Clinical trialNCT05721755Active, not recruitingPhase 3Interventional

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

SponsorECOG-ACRIN Cancer Research GroupEnrollment290Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Metastatic Head and Neck Squamous Cell CarcinomaMetastatic Hypopharyngeal Squamous Cell CarcinomaMetastatic Laryngeal Squamous Cell CarcinomaMetastatic Oral Cavity Squamous Cell CarcinomaMetastatic Oropharyngeal Squamous Cell Carcinoma+5 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

David J Sher
ECOG-ACRIN Cancer Research Group
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

51 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Moffitt Cancer Center
Tampa, Florida, United States
Moffitt Cancer Center - Mckinley Campus
Tampa, Florida, United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Saint Luke'S Cancer Institute - Boise
Boise, Idaho, United States
Saint Luke'S Cancer Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke'S Cancer Institute - Meridian
Meridian, Idaho, United States
Saint Luke'S Cancer Institute - Nampa
Nampa, Idaho, United States
Saint Luke'S Cancer Institute - Twin Falls
Twin Falls, Idaho, United States
University of Illinois
Chicago, Illinois, United States
Carle at the Riverfront
Danville, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Carle Physician Group-Mattoon/charleston
Mattoon, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Mission Cancer and Blood - Ankeny
Ankeny, Iowa, United States
Mercy Hospital
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Mission Cancer and Blood - Des Moines
Des Moines, Iowa, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States
Freeman Health System
Joplin, Missouri, United States
Sands Cancer Center
Canandiaqua, New York, United States
Highland Hospital
Rochester, New York, United States
University of Rochester
Rochester, New York, United States
Wilmot Cancer Institute Radiation Oncology at Greece
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Wilmot Cancer Institute at Webster
Webster, New York, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Uh Seidman Cancer Center at Uh Avon Health Center
Avon, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Uh Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford Usd Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States

11 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Carboplatin →Cisplatin →Fluorouracil →Paclitaxel →Pembrolizumab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 8 Jun 2023
Primary completion: 31 Mar 2029
Completion: 31 Mar 2030
Last update posted: 10 Jul 2026
Registered enrollment: 290
Registry id: NCT05721755

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.