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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 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 257-participant average among 13 other Head and Neck Squamous Cell Carcinoma (HNSCC) trials with a reported enrollment target (67% lower). The trial reports 18 study locations across 12 states.

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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).

Conditions Studied

Head and Neck Squamous Cell Carcinoma (HNSCC)

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

FieldValue
Enrollment Target 86 participants
Start Date 2018-11-14
Est. Completion 2029-07
Phase Phase 2

Sponsor

RTOG Foundation

6 total trials

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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, categorized as Phase 2. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 257-participant average among 13 other Head and Neck Squamous Cell Carcinoma (HNSCC) trials with a reported enrollment target (67% lower). The listed sponsor is RTOG Foundation, which has 6 total studies on file at ClinicalTrials.gov.

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 reports 18 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.