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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

2026-04-24

Completion Date

2033-02-01

Last Updated

2026-07-13

Healthy Volunteers

Conditions

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

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

Inclusion Criteria: * Pathologically (histologically or cytologically) proven diagnosis of locally recurrent or persistent squamous cell carcinoma of head and neck (SCCHN) arising within the oral cavity, oropharynx, larynx, or hypopharynx * PD-L1 combined positive score (CPS) ≥ 1 using a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory * Verify insurance (or other payment) coverage for neoadjuvant chemotherapy * Measurable disease as defined by RECIST 1.1 * Patients must have locally recurrent or persistent SCCHN arising within the oral cavity, oropharynx, larynx, or hypopharynx (American Joint Committee on Cancer \[AJCC\] Cancer Staging Manual, 8th Edition) AND are deemed candidates for salvage surgery: * P16 positive oropharynx patients with T2, T3, T4, N0, N1, N2 and all other patients with T2, T3, T4a, N0, N1, N2a, N2b, N2c, N3a are eligible. * Patients must be deemed surgically resectable without gross residual disease. * For patients with oral cavity SCCHN, only those with recurrent or persistent disease after prior surgery are eligible. * Patients who are candidates for salvage laryngectomy to treat recurrent laryngeal cancer and who are having salvage surgery for curative intent are eligible. * Patients with resectable lymph node-only recurrence are eligible. * No major vascular involvement (\> 180° involvement of the common carotid or internal carotid artery), jugular foramen involvement, or prevertebral, paraspinous muscle involvement precluding a curative resection * No evidence of distant metastatic disease * The following minimum diagnostic workup is required: * General history and physical examination. * Diagnostic-quality neck CT and PET/CT of neck (PET with attenuation-correction CT of neck, chest, and abdomen) * Age ≥ 18 * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Negative urine or serum pregnancy test (in persons of childbearing potential) within 30 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3 * Platelets ≥ 100,000 cells/mm\^3 * Hemoglobin ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] ≥ 8.0 g/dL is acceptable) * Adequate renal function defined as creatinine clearance (CrCL) \> 50 mL/min by the Cockcroft-Gault formula * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN * Only patients who received prior radiation therapy in the definitive or post-operative setting (limited to one course) are eligible. * Prior radiation therapy must have been completed at least 6 months prior to registration with the majority of the index persistent/recurrent cancer volume (\> 50%) irradiated to ≥ 40 Gy at the time * Prior systemic therapy including immunotherapy with anti-PD1 or anti-PDL1 within the definitive setting (neo-adjuvant, or adjuvant) is permitted and must have been completed at least 4 months prior to registration * Prior systemic therapy including immunotherapy for treatment of recurrent or metastatic SCCHN is not permitted * No investigational anti-cancer agents received within 4 weeks prior to registration * No New York Heart Association Functional Classification III or IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification) * No active infection requiring IV antibiotics, IV antiviral, or IV antifungal treatments * No peripheral neuropathy grade 3 or 4 * No history of interstitial lung disease * No active, noninfectious pneumonitis requiring immunosuppressive therapy * No history of a solid organ transplant (other than corneal transplant) * No active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease-modifying agents, corticosteroids \[\> 10 mg prednisone/day or equivalent\] or immunosuppressive drugs) * NOTE: Patients meeting the following criteria are not considered immunosuppressed and are eligible to enroll: * Patients who require a brief course of steroids (e.g., prophylaxis for imaging assessments due to hypersensitivity to contrast agents) are not excluded * Patients with type I diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll * Physiologic replacement doses ≤ 10 mg prednisone/day or equivalent are allowed. Inhaled or topical steroids are permitted * No history of allergic reaction to the study agent, compounds of similar chemical or biologic composition to the study agent, and immune checkpoint inhibitors (or any of its excipients)

Locations (92)

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Emory Proton Therapy Center

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Rush MD Anderson Cancer Center

Chicago, Illinois, United States

Rush MD Anderson Cancer Center at Rush Lisle

Lisle, Illinois, United States

Northwestern Medicine Orland Park

Orland Park, Illinois, United States

Memorial Hospital East

Shiloh, Illinois, United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Methodist Jennie Edmundson Hospital

Council Bluffs, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Broadlawns Medical Center

Des Moines, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, 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

Lafayette Family Cancer Center-EMMC

Brewer, Maine, 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

Henry Ford Hospital

Detroit, Michigan, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 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

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

Omaha, Nebraska, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Cooper Hospital University Medical Center

Camden, New Jersey, United States

Jersey City Medical Center

Jersey City, New Jersey, United States

Saint Barnabas Medical Center

Livingston, New Jersey, United States

Monmouth Medical Center

Long Branch, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Rutgers New Jersey Medical School

Newark, New Jersey, United States

Community Medical Center

Toms River, New Jersey, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, United States

ProMedica Flower Hospital

Sylvania, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Legacy Mount Hood Medical Center

Gresham, Oregon, United States

Providence Newberg Medical Center

Newberg, Oregon, United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, United States

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Legacy Meridian Park Hospital

Tualatin, Oregon, United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, United States

Saint Vincent Hospital

Erie, Pennsylvania, United States

UPMC Cancer Center at UPMC Horizon

Farrell, Pennsylvania, United States

IRMC Cancer Center

Indiana, Pennsylvania, United States

Jefferson Hospital

Jefferson Hills, Pennsylvania, United States

UPMC-Johnstown/John P. Murtha Regional Cancer Center

Johnstown, Pennsylvania, United States

Forbes Hospital

Monroeville, Pennsylvania, United States

UPMC Cancer Center - Monroeville

Monroeville, Pennsylvania, United States

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Allegheny General Hospital