Combining Radiation Therapy With Immunotherapy for the Treatment of Metastatic Squamous Cell Carcinoma of the Head and Neck
Public ClinicalTrials.gov record NCT05721755. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase III Randomized Trial of Immunotherapy With or Without Consolidative Radiotherapy for Oligometastatic Head and Neck Squamous Cell Carcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05721755
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 290 participants
Conditions and interventions
Conditions
- Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Metastatic Head and Neck Squamous Cell Carcinoma
- Metastatic Hypopharyngeal Squamous Cell Carcinoma
- Metastatic Laryngeal Squamous Cell Carcinoma
- Metastatic Oral Cavity Squamous Cell Carcinoma
- Metastatic Oropharyngeal 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
- Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Interventions
- Carboplatin Drug
- Cisplatin Drug
- Computed Tomography Procedure
- Fluorouracil Drug
- Magnetic Resonance Imaging Procedure
- Paclitaxel Drug
- Pembrolizumab Biological
- Positron Emission Tomography Procedure
- Quality-of-Life Assessment Other
- Radiation Therapy Radiation
Drug · Procedure · Biological + 2 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 8, 2023 (Actual)
- Primary completion
- Mar 31, 2029 (Estimated)
- Completion
- Mar 31, 2030 (Estimated)
- Last update posted
- Sep 14, 2026
2023 – 2030
United States locations
- U.S. sites
- 51
- U.S. states
- 17
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Moffitt Cancer Center-International Plaza | Tampa | Florida | 33607 | — |
| Moffitt Cancer Center - McKinley Campus | Tampa | Florida | 33612 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | — |
| Saint Luke's Cancer Institute - Fruitland | Fruitland | Idaho | 83619 | — |
| Saint Luke's Cancer Institute - Meridian | Meridian | Idaho | 83642 | — |
| Saint Luke's Cancer Institute - Nampa | Nampa | Idaho | 83686 | — |
| Saint Luke's Cancer Institute - Twin Falls | Twin Falls | Idaho | 83301 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| Carle at The Riverfront | Danville | Illinois | 61832 | — |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | — |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | 61938 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| Mission Cancer and Blood - Ankeny | Ankeny | Iowa | 50023 | — |
| Mercy Hospital | Cedar Rapids | Iowa | 52403 | — |
| Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | — |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | — |
| Mission Cancer and Blood - Des Moines | Des Moines | Iowa | 50309 | — |
| Sanford Joe Lueken Cancer Center | Bemidji | Minnesota | 56601 | — |
| Freeman Health System | Joplin | Missouri | 64804 | — |
| Sands Cancer Center | Canandiaqua | New York | 14424 | — |
| Wilmot Cancer Institute Radiation Oncology at Greece | Rochester | New York | 14606 | — |
| Highland Hospital | Rochester | New York | 14620 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| Wilmot Cancer Institute at Webster | Webster | New York | 14580 | — |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | — |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | — |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122 | — |
| UH Seidman Cancer Center at UH Avon Health Center | Avon | Ohio | 44011 | — |
| Case Western Reserve University | Cleveland | Ohio | 44106 | — |
| UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio | 44060 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Providence Newberg Medical Center | Newberg | Oregon | 97132 | — |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota | 57104 | — |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | — |
| VCU Massey Cancer Center at Stony Point | Richmond | Virginia | 23235 | — |
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | — |
| Langlade Hospital and Cancer Center | Antigo | Wisconsin | 54409 | — |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | — |
| ProHealth D N Greenwald Center | Mukwonago | Wisconsin | 53149 | — |
| ProHealth Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin | 53066 | — |
| Ascension Saint Mary's Hospital | Rhinelander | Wisconsin | 54501 | — |
| Ascension Saint Michael's Hospital | Stevens Point | Wisconsin | 54481 | — |
| UW Cancer Center at ProHealth Care | Waukesha | Wisconsin | 53188 | — |
| Aspirus Regional Cancer Center | Wausau | Wisconsin | 54401 | — |
| Aspirus Cancer Care - Wisconsin Rapids | Wisconsin Rapids | Wisconsin | 54494 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05721755, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 14, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05721755 live on ClinicalTrials.gov.