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Recruiting Phase 2 Interventional

Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer

ClinicalTrials.gov ID: NCT07195734

Public ClinicalTrials.gov record NCT07195734. 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.

ClinicalTrials.gov public records Last synced Oct 16, 2026, 5:26 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase II Randomized Trial of Neoadjuvant Chemotherapy or Chemo-Immunotherapy in Patients With Recurrent/Persistent PD-L1 Enriched Squamous Cell Carcinoma of the Head and Neck Undergoing Salvage Surgery (NEOPOLIS)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Salvage surgery is surgery that takes place to remove tumor tissue after a failure of other treatment. High risk patients also receive radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding chemotherapy or chemo-immunotherapy to standard salvage surgery may kill more tumor cells than salvage surgery alone in patients with PD-L1 positive locally recurrent or persistent head and neck squamous cell carcinoma.

Study identification

NCT ID
NCT07195734
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Enrollment
180 participants

Conditions and interventions

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
Apr 24, 2026 (Actual)
Primary completion
Feb 1, 2033 (Estimated)
Completion
Feb 1, 2033 (Estimated)
Last update posted
Oct 14, 2026

2026 – 2033

United States locations

U.S. sites
113
U.S. states
24
U.S. cities
86
Facility City State ZIP Site status
Banner University Medical Center - Tucson Tucson Arizona 85719 Recruiting
University of Arizona Cancer Center-North Campus Tucson Arizona 85719 Recruiting
USC / Norris Comprehensive Cancer Center Los Angeles California 90033 Recruiting
Stanford Cancer Institute Palo Alto Palo Alto California 94304 Recruiting
Sutter Medical Center Sacramento Sacramento California 95816 Recruiting
University of California Davis Comprehensive Cancer Center Sacramento California 95817 Recruiting
Emory Proton Therapy Center Atlanta Georgia 30308 Recruiting
Emory University Hospital Midtown Atlanta Georgia 30308 Recruiting
Northwestern University Chicago Illinois 60611 Recruiting
Rush MD Anderson Cancer Center Chicago Illinois 60612 Recruiting
Carle at The Riverfront Danville Illinois 61832 Recruiting
Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois 60115 Recruiting
Carle Physician Group-Effingham Effingham Illinois 62401 Recruiting
Northwestern Medicine Cancer Center Delnor Geneva Illinois 60134 Recruiting
Northwestern Medicine Glenview Outpatient Center Glenview Illinois 60026 Recruiting
Northwestern Medicine Grayslake Outpatient Center Grayslake Illinois 60030 Recruiting
Northwestern Medicine Lake Forest Hospital Lake Forest Illinois 60045 Recruiting
Rush MD Anderson Cancer Center at Rush Lisle Lisle Illinois 60532 Recruiting
Carle Physician Group-Mattoon/Charleston Mattoon Illinois 61938 Recruiting
Northwestern Medicine Oak Brook Oak Brook Illinois 60523 Recruiting
Northwestern Medicine Orland Park Orland Park Illinois 60462 Recruiting
Memorial Hospital East Shiloh Illinois 62269 Recruiting
Carle Cancer Center Urbana Illinois 61801 Recruiting
Northwestern Medicine Cancer Center Warrenville Warrenville Illinois 60555 Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny Iowa 50023 Recruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive Iowa 50325 Recruiting
Methodist Jennie Edmundson Hospital Council Bluffs Iowa 51503 Suspended
Iowa Methodist Medical Center Des Moines Iowa 50309 Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines Iowa 50309 Recruiting
Broadlawns Medical Center Des Moines Iowa 50314 Recruiting
Mercy Medical Center - Des Moines Des Moines Iowa 50314 Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines Iowa 50314 Recruiting
UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee Iowa 50263 Recruiting
University of Kansas Cancer Center Kansas City Kansas 66160 Recruiting
University of Kansas Cancer Center-Overland Park Overland Park Kansas 66210 Recruiting
University of Kansas Hospital-Westwood Cancer Center Westwood Kansas 66205 Recruiting
LSU Health Baton Rouge-North Clinic Baton Rouge Louisiana 70805 Recruiting
Our Lady of the Lake Physician Group Baton Rouge Louisiana 70808 Recruiting
Our Lady of The Lake Baton Rouge Louisiana 70808 Recruiting
Lafayette Family Cancer Center-EMMC Brewer Maine 04412 Recruiting
University of Michigan Rogel Cancer Center Ann Arbor Michigan 48109 Recruiting
University of Michigan - Brighton Center for Specialty Care Brighton Michigan 48116 Recruiting
Wayne State University/Karmanos Cancer Institute Detroit Michigan 48201 Recruiting
Henry Ford Hospital Detroit Michigan 48202 Recruiting
Weisberg Cancer Treatment Center Farmington Hills Michigan 48334 Recruiting
University of Mississippi Medical Center Jackson Mississippi 39216 Recruiting
Siteman Cancer Center at Saint Peters Hospital City of Saint Peters Missouri 63376 Recruiting
Siteman Cancer Center at West County Hospital Creve Coeur Missouri 63141 Recruiting
University of Kansas Cancer Center - Briarcliff Kansas City Missouri 64116 Recruiting
University of Kansas Cancer Center - North Kansas City Missouri 64154 Recruiting
University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri 64064 Recruiting
Washington University School of Medicine St Louis Missouri 63110 Recruiting
Siteman Cancer Center-South County St Louis Missouri 63129 Recruiting
Siteman Cancer Center at Christian Hospital St Louis Missouri 63136 Recruiting
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC Omaha Nebraska 68114 Recruiting
Nebraska Methodist Hospital Omaha Nebraska 68114 Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire 03756 Recruiting
Cooper Hospital University Medical Center Camden New Jersey 08103 Recruiting
Jersey City Medical Center Jersey City New Jersey 07302 Recruiting
Cooperman Barnabas Medical Center Livingston New Jersey 07039 Recruiting
Monmouth Medical Center Long Branch New Jersey 07740 Recruiting
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey 08903 Recruiting
Rutgers New Jersey Medical School Newark New Jersey 07101 Recruiting
Community Medical Center Toms River New Jersey 08755 Recruiting
University of Rochester Rochester New York 14642 Recruiting
Stony Brook University Medical Center Stony Brook New York 11794 Recruiting
Wilmot Cancer Institute at Webster Webster New York 14580 Recruiting
UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina 27599 Recruiting
Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina 28203 Recruiting
Atrium Health Cabarrus/LCI-Concord Concord North Carolina 28025 Recruiting
ProMedica Flower Hospital Sylvania Ohio 43560 Recruiting
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 Recruiting
Clackamas Radiation Oncology Center Clackamas Oregon 97015 Recruiting
Legacy Mount Hood Medical Center Gresham Oregon 97030 Recruiting
Providence Newberg Medical Center Newberg Oregon 97132 Recruiting
Providence Willamette Falls Medical Center Oregon City Oregon 97045 Recruiting
Legacy Good Samaritan Hospital and Medical Center Portland Oregon 97210 Recruiting
Providence Portland Medical Center Portland Oregon 97213 Recruiting
Providence Saint Vincent Medical Center Portland Oregon 97225 Recruiting
Legacy Meridian Park Hospital Tualatin Oregon 97062 Recruiting
UPMC Hillman Cancer Center Erie Erie Pennsylvania 16505 Recruiting
Saint Vincent Hospital Erie Pennsylvania 16544 Recruiting
UPMC Cancer Center at UPMC Horizon Farrell Pennsylvania 16121 Recruiting
IRMC Cancer Center Indiana Pennsylvania 15701 Recruiting
Jefferson Hospital Jefferson Hills Pennsylvania 15025 Recruiting
UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown Pennsylvania 15901 Recruiting
Forbes Hospital Monroeville Pennsylvania 15146 Recruiting
UPMC Cancer Center - Monroeville Monroeville Pennsylvania 15146 Recruiting
UPMC Hillman Cancer Center - Monroeville Monroeville Pennsylvania 15146 Recruiting
Thomas Jefferson University Hospital Philadelphia Pennsylvania 19107 Recruiting
Allegheny General Hospital Pittsburgh Pennsylvania 15212 Recruiting
UPMC-Saint Margaret Pittsburgh Pennsylvania 15215 Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania 15232 Recruiting
UPMC-Shadyside Hospital Pittsburgh Pennsylvania 15232 Recruiting
UPMC-Saint Clair Hospital Cancer Center Pittsburgh Pennsylvania 15243 Recruiting
UPMC Cancer Center at UPMC Northwest Seneca Pennsylvania 16346 Recruiting
UPMC Cancer Center-Washington Washington Pennsylvania 15301 Recruiting
UPMC Washington Hospital Radiation Oncology Washington Pennsylvania 15301 Recruiting
Wexford Health and Wellness Pavilion Wexford Pennsylvania 15090 Recruiting
Asplundh Cancer Pavilion Willow Grove Pennsylvania 19090 Recruiting
Medical University of South Carolina Charleston South Carolina 29425 Recruiting
Vanderbilt University/Ingram Cancer Center Nashville Tennessee 37232 Recruiting
Legacy Cancer Institute Medical Oncology and Day Treatment Vancouver Washington 98684 Recruiting
Legacy Salmon Creek Hospital Vancouver Washington 98686 Recruiting
University of Wisconsin Carbone Cancer Center - Johnson Creek Johnson Creek Wisconsin 53038 Recruiting
Gundersen Lutheran Medical Center La Crosse Wisconsin 54601 Recruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison Wisconsin 53718 Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin 53792 Recruiting
Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin 53051 Recruiting
Medical College of Wisconsin Milwaukee Wisconsin 53226 Recruiting
Froedtert and MCW Moorland Reserve Health Center New Berlin Wisconsin 53151 Recruiting
Drexel Town Square Health Center Oak Creek Wisconsin 53154 Recruiting
Froedtert West Bend Hospital/Kraemer Cancer Center West Bend Wisconsin 53095 Recruiting

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 NCT07195734, 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 Oct 14, 2026 · Synced Oct 16, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07195734 live on ClinicalTrials.gov.

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