New combo therapy aims to stop head and neck cancer from returning

NCT ID NCT07195734

Recruiting now Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Aug 12, 2026 · Updated 16 times

Summary

This phase II trial is testing whether adding chemotherapy or chemo-immunotherapy before standard salvage surgery can improve outcomes for patients with PD-L1 positive head and neck cancer that has come back. About 180 participants will receive either carboplatin and paclitaxel, or those drugs plus the immunotherapy cemiplimab, before surgery. The goal is to see if these combinations help keep the cancer from returning longer than surgery alone.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Carboplatin, paclitaxel, and cemiplimab (a monoclonal antibody)
What this could lead to: If successful, this approach could help control recurrent head and neck cancer better than surgery alone, potentially delaying or preventing the cancer from coming back.
What could go wrong: This is an early phase II trial with only 180 participants, so results may not apply to everyone. Adding chemotherapy and immunotherapy before surgery also increases the risk of side effects like fatigue, nausea, and immune-related reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

carcinoma head and neck squamous cell carcinoma hypopharynx squamous cell carcinoma laryngeal carcinoma laryngeal neoplasm laryngeal squamous cell carcinoma larynx cancer lip and oral cavity carcinoma lip and oral cavity squamous cell carcinoma Mouth Neoplasms oral cavity squamous cell carcinoma oropharyngeal carcinoma oropharynx cancer oropharynx squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

Contacts and locations

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Locations

Allegheny General Hospital
RECRUITING

Pittsburgh, Pennsylvania, 15212, United States
Asplundh Cancer Pavilion
RECRUITING

Willow Grove, Pennsylvania, 19090, United States

Contact Email: •••••@•••••
Atrium Health Cabarrus/LCI-Concord
RECRUITING

Concord, North Carolina, 28025, United States
Banner University Medical Center - Tucson
RECRUITING

Tucson, Arizona, 85719, United States
Broadlawns Medical Center
RECRUITING

Des Moines, Iowa, 50314, United States
Carolinas Medical Center/Levine Cancer Institute
RECRUITING

Charlotte, North Carolina, 28203, United States
Clackamas Radiation Oncology Center
RECRUITING

Clackamas, Oregon, 97015, United States

Contact Email: •••••@•••••
Community Medical Center
RECRUITING

Toms River, New Jersey, 08755, United States
Cooper Hospital University Medical Center
RECRUITING

Camden, New Jersey, 08103, United States
Cooperman Barnabas Medical Center
RECRUITING

Livingston, New Jersey, 07039, United States
Drexel Town Square Health Center
RECRUITING

Oak Creek, Wisconsin, 53154, United States
Emory Proton Therapy Center
RECRUITING

Atlanta, Georgia, 30308, United States
Emory University Hospital Midtown
RECRUITING

Atlanta, Georgia, 30308, United States
Forbes Hospital
RECRUITING

Monroeville, Pennsylvania, 15146, United States
Froedtert Menomonee Falls Hospital
RECRUITING

Menomonee Falls, Wisconsin, 53051, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
RECRUITING

West Bend, Wisconsin, 53095, United States
Froedtert and MCW Moorland Reserve Health Center
RECRUITING

New Berlin, Wisconsin, 53151, United States
Henry Ford Hospital
RECRUITING

Detroit, Michigan, 48202, United States

Contact Email: •••••@•••••
IRMC Cancer Center
RECRUITING

Indiana, Pennsylvania, 15701, United States
Iowa Methodist Medical Center
RECRUITING

Des Moines, Iowa, 50309, United States
Jefferson Hospital
RECRUITING

Jefferson Hills, Pennsylvania, 15025, United States
Jersey City Medical Center
RECRUITING

Jersey City, New Jersey, 07302, United States
LSU Health Baton Rouge-North Clinic
RECRUITING

Baton Rouge, Louisiana, 70805, United States

Contact Email: •••••@•••••
Lafayette Family Cancer Center-EMMC
RECRUITING

Brewer, Maine, 04412, United States
Legacy Cancer Institute Medical Oncology and Day Treatment
RECRUITING

Vancouver, Washington, 98684, United States

Contact Email: •••••@•••••
Legacy Good Samaritan Hospital and Medical Center
RECRUITING

Portland, Oregon, 97210, United States

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Legacy Meridian Park Hospital
RECRUITING

Tualatin, Oregon, 97062, United States
Legacy Mount Hood Medical Center
RECRUITING

Gresham, Oregon, 97030, United States
Legacy Salmon Creek Hospital
RECRUITING

Vancouver, Washington, 98686, United States
Medical College of Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Medical University of South Carolina
RECRUITING

Charleston, South Carolina, 29425, United States
Memorial Hospital East
RECRUITING

Shiloh, Illinois, 62269, United States
Mercy Medical Center - Des Moines
RECRUITING

Des Moines, Iowa, 50314, United States
Methodist Jennie Edmundson Hospital
SUSPENDED

Council Bluffs, Iowa, 51503, United States
Monmouth Medical Center
RECRUITING

Long Branch, New Jersey, 07740, United States
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
RECRUITING

Omaha, Nebraska, 68114, United States
Nebraska Methodist Hospital
RECRUITING

Omaha, Nebraska, 68114, United States
Northwestern Medicine Cancer Center Delnor
RECRUITING

Geneva, Illinois, 60134, United States
Northwestern Medicine Cancer Center Kishwaukee
RECRUITING

DeKalb, Illinois, 60115, United States
Northwestern Medicine Cancer Center Warrenville
RECRUITING

Warrenville, Illinois, 60555, United States
Northwestern Medicine Glenview Outpatient Center
RECRUITING

Glenview, Illinois, 60026, United States
Northwestern Medicine Grayslake Outpatient Center
RECRUITING

Grayslake, Illinois, 60030, United States
Northwestern Medicine Lake Forest Hospital
RECRUITING

Lake Forest, Illinois, 60045, United States

Contact Email: •••••@•••••
Northwestern Medicine Oak Brook
RECRUITING

Oak Brook, Illinois, 60523, United States
Northwestern Medicine Orland Park
RECRUITING

Orland Park, Illinois, 60462, United States
Northwestern University
RECRUITING

Chicago, Illinois, 60611, United States

Contact Email: •••••@•••••
Our Lady of the Lake Physician Group
RECRUITING

Baton Rouge, Louisiana, 70808, United States

Contact Email: •••••@•••••
ProMedica Flower Hospital
RECRUITING

Sylvania, Ohio, 43560, United States

Contact Email: •••••@•••••
Providence Newberg Medical Center
RECRUITING

Newberg, Oregon, 97132, United States

Contact Email: •••••@•••••
Providence Portland Medical Center
RECRUITING

Portland, Oregon, 97213, United States

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Providence Saint Vincent Medical Center
RECRUITING

Portland, Oregon, 97225, United States

Contact Email: •••••@•••••
Providence Willamette Falls Medical Center
RECRUITING

Oregon City, Oregon, 97045, United States

Contact Email: •••••@•••••
Rush MD Anderson Cancer Center
RECRUITING

Chicago, Illinois, 60612, United States

Contact Email: •••••@•••••
Rush MD Anderson Cancer Center at Rush Lisle
RECRUITING

Lisle, Illinois, 60532, United States

Contact Email: •••••@•••••
Rutgers Cancer Institute of New Jersey
RECRUITING

New Brunswick, New Jersey, 08903, United States
Rutgers New Jersey Medical School
RECRUITING

Newark, New Jersey, 07101, United States
Saint Vincent Hospital
RECRUITING

Erie, Pennsylvania, 16544, United States
Siteman Cancer Center at Christian Hospital
RECRUITING

St Louis, Missouri, 63136, United States

Contact Email: •••••@•••••
Siteman Cancer Center at Saint Peters Hospital
RECRUITING

City of Saint Peters, Missouri, 63376, United States

Contact Email: •••••@•••••
Siteman Cancer Center at West County Hospital
RECRUITING

Creve Coeur, Missouri, 63141, United States

Contact Email: •••••@•••••
Siteman Cancer Center-South County
RECRUITING

St Louis, Missouri, 63129, United States

Contact Email: •••••@•••••
Stony Brook University Medical Center
RECRUITING

Stony Brook, New York, 11794, United States
Sutter Medical Center Sacramento
RECRUITING

Sacramento, California, 95816, United States

Contact Email: •••••@•••••
Thomas Jefferson University Hospital
RECRUITING

Philadelphia, Pennsylvania, 19107, United States

Contact Email: •••••@•••••
UI Health Care Mission Cancer and Blood - Ankeny Clinic
RECRUITING

Ankeny, Iowa, 50023, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
RECRUITING

Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
RECRUITING

Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
RECRUITING

Waukee, Iowa, 50263, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
RECRUITING

Clive, Iowa, 50325, United States
UNC Lineberger Comprehensive Cancer Center
RECRUITING

Chapel Hill, North Carolina, 27599, United States

Contact Email: •••••@•••••
UPMC Cancer Center - Monroeville
RECRUITING

Monroeville, Pennsylvania, 15146, United States
UPMC Cancer Center at UPMC Horizon
RECRUITING

Farrell, Pennsylvania, 16121, United States
UPMC Cancer Center at UPMC Northwest
RECRUITING

Seneca, Pennsylvania, 16346, United States
UPMC Cancer Center-Washington
RECRUITING

Washington, Pennsylvania, 15301, United States
UPMC Hillman Cancer Center
RECRUITING

Pittsburgh, Pennsylvania, 15232, United States
UPMC Hillman Cancer Center - Monroeville
RECRUITING

Monroeville, Pennsylvania, 15146, United States

Contact Email: •••••@•••••
UPMC Hillman Cancer Center Erie
RECRUITING

Erie, Pennsylvania, 16505, United States

Contact Email: •••••@•••••
UPMC Washington Hospital Radiation Oncology
RECRUITING

Washington, Pennsylvania, 15301, United States

Contact Email: •••••@•••••
UPMC-Johnstown/John P. Murtha Regional Cancer Center
RECRUITING

Johnstown, Pennsylvania, 15901, United States
UPMC-Saint Clair Hospital Cancer Center
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Pittsburgh, Pennsylvania, 15243, United States
UPMC-Saint Margaret
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Pittsburgh, Pennsylvania, 15215, United States
UPMC-Shadyside Hospital
RECRUITING

Pittsburgh, Pennsylvania, 15232, United States
USC / Norris Comprehensive Cancer Center
RECRUITING

Los Angeles, California, 90033, United States
University of Arizona Cancer Center-North Campus
RECRUITING

Tucson, Arizona, 85719, United States
University of California Davis Comprehensive Cancer Center
RECRUITING

Sacramento, California, 95817, United States
University of Kansas Cancer Center
RECRUITING

Kansas City, Kansas, 66160, United States
University of Kansas Cancer Center - Briarcliff
RECRUITING

Kansas City, Missouri, 64116, United States
University of Kansas Cancer Center - Lee's Summit
RECRUITING

Lee's Summit, Missouri, 64064, United States
University of Kansas Cancer Center - North
RECRUITING

Kansas City, Missouri, 64154, United States
University of Kansas Cancer Center-Overland Park
RECRUITING

Overland Park, Kansas, 66210, United States
University of Kansas Hospital-Westwood Cancer Center
RECRUITING

Westwood, Kansas, 66205, United States
University of Michigan - Brighton Center for Specialty Care
RECRUITING

Brighton, Michigan, 48116, United States
University of Michigan Rogel Cancer Center
RECRUITING

Ann Arbor, Michigan, 48109, United States

Contact Email: •••••@•••••
University of Oklahoma Health Sciences Center
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
RECRUITING

Madison, Wisconsin, 53718, United States

Contact Email: •••••@•••••
University of Wisconsin Carbone Cancer Center - Johnson Creek
RECRUITING

Johnson Creek, Wisconsin, 53038, United States

Contact Email: •••••@•••••
University of Wisconsin Carbone Cancer Center - University Hospital
RECRUITING

Madison, Wisconsin, 53792, United States

Contact Email: •••••@•••••
Vanderbilt University/Ingram Cancer Center
RECRUITING

Nashville, Tennessee, 37232, United States
Washington University School of Medicine
RECRUITING

St Louis, Missouri, 63110, United States

Contact Email: •••••@•••••
Wayne State University/Karmanos Cancer Institute
RECRUITING

Detroit, Michigan, 48201, United States

Contact Email: •••••@•••••
Weisberg Cancer Treatment Center
RECRUITING

Farmington Hills, Michigan, 48334, United States

Contact Email: •••••@•••••
Wexford Health and Wellness Pavilion
RECRUITING

Wexford, Pennsylvania, 15090, United States

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