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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: Recruiting 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.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. Summarized by treatment group. All on-study adverse events (AEs), treatment-related AEs, serious (S)AEs, and treatment-related SAEs will be tabulated using worst grade per NCI CTCAE version 4.0 criteria by system organ class and preferred term. On-study lab parameters including hematology, chemistry, liver function, and renal function will also be summarized using worst grade NCI CTC
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 |
What NCT04754321 shows while recruiting
NCT04754321 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 109-participant average among 9 other Recurrent Laryngeal Squamous Cell Carcinoma trials with a reported enrollment target (59% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Recurrent Laryngeal Squamous Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04754321's enrollment target sits among peer trials
45 7th of 9 higher than 3 of 9 other Recurrent Laryngeal Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Laryngeal 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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Testing the Addition of an Anti-cancer Drug, BAY 1895344, With Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer
ACTIVE NOT RECRUITING · Phase 1
-
Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma
RECRUITING · Phase 2
-
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
RECRUITING · Phase 3
-
Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer
RECRUITING · Phase 2
-
Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
ACTIVE NOT RECRUITING · Phase 3
-
Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer
ACTIVE NOT RECRUITING · Phase 2
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