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ACTIVE NOT RECRUITING Phase 3

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

NCT05721755 · View on ClinicalTrials.gov ↗

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.

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

52 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. It is categorized as Phase 3, 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 290 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT05721755 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Idaho, Illinois, Iowa. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05721755?

This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial