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Clinical trialNCT07195734RecruitingPhase 2Interventional

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

SponsorNational Cancer Institute (NCI)Enrollment180Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Locally Recurrent Head and Neck Squamous Cell CarcinomaLocally Recurrent Hypopharyngeal Squamous Cell CarcinomaLocally Recurrent Laryngeal Squamous Cell CarcinomaLocally Recurrent Oral Cavity Squamous Cell Carcinoma+12 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

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

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

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

United States
  • Banner University Medical Center - Tucson

    Tucson, Arizona, United States

    Ricklie A. Julian
    Recruiting
  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, United States

    Ricklie A. Julian
    Recruiting
  • Usc / Norris Comprehensive Cancer Center

    Los Angeles, California, United States

    Jacob S. Thomas
    Recruiting
  • Sutter Medical Center Sacramento

    Sacramento, California, United States

    Christopher U. Jones
    Recruiting
  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, United States

    Andrew C. Birkeland
    Recruiting
  • Emory Proton Therapy Center

    Atlanta, Georgia, United States

    Jennifer Gross
    Recruiting
  • Emory University Hospital Midtown

    Atlanta, Georgia, United States

    Jennifer Gross
    Recruiting
  • Northwestern University

    Chicago, Illinois, United States

    Jochen H. Lorch
    Recruiting
  • Rush Md Anderson Cancer Center

    Chicago, Illinois, United States

    Michael J. Jelinek
    Recruiting
  • Carle at the Riverfront

    Danville, Illinois, United States

    Suparna Mantha
    Recruiting
  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, United States

    Jochen H. Lorch
    Recruiting
  • Carle Physician Group-Effingham

    Effingham, Illinois, United States

    Suparna Mantha
    Recruiting
  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, United States

    Jochen H. Lorch
    Recruiting
  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois, United States

    Jochen H. Lorch
    Recruiting
  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, United States

    Jochen H. Lorch
    Recruiting
  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, United States

    Jochen H. Lorch
    Recruiting
  • Rush Md Anderson Cancer Center at Rush Lisle

    Lisle, Illinois, United States

    Michael J. Jelinek
    Recruiting
  • Carle Physician Group-Mattoon/charleston

    Mattoon, Illinois, United States

    Suparna Mantha
    Recruiting
  • Northwestern Medicine Oak Brook

    Oak Brook, Illinois, United States

    Jochen H. Lorch
    Recruiting
  • Northwestern Medicine Orland Park

    Orland Park, Illinois, United States

    Jochen H. Lorch
    Recruiting
  • Memorial Hospital East

    Shiloh, Illinois, United States

    Brendan J. Knapp
    Recruiting
  • Carle Cancer Center

    Urbana, Illinois, United States

    Suparna Mantha
    Recruiting
  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, United States

    Jochen H. Lorch
    Recruiting
  • Ui Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, United States

    Seema Harichand-Herdt
    Recruiting
  • Ui Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, United States

    Seema Harichand-Herdt
    Recruiting
  • Methodist Jennie Edmundson Hospital

    Council Bluffs, Iowa, United States

    Suspended
  • Broadlawns Medical Center

    Des Moines, Iowa, United States

    Seema Harichand-Herdt
    Recruiting
  • Iowa Methodist Medical Center

    Des Moines, Iowa, United States

    Seema Harichand-Herdt
    Recruiting
  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, United States

    Richard L. Deming
    Recruiting
  • Ui Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, United States

    Seema Harichand-Herdt
    Recruiting
  • Ui Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, United States

    Seema Harichand-Herdt
    Recruiting
  • Ui Health Care Mission Cancer and Blood - Waukee Clinic

    Waukee, Iowa, United States

    Seema Harichand-Herdt
    Recruiting
  • University of Kansas Cancer Center

    Kansas City, Kansas, United States

    Omar A. Karadaghy
    Recruiting
  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, United States

    Omar A. Karadaghy
    Recruiting
  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, United States

    Omar A. Karadaghy
    Recruiting
  • Lsu Health Baton Rouge-North Clinic

    Baton Rouge, Louisiana, United States

    Sagar G. Kansara
    Recruiting
  • Our Lady of the Lake Physician Group

    Baton Rouge, Louisiana, United States

    Sagar G. Kansara
    Recruiting
  • Lafayette Family Cancer Center-Emmc

    Brewer, Maine, United States

    Sarah J. Sinclair
    Recruiting
  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, United States

    Paul L. Swiecicki
    Recruiting
  • University of Michigan - Brighton Center for Specialty Care

    Brighton, Michigan, United States

    Paul L. Swiecicki
    Recruiting
66 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.

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
24 Apr 2026
Primary completion
1 Feb 2033
Completion
1 Feb 2033
Last update posted
18 Aug 2026
Registered enrollment
180
Registry id
NCT07195734

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.