Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)
Public ClinicalTrials.gov record NCT03040999. 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 Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE-412)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS).
Study identification
- NCT ID
- NCT03040999
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 804 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Placebo Drug
- Cisplatin Drug
- Accelerated Fractionation (AFX) Radiotherapy Radiation
- Standard Fractionation (SFX) Radiotherapy Radiation
Biological · Drug · Radiation
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
- Apr 5, 2017 (Actual)
- Primary completion
- May 31, 2022 (Actual)
- Completion
- Aug 21, 2024 (Actual)
- Last update posted
- Feb 4, 2026
2017 – 2024
United States locations
- U.S. sites
- 24
- U.S. states
- 18
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Medical Center ( Site 0273) | Los Angeles | California | 90095 | — |
| University of California San Francisco ( Site 0274) | San Francisco | California | 94115 | — |
| St. Joseph Heritage Healthcare ( Site 0254) | Santa Rosa | California | 95403 | — |
| Smilow Cancer Hospital at Yale New Haven ( Site 0256) | New Haven | Connecticut | 06510 | — |
| Rush University Medical Center ( Site 0260) | Chicago | Illinois | 60612 | — |
| Indiana University ( Site 0264) | Indianapolis | Indiana | 46202 | — |
| Mary Bird Perkins Cancer Center at St. Tammany Parish Hospital ( Site 0281) | Baton Rouge | Louisiana | 70809 | — |
| University of Massachusetts Memorial Medical Center ( Site 0285) | Worcester | Massachusetts | 01655 | — |
| University of Michigan Hospital and Health Systems ( Site 0267) | Ann Arbor | Michigan | 48109 | — |
| Barbara Ann Karmanos Cancer Institute ( Site 0272) | Detroit | Michigan | 48201 | — |
| Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 0290) | Springfield | Missouri | 65804 | — |
| St. Vincent Healthcare Frontier Cancer Center ( Site 0286) | Billings | Montana | 59102 | — |
| Comprehensive Cancer Centers of Nevada ( Site 8004) | Las Vegas | Nevada | 89169 | — |
| University of Rochester - James P. Wilmot Cancer Center ( Site 0255) | Rochester | New York | 14642 | — |
| Oncology Hematology Care, Inc. ( Site 8003) | Cincinnati | Ohio | 45242 | — |
| Willamette Valley Cancer Institute and Research Center ( Site 8000) | Eugene | Oregon | 97401 | — |
| St. Luke's Cancer Center - Anderson ( Site 0251) | Easton | Pennsylvania | 18045 | — |
| St. Francis Hospital Cancer Center ( Site 1461) | Greenville | South Carolina | 29607 | — |
| Texas Oncology-Arlington North ( Site 8005) | Arlington | Texas | 76014 | — |
| Texas Oncology-Austin Central ( Site 8002) | Austin | Texas | 78731 | — |
| Texas Oncology PA ( Site 8001) | Longview | Texas | 75601 | — |
| University of Virginia Health System ( Site 0261) | Charlottesville | Virginia | 22908 | — |
| Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0269) | Seattle | Washington | 98109 | — |
| Medical Oncology Associates (Summit Cancer Centers) ( Site 0257) | Spokane | Washington | 99208 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 127 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03040999, 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 Feb 4, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03040999 live on ClinicalTrials.gov.