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Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
Sponsor: National Cancer Institute (NCI)
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. 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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-10-09
Completion Date
2033-02-01
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Biospecimen Collection
Undergo blood sample collection
Carboplatin
Given IV
Cemiplimab
Given IV
Cisplatin
Given IV
Computed Tomography
Undergo CT scan
Paclitaxel
Given IV
Positron Emission Tomography
Undergo PET scan
Radiation Therapy
Undergo radiation therapy
Salvage Surgery
Undergo standard of care salvage surgery
Locations (28)
Sutter Medical Center Sacramento
Sacramento, California, United States
Emory Proton Therapy Center
Atlanta, Georgia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, United States
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan, United States
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha, Nebraska, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, United States
Drexel Town Square Health Center
Oak Creek, Wisconsin, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, United States