Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
NCT07195734
This study is recruiting at 112 US sites in 24 states, according to its ClinicalTrials.gov record last updated .
Summary
This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel, or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage surgery followed by post operative radiation therapy and cisplatin for high risk patients, for the treatment of patients with PD-L1 positive head and neck squamous cell carcinoma that has come back and spread to nearby tissue or lymph nodes after a period of improvement (locally recurrent) or is persistent. Carboplatin is in a class of medications known as platinum-containing compounds.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Locally Recurrent Head and Neck Squamous Cell Carcinoma
- Locally Recurrent Hypopharyngeal Squamous Cell Carcinoma
- Locally Recurrent Laryngeal Squamous Cell Carcinoma
- Locally Recurrent Oral Cavity Squamous Cell Carcinoma
- Locally Recurrent Oropharyngeal Squamous Cell Carcinoma
- Stage II Laryngeal Cancer AJCC v8
- Stage II Lip and Oral Cavity Cancer AJCC v8
- Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage III Laryngeal Cancer AJCC v8
- Stage III Lip and Oral Cavity Cancer AJCC v8
- Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVA Laryngeal Cancer AJCC v8
- Stage IVA Lip and Oral Cavity Cancer AJCC v8
- Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVB Laryngeal Cancer AJCC v8
- Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- National Cancer Institute (NCI)
- Last updated on ClinicalTrials.gov
- October 14, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Arizona · 2
- Banner University Medical Center - Tucson · Tucson, AZ
- University of Arizona Cancer Center-North Campus · Tucson, AZ
California · 4
- USC / Norris Comprehensive Cancer Center · Los Angeles, CA
- Stanford Cancer Institute Palo Alto · Palo Alto, CA
- Sutter Medical Center Sacramento · Sacramento, CA
- University of California Davis Comprehensive Cancer Center · Sacramento, CA
Georgia · 2
- Emory Proton Therapy Center · Atlanta, GA
- Emory University Hospital Midtown · Atlanta, GA
Illinois · 16
- Northwestern University · Chicago, IL
- Rush MD Anderson Cancer Center · Chicago, IL
- Carle at The Riverfront · Danville, IL
- Northwestern Medicine Cancer Center Kishwaukee · DeKalb, IL
- Carle Physician Group-Effingham · Effingham, IL
- Northwestern Medicine Cancer Center Delnor · Geneva, IL
- Northwestern Medicine Glenview Outpatient Center · Glenview, IL
- Northwestern Medicine Grayslake Outpatient Center · Grayslake, IL
- Northwestern Medicine Lake Forest Hospital · Lake Forest, IL
- Rush MD Anderson Cancer Center at Rush Lisle · Lisle, IL
- Carle Physician Group-Mattoon/Charleston · Mattoon, IL
- Northwestern Medicine Oak Brook · Oak Brook, IL
- Northwestern Medicine Orland Park · Orland Park, IL
- Memorial Hospital East · Shiloh, IL
- Carle Cancer Center · Urbana, IL
- Northwestern Medicine Cancer Center Warrenville · Warrenville, IL
Iowa · 8
- UI Health Care Mission Cancer and Blood - Ankeny Clinic · Ankeny, IA
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic · Clive, IA
- Broadlawns Medical Center · Des Moines, IA
- Iowa Methodist Medical Center · Des Moines, IA
- Mercy Medical Center - Des Moines · Des Moines, IA
- UI Health Care Mission Cancer and Blood - Des Moines Clinic · Des Moines, IA
- UI Health Care Mission Cancer and Blood - Laurel Clinic · Des Moines, IA
- UI Health Care Mission Cancer and Blood - Waukee Clinic · Waukee, IA
Kansas · 3
- University of Kansas Cancer Center · Kansas City, KS
- University of Kansas Cancer Center-Overland Park · Overland Park, KS
- University of Kansas Hospital-Westwood Cancer Center · Westwood, KS
Louisiana · 3
- LSU Health Baton Rouge-North Clinic · Baton Rouge, LA
- Our Lady of The Lake · Baton Rouge, LA
- Our Lady of the Lake Physician Group · Baton Rouge, LA
Maine · 1
- Lafayette Family Cancer Center-EMMC · Brewer, ME
Michigan · 5
- University of Michigan Rogel Cancer Center · Ann Arbor, MI
- University of Michigan - Brighton Center for Specialty Care · Brighton, MI
- Henry Ford Hospital · Detroit, MI
- Wayne State University/Karmanos Cancer Institute · Detroit, MI
- Weisberg Cancer Treatment Center · Farmington Hills, MI
Mississippi · 1
- University of Mississippi Medical Center · Jackson, MS
Missouri · 8
- Siteman Cancer Center at Saint Peters Hospital · City of Saint Peters, MO
- Siteman Cancer Center at West County Hospital · Creve Coeur, MO
- University of Kansas Cancer Center - Briarcliff · Kansas City, MO
- University of Kansas Cancer Center - North · Kansas City, MO
- University of Kansas Cancer Center - Lee's Summit · Lee's Summit, MO
- Siteman Cancer Center at Christian Hospital · St Louis, MO
- Siteman Cancer Center-South County · St Louis, MO
- Washington University School of Medicine · St Louis, MO
Nebraska · 2
- Nebraska Cancer Specialists/Oncology Hematology West PC - MECC · Omaha, NE
- Nebraska Methodist Hospital · Omaha, NE
New Hampshire · 1
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center · Lebanon, NH
New Jersey · 7
- Cooper Hospital University Medical Center · Camden, NJ
- Jersey City Medical Center · Jersey City, NJ
- Cooperman Barnabas Medical Center · Livingston, NJ
- Monmouth Medical Center · Long Branch, NJ
- Rutgers Cancer Institute of New Jersey · New Brunswick, NJ
- Rutgers New Jersey Medical School · Newark, NJ
- Community Medical Center · Toms River, NJ
New York · 3
- University of Rochester · Rochester, NY
- Stony Brook University Medical Center · Stony Brook, NY
- Wilmot Cancer Institute at Webster · Webster, NY
North Carolina · 3
- UNC Lineberger Comprehensive Cancer Center · Chapel Hill, NC
- Carolinas Medical Center/Levine Cancer Institute · Charlotte, NC
- Atrium Health Cabarrus/LCI-Concord · Concord, NC
Ohio · 1
- ProMedica Flower Hospital · Sylvania, OH
Oklahoma · 1
- University of Oklahoma Health Sciences Center · Oklahoma City, OK
Oregon · 8
- Clackamas Radiation Oncology Center · Clackamas, OR
- Legacy Mount Hood Medical Center · Gresham, OR
- Providence Newberg Medical Center · Newberg, OR
- Providence Willamette Falls Medical Center · Oregon City, OR
- Legacy Good Samaritan Hospital and Medical Center · Portland, OR
- Providence Portland Medical Center · Portland, OR
- Providence Saint Vincent Medical Center · Portland, OR
- Legacy Meridian Park Hospital · Tualatin, OR
Pennsylvania · 20
- Saint Vincent Hospital · Erie, PA
- UPMC Hillman Cancer Center Erie · Erie, PA
- UPMC Cancer Center at UPMC Horizon · Farrell, PA
- IRMC Cancer Center · Indiana, PA
- Jefferson Hospital · Jefferson Hills, PA
- UPMC-Johnstown/John P. Murtha Regional Cancer Center · Johnstown, PA
- Forbes Hospital · Monroeville, PA
- UPMC Cancer Center - Monroeville · Monroeville, PA
- UPMC Hillman Cancer Center - Monroeville · Monroeville, PA
- Thomas Jefferson University Hospital · Philadelphia, PA
- Allegheny General Hospital · Pittsburgh, PA
- UPMC Hillman Cancer Center · Pittsburgh, PA
- UPMC-Saint Clair Hospital Cancer Center · Pittsburgh, PA
- UPMC-Saint Margaret · Pittsburgh, PA
- UPMC-Shadyside Hospital · Pittsburgh, PA
- UPMC Cancer Center at UPMC Northwest · Seneca, PA
- UPMC Cancer Center-Washington · Washington, PA
- UPMC Washington Hospital Radiation Oncology · Washington, PA
- Wexford Health and Wellness Pavilion · Wexford, PA
- Asplundh Cancer Pavilion · Willow Grove, PA
South Carolina · 1
- Medical University of South Carolina · Charleston, SC
Tennessee · 1
- Vanderbilt University/Ingram Cancer Center · Nashville, TN
Washington · 2
- Legacy Cancer Institute Medical Oncology and Day Treatment · Vancouver, WA
- Legacy Salmon Creek Hospital · Vancouver, WA
Wisconsin · 9
- University of Wisconsin Carbone Cancer Center - Johnson Creek · Johnson Creek, WI
- Gundersen Lutheran Medical Center · La Crosse, WI
- University of Wisconsin Carbone Cancer Center - Eastpark Medical Center · Madison, WI
- University of Wisconsin Carbone Cancer Center - University Hospital · Madison, WI
- Froedtert Menomonee Falls Hospital · Menomonee Falls, WI
- Medical College of Wisconsin · Milwaukee, WI
- Froedtert and MCW Moorland Reserve Health Center · New Berlin, WI
- Drexel Town Square Health Center · Oak Creek, WI
- Froedtert West Bend Hospital/Kraemer Cancer Center · West Bend, WI
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.