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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 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.

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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.

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

FieldValue
Enrollment Target 37 participants
Start Date 2016-11-28
Est. Completion 2022-05-20
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT02775812

The ClinicalTrials.gov registry entry for NCT02775812 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, 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 listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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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