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NCT05721755 · ClinicalTrials.gov registry record · Phase 3

Combining Radiation Therapy With Immunotherapy for the Treatment of Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase 3 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, sponsored by ECOG-ACRIN Cancer Research Group.

Active
Registry status
Phase 3
Development phase
290
Enrollment target
20
Study locations

NCT05721755 is a Phase 3 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 290 participants, above the 115-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (152% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT05721755, a Phase 3 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
290 participants
Enrollment target
20
Study locations

Study Summary

This phase III trial compares pembrolizumab with radiation therapy to pembrolizumab without radiation therapy (standard therapy) given after pembrolizumab plus chemotherapy for the treatment of patients with squamous cell carcinoma of the head and neck that has spread from where it first started (primary site) to other places in the body (metastatic). Pembrolizumab is a type of immunotherapy that stimulates the body's immune system to fight cancer cells. Pembrolizumab targets and blocks a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the T-cells to find and kill cancer cells. Radiation therapy uses high-powered rays to kill cancer cells. Giving radiation with pembrolizumab may be more effective at treating patients with metastatic head and neck cancer than the standard therapy of giving pembrolizumab alone.

Conditions Studied

Metastatic Head-and-neck Squamous-cell Carcinoma Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Metastatic Hypopharyngeal Squamous Cell Carcinoma Metastatic Laryngeal Squamous Cell Carcinoma Metastatic Oropharyngeal Squamous Cell Carcinoma Metastatic Oral Cavity Squamous Cell Carcinoma Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 Stage IV Hypopharyngeal Carcinoma AJCC v8 Stage IV Laryngeal Cancer AJCC v8 Stage IV Lip and Oral Cavity Cancer AJCC v8

Interventions

  • DRUG Carboplatin
  • PROCEDURE Computed Tomography
  • DRUG Cisplatin
  • DRUG Fluorouracil
  • PROCEDURE Magnetic Resonance Imaging

Study Locations (20)

Idaho

  • Saint Luke's Cancer Institute - Boise - Boise
  • Saint Luke's Cancer Institute - Fruitland - Fruitland
  • Saint Luke's Cancer Institute - Meridian - Meridian
  • Saint Luke's Cancer Institute - Nampa - Nampa
  • Saint Luke's Cancer Institute - Twin Falls - Twin Falls

Illinois

  • University of Illinois - Chicago
  • Carle at The Riverfront - Danville
  • Carle Physician Group-Effingham - Effingham
  • Carle Physician Group-Mattoon/Charleston - Mattoon
  • Carle Cancer Center - Urbana

Iowa

  • Mission Cancer and Blood - Ankeny - Ankeny
  • Mercy Hospital - Cedar Rapids
  • Oncology Associates at Mercy Medical Center - Cedar Rapids
  • Iowa Methodist Medical Center - Des Moines
  • Mission Cancer and Blood - Des Moines - Des Moines

Florida

  • Moffitt Cancer Center-International Plaza - Tampa
  • Moffitt Cancer Center - McKinley Campus - Tampa
  • Moffitt Cancer Center - Tampa

Georgia

  • Emory University Hospital Midtown - Atlanta

Minnesota

  • Sanford Joe Lueken Cancer Center - Bemidji

Trial Details

FieldValue
Enrollment Target 290 participants
Start Date 2023-06-08
Est. Completion 2030-03-31
Phase Phase 3

Sponsor

ECOG-ACRIN Cancer Research Group

75 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05721755

The ClinicalTrials.gov registry entry for NCT05721755 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 290 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 115-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (152% higher). The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 75 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Metastatic Head-and-neck Squamous-cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.

NCT05721755 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Idaho, Illinois, Iowa.

Frequently Asked Questions

What is clinical trial NCT05721755 about?

NCT05721755 is a clinical study titled "Combining Radiation Therapy With Immunotherapy for the Treatment of Metastatic Squamous Cell Carcinoma of the Head and Neck". This phase III trial compares pembrolizumab with radiation therapy to pembrolizumab without radiation therapy (standard therapy) given after pembrolizumab plus chemotherapy for the treatment of patients with squamous cell carcinoma of the head and neck that has spread from where it first started (pr...

What is the current status of trial NCT05721755?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 290 participants. The study started on 2023-06-08. Estimated completion is 2030-03-31.

What conditions does trial NCT05721755 study?

This clinical trial studies the following conditions: Metastatic Head-and-neck Squamous-cell Carcinoma, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Hypopharyngeal Squamous Cell Carcinoma, Metastatic Laryngeal Squamous Cell Carcinoma, Metastatic Oropharyngeal Squamous Cell Carcinoma.

What interventions are being tested in trial NCT05721755?

The interventions under investigation include: Carboplatin (DRUG), Computed Tomography (PROCEDURE), Cisplatin (DRUG), Fluorouracil (DRUG), Magnetic Resonance Imaging (PROCEDURE).

Who is sponsoring clinical trial NCT05721755?

This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05721755 being conducted?

This trial has 20 study locations across Florida, Georgia, Idaho, Illinois, Iowa. 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.