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RECRUITING
NCT07195734
PHASE2

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

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Carboplatin

Given IV

BIOLOGICAL

Cemiplimab

Given IV

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Paclitaxel

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET scan

RADIATION

Radiation Therapy

Undergo radiation therapy

PROCEDURE

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