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NCT03546582 · ClinicalTrials.gov registry record · Phase 2
SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma
A Phase 2 study of Head and Neck Squamous Cell Carcinoma (HNSCC), sponsored by RTOG Foundation.
- Active
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
- 18
- Study locations
NCT03546582: Active Phase 2 study of Head and Neck Squamous Cell Carcinoma (HNSCC), sponsored by RTOG Foundation.
NCT03546582 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma (HNSCC) that is active but no longer recruiting, run by RTOG Foundation. The registered enrollment target is 86 participants, below the 244-participant average among 14 other Head and Neck Squamous Cell Carcinoma (HNSCC) trials with a reported enrollment target (65% lower). The trial reports 18 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03546582, a Phase 2 study of Head and Neck Squamous Cell Carcinoma (HNSCC), is active but no longer recruiting, sponsored by RTOG Foundation.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
- 18
- Study locations
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).
Primary Outcome
The time from randomization to the first documented progressive disease (PD) per RECIST 1.1 or death due to any cause, whichever comes first.
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 |
What the registry record for NCT03546582 still lists
NCT03546582 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 244-participant average among 14 other Head and Neck Squamous Cell Carcinoma (HNSCC) trials with a reported enrollment target (65% lower).
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.
NCT03546582 lists 18 locations in 12 states (Ohio, Pennsylvania, Florida).
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).
What interventions are being tested in trial NCT03546582?
The interventions under investigation include: Pembrolizumab (DRUG), Stereotactic Body Radiation Therapy (SBRT) (RADIATION).
Who is sponsoring clinical trial NCT03546582?
This trial is sponsored by RTOG Foundation, which has 6 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Head and Neck Squamous Cell Carcinoma (HNSCC)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03546582's enrollment target sits among peer trials
86 9th of 14 higher than 6 of 14 other Head and Neck Squamous Cell Carcinoma (HNSCC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma (HNSCC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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