Clinical Trial

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

Study acronym: KEYSTROKE
Active, Not Recruiting Phase 2
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Summary
This phase II trial with a safety run-in component will evaluate whether the addition of pembrolizumab to Stereotactic Body Radiation Therapy (SBRT) re-irradiation will improve the progression-free survival for patients with recurrent or new second primary Head and Neck Squamous Cell Carcinoma (HNSCC).
Protocol Amendment History 20 amendments
This ClinicalTrials.gov record has been amended 20 times since 2018-05-23; most recent amendment 2026-01-15.
Status change: Recruiting → Active, Not Recruiting 2026-01-15
Status change: Not Yet Recruiting → Recruiting 2018-11-16
Trial Details
NCT Number NCT03546582
Lead Sponsor RTOG Foundation, Inc.
Collaborators: Merck Sharp & Dohme LLC
Conditions Head and Neck Squamous Cell Carcinoma (HNSCC)
Enrollment 86 participants
Start Date 2018-11-14
Primary Completion 2027-07 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-01-20