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NCT02775812 · ClinicalTrials.gov registry record · Phase 1
Cisplatin, Intensity-Modulated Radiation Therapy, and Pembrolizumab in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma
A Phase 1 study of Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 and Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 20
- Study locations
NCT02775812: Completed Phase 1 study of Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 and Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, sponsored by National Cancer Institute (NCI).
NCT02775812 is a Phase 1 study of Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 and Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7 that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 37 participants, below the 234-participant average among 5 other Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02775812, a Phase 1 study of Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 and Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of pembrolizumab when given together with cisplatin and intensity-modulated radiation therapy, in treating patients with stage III-IV squamous cell carcinoma of the head and neck. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Intensity-modulated radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab with cisplatin and intensity-modulated radiation therapy may work better in treating patients with squamous cell carcinoma of the head and neck.
Primary Outcome
Will be summarized using proportions for binary outcome per cohort.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Cisplatin
- OTHER Laboratory Biomarker Analysis
- RADIATION Intensity-Modulated Radiation Therapy
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- University of Florida Health Science Center - Gainesville - Gainesville
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
California
- UC San Diego Moores Cancer Center - La Jolla
- Cedars Sinai Medical Center - Los Angeles
- Sutter Medical Center Sacramento - Sacramento
Colorado
- University of Colorado Hospital - Aurora
- Penrose-Saint Francis Healthcare - Colorado Springs
- Poudre Valley Hospital - Fort Collins
Georgia
- Grady Health System - Atlanta
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
Illinois
- Rush - Copley Medical Center - Aurora
- Northwestern University - Chicago
- Rush University Medical Center - Chicago
Delaware
- Helen F Graham Cancer Center - Newark
- Christiana Care Health System-Christiana Hospital - Newark
Arizona
- Banner University Medical Center - Tucson - Tucson
Connecticut
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2016-11-28 |
| Est. Completion | 2022-05-20 |
| Phase | Phase 1 |
What the finished NCT02775812 record still lists
NCT02775812 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 234-participant average among 5 other Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 trials with a reported enrollment target (84% lower).
The record links to 10 conditions, with Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT02775812 names 20 study sites across 8 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT02775812 about?
NCT02775812 is a clinical study titled "Cisplatin, Intensity-Modulated Radiation Therapy, and Pembrolizumab in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma". This phase I trial studies the side effects and best dose of pembrolizumab when given together with cisplatin and intensity-modulated radiation therapy, in treating patients with stage III-IV squamous cell carcinoma of the head and neck. Monoclonal antibodies, such as pembrolizumab, may block tumor ...
What is the current status of trial NCT02775812?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2016-11-28. Estimated completion is 2022-05-20.
What conditions does trial NCT02775812 study?
This clinical trial studies the following conditions: Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7, Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7.
What interventions are being tested in trial NCT02775812?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Cisplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Intensity-Modulated Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT02775812?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02775812 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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