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NCT04318717 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma
A Phase 2 study of Mucosal Melanoma of the Head and Neck, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT04318717: Recruiting Phase 2 study of Mucosal Melanoma of the Head and Neck, sponsored by Washington University School of Medicine.
NCT04318717 is a Phase 2 study of Mucosal Melanoma of the Head and Neck that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 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
NCT04318717, a Phase 2 study of Mucosal Melanoma of the Head and Neck, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, single center, one cohort, non-randomized, phase II study. The aim is to evaluate the efficacy and safety of the combination of hypofractionated radiotherapy (HRT) and pembrolizumab on local tumor control in mucosal melanoma patients. Treatment effect will be compared with historical radiation therapy-alone control data.
Primary Outcome
Tumor control rate is defined as the percentage of subjects at 12 months who are free of local recurrence, regional recurrence, distant recurrence, second primary cancer, or death.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- RADIATION Hypofractionated radiation therapy
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2020-05-29 |
| Est. Completion | 2032-07-31 |
| Phase | Phase 2 |
What NCT04318717 shows while recruiting
NCT04318717 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Mucosal Melanoma of the Head and Neck appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04318717 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04318717 about?
NCT04318717 is a clinical study titled "Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma". This is an open-label, single center, one cohort, non-randomized, phase II study. The aim is to evaluate the efficacy and safety of the combination of hypofractionated radiotherapy (HRT) and pembrolizumab on local tumor control in mucosal melanoma patients. Treatment effect will be compared with his...
What is the current status of trial NCT04318717?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2020-05-29. Estimated completion is 2032-07-31.
What conditions does trial NCT04318717 study?
This clinical trial studies the following conditions: Mucosal Melanoma of the Head and Neck.
What interventions are being tested in trial NCT04318717?
The interventions under investigation include: Pembrolizumab (DRUG), Hypofractionated radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT04318717?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04318717 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
How this trial's enrollment target compares
Where NCT04318717's enrollment target sits among peer trials
19 1895th of 2000 higher than 103 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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