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SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma
NCT03546582 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DRUG Pembrolizumab
- RADIATION Stereotactic Body Radiation Therapy (SBRT)
Study Locations (18)
Ohio
- University of Cincinnati Cancer Center - UC Medical Center — Cincinnati
- Cleveland Clinic — Cleveland
- Ohio State University — Columbus
Pennsylvania
- Penn State Milton S. Hershey Medical Center — Hershey
- Fox Chase Cancer Center — Philadelphia
- University of Pittsburgh Medical Center Shadyside — Pittsburgh
Florida
- Moffitt Cancer Center — Tampa
- Cleveland Clinic - Weston — Weston
Quebec
- Centre Hospitalier de l'université de Montréal — Montreal
- McGill University — Montreal
Arizona
- University of Arizona Cancer Center - North Campus — Tucson
Kentucky
- University of Louisville, James Graham Brown Cancer Center — Louisville
Massachusetts
- Boston Medical Center — Boston
Missouri
- Washington University St. Louis — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2018-11-14 |
| Est. Completion | 2029-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03546582
The ClinicalTrials.gov registry entry for NCT03546582 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is RTOG Foundation, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Head and Neck Squamous Cell Carcinoma (HNSCC) appearing as the primary indexed condition, and to 2 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03546582 reports 18 study locations spanning 12 distinct geographic areas — top geographies include Ohio, Pennsylvania, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03546582 about?
NCT03546582 is a clinical study titled "SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma". 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 (HNSC...
What is the current status of trial NCT03546582?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2018-11-14. Estimated completion is 2029-07.
What conditions does trial NCT03546582 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma (HNSCC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03546582?
The interventions under investigation include: Pembrolizumab (DRUG), Stereotactic Body Radiation Therapy (SBRT) (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03546582?
This trial is sponsored by RTOG Foundation, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03546582 being conducted?
This trial has 18 study locations across Arizona, Florida, Kentucky, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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