Cisplatin, Intensity-Modulated Radiation Therapy, and Pembrolizumab in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma
Public ClinicalTrials.gov record NCT02775812. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I and Expansion Cohort Study of Adjuvant Cisplatin, Intensity-Modulated Radiotherapy, and MK-3475 (Pembrolizumab) in High-Risk Head and Neck Squamous Cell Carcinoma (HNSCC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02775812
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 37 participants
Conditions and interventions
Conditions
- 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
- Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7
- Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7
- Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7
Interventions
- Cisplatin Drug
- Intensity-Modulated Radiation Therapy Radiation
- Laboratory Biomarker Analysis Other
- Pembrolizumab Biological
Drug · Radiation · Other + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 28, 2016 (Actual)
- Primary completion
- Dec 3, 2018 (Actual)
- Completion
- May 20, 2022 (Actual)
- Last update posted
- Jun 10, 2022
2016 – 2022
United States locations
- U.S. sites
- 69
- U.S. states
- 29
- U.S. cities
- 61
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner University Medical Center - Tucson | Tucson | Arizona | 85719 | — |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| Sutter Medical Center Sacramento | Sacramento | California | 95816 | — |
| University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| Penrose-Saint Francis Healthcare | Colorado Springs | Colorado | 80907 | — |
| Poudre Valley Hospital | Fort Collins | Colorado | 80524 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Helen F Graham Cancer Center | Newark | Delaware | 19713 | — |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | — |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida | 33146 | — |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | 33442 | — |
| University of Florida Health Science Center - Gainesville | Gainesville | Florida | 32610 | — |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | — |
| Grady Health System | Atlanta | Georgia | 30303 | — |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Rush - Copley Medical Center | Aurora | Illinois | 60504 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | — |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | — |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| Franciscan Health Indianapolis | Indianapolis | Indiana | 46237 | — |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | — |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | — |
| University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | 66210 | — |
| The James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky | 40202 | — |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | — |
| Henry Ford Cancer Institute-Downriver | Brownstown | Michigan | 48183 | — |
| Henry Ford Macomb Hospital-Clinton Township | Clinton Township | Michigan | 48038 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Sanford Joe Lueken Cancer Center | Bemidji | Minnesota | 56601 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| The University of Kansas Cancer Center-South | Kansas City | Missouri | 64131 | — |
| University of Kansas Cancer Center - North | Kansas City | Missouri | 64154 | — |
| University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | 64064 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87102 | — |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | — |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | — |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122 | — |
| Case Western Reserve University | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | 44111 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Cleveland Clinic Cancer Center Independence | Independence | Ohio | 44131 | — |
| Cleveland Clinic Cancer Center Mansfield | Mansfield | Ohio | 44906 | — |
| Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | 44124 | — |
| UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio | 44060 | — |
| North Coast Cancer Care | Sandusky | Ohio | 44870 | — |
| Cleveland Clinic Cancer Center Strongsville | Strongsville | Ohio | 44136 | — |
| Cleveland Clinic Wooster Family Health and Surgery Center | Wooster | Ohio | 44691 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Clackamas Radiation Oncology Center | Clackamas | Oregon | 97015 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Saint Luke's University Hospital-Bethlehem Campus | Bethlehem | Pennsylvania | 18015 | — |
| Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania | 19317 | — |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| UPMC-Shadyside Hospital | Pittsburgh | Pennsylvania | 15232 | — |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
| PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | 98225 | — |
| University of Washington Medical Center - Montlake | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02775812, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 10, 2022 · Synced Nov 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02775812 live on ClinicalTrials.gov.