONSE: Disappearance (or decrease to the point at which measurement is not possible) of all target lesions. Any pathological lymph nodes (whether target
Conditions Studied
Interventions
- DRUG Pembrolizumab (immunotherapy)
- RADIATION Quad-shot palliative radiotherapy
Study Locations (1)
North Carolina
- Wake Forest Baptist Comprehensive Cancer Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2021-02-25 |
| Est. Completion | 2025-04-30 |
| Phase | Phase 2 |
What the finished NCT04454489 record still lists
NCT04454489 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 126-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (83% lower).
The record links to 6 conditions, with Metastatic Head-and-neck Squamous-cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab (immunotherapy) is the first listed.
NCT04454489 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04454489 about?
NCT04454489 is a clinical study titled "Quad Shot Radiotherapy in Combination With Immune Checkpoint Inhibition". This is a single-arm, non-randomized pilot study to evaluate the efficacy and tolerability of combination quad-shot palliative radiotherapy with immunotherapy for advanced/recurrent/metastatic head and neck cancer.
What is the current status of trial NCT04454489?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2021-02-25. Estimated completion is 2025-04-30.
What conditions does trial NCT04454489 study?
This clinical trial studies the following conditions: Metastatic Head-and-neck Squamous-cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma, Advanced Head and Neck Squamous Cell Carcinoma, Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck.
What interventions are being tested in trial NCT04454489?
The interventions under investigation include: Pembrolizumab (immunotherapy) (DRUG), Quad-shot palliative radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT04454489?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04454489 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04454489's enrollment target sits among peer trials
21 25th of 24 the lowest of 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Head-and-neck 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.
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