ClinicalTrials.gov record
Active, not recruiting Phase 2 Interventional

SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma

ClinicalTrials.gov ID: NCT03546582

Public ClinicalTrials.gov record NCT03546582. 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.

ClinicalTrials.gov public records Last synced May 4, 2026, 12:16 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

KEYSTROKE: A Randomized Phase II Study of Pembrolizumab (KEYTRUDA®) Plus Stereotactic Re-irradiation Versus SBRT Alone for Locoregionally Recurrent or Second Primary Head and Neck Carcinoma

Study identification

NCT ID
NCT03546582
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
RTOG Foundation, Inc.
Other
Enrollment
86 participants

Conditions and interventions

Interventions

  • Pembrolizumab Drug
  • Stereotactic Body Radiation Therapy (SBRT) Radiation

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
Nov 13, 2018
Primary completion
Jun 30, 2027
Completion
Jun 30, 2029
Last update posted
Jan 19, 2026

2018 – 2029

United States locations

U.S. sites
15
U.S. states
10
U.S. cities
15
Facility City State ZIP Site status
University of Arizona Cancer Center - North Campus Tucson Arizona 85719
Moffitt Cancer Center Tampa Florida 33612
Cleveland Clinic - Weston Weston Florida 33331
University of Louisville, James Graham Brown Cancer Center Louisville Kentucky 40202
Boston Medical Center Boston Massachusetts 02118
Washington University St. Louis St Louis Missouri 63110
Northwell Health Lake Success New York 11042
University of Cincinnati Cancer Center - UC Medical Center Cincinnati Ohio 45219
Cleveland Clinic Cleveland Ohio 44195
Ohio State University Columbus Ohio 43210
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania 17033
Fox Chase Cancer Center Philadelphia Pennsylvania 19111
University of Pittsburgh Medical Center Shadyside Pittsburgh Pennsylvania 15232
University of Texas Southwestern Dallas Texas 75390
Medical College of Wisconsin Milwaukee Wisconsin 53226

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 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03546582, 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 Jan 19, 2026 · Synced May 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03546582 live on ClinicalTrials.gov.

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