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NCT04754321 · ClinicalTrials.gov registry record · Phase 1
Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer
A Phase 1 study of Recurrent Laryngeal Squamous Cell Carcinoma and Head and Neck Carcinoma of Unknown Primary, sponsored by Ohio State University Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT04754321 is a Phase 1 study of Recurrent Laryngeal Squamous Cell Carcinoma and Head and Neck Carcinoma of Unknown Primary that is actively recruiting participants, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 45 participants, below the 109-participant average among 9 other Recurrent Laryngeal Squamous Cell Carcinoma trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04754321, a Phase 1 study of Recurrent Laryngeal Squamous Cell Carcinoma and Head and Neck Carcinoma of Unknown Primary, is actively recruiting participants, sponsored by Ohio State University Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial is to find out the possible side effects of pembrolizumab and radiation therapy before and during surgery in treating patients with head and neck squamous cell cancer that remains despite treatment (persistent) or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. Giving pembrolizumab and radiation therapy before and during surgery may kill more tumor cells.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Quality-of-Life Assessment
- RADIATION External Beam Radiation Therapy
- RADIATION Intraoperative Radiation Therapy
- PROCEDURE Salvage Surgery
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2022-05-12 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04754321
The ClinicalTrials.gov registry entry for NCT04754321 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 9 other Recurrent Laryngeal Squamous Cell Carcinoma trials with a reported enrollment target (59% lower). The listed sponsor is Ohio State University Comprehensive Cancer Center, which has 341 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Recurrent Laryngeal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04754321 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT04754321 about?
NCT04754321 is a clinical study titled "Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer". This phase I trial is to find out the possible side effects of pembrolizumab and radiation therapy before and during surgery in treating patients with head and neck squamous cell cancer that remains despite treatment (persistent) or has come back (recurrent). Immunotherapy with monoclonal antibodies...
What is the current status of trial NCT04754321?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2022-05-12. Estimated completion is 2026-12-31.
What conditions does trial NCT04754321 study?
This clinical trial studies the following conditions: Recurrent Laryngeal Squamous Cell Carcinoma, Head and Neck Carcinoma of Unknown Primary, Recurrent Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Head and Neck Squamous Cell Carcinoma, Resectable Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04754321?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Quality-of-Life Assessment (OTHER), External Beam Radiation Therapy (RADIATION), Intraoperative Radiation Therapy (RADIATION), Salvage Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT04754321?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04754321 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Recurrent Laryngeal Squamous Cell Carcinoma
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Head and Neck Carcinoma of Unknown Primary
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