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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT07195734

Registry updated: 2026-10-14
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Description

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.

Interventions

  • Biospecimen Collection (Procedure)
    Undergo blood sample collection
  • Carboplatin (Drug)
    Given IV
  • Cemiplimab (Biological)
    Given IV
  • Cisplatin (Drug)
    Given IV
  • Computed Tomography (Procedure)
    Undergo CT scan
  • Paclitaxel (Drug)
    Given IV
  • Positron Emission Tomography (Procedure)
    Undergo PET scan
  • Radiation Therapy (Radiation)
    Undergo radiation therapy
  • Salvage Surgery (Procedure)
    Undergo standard of care salvage surgery

Eligibility criteria

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)

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

Locations

  • 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
  • Stanford Cancer Institute Palo Alto — Palo Alto, 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
  • Northwestern University — Chicago, Illinois, United States
  • Rush MD Anderson Cancer Center — Chicago, Illinois, United States
  • Carle at The Riverfront — Danville, Illinois, United States
  • Northwestern Medicine Cancer Center Kishwaukee — DeKalb, Illinois, United States
  • Carle Physician Group-Effingham — Effingham, Illinois, United States
  • Northwestern Medicine Cancer Center Delnor — Geneva, Illinois, United States
  • Northwestern Medicine Glenview Outpatient Center — Glenview, Illinois, United States
  • Northwestern Medicine Grayslake Outpatient Center — Grayslake, Illinois, United States
  • Northwestern Medicine Lake Forest Hospital — Lake Forest, Illinois, United States
  • Rush MD Anderson Cancer Center at Rush Lisle — Lisle, Illinois, United States
  • Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States
  • Northwestern Medicine Oak Brook — Oak Brook, Illinois, United States
  • Northwestern Medicine Orland Park — Orland Park, Illinois, United States
  • Memorial Hospital East — Shiloh, Illinois, United States
  • Carle Cancer Center — Urbana, Illinois, United States
  • Northwestern Medicine Cancer Center Warrenville — Warrenville, 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
  • Our Lady of The Lake — 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
  • Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States
  • Henry Ford Hospital — Detroit, Michigan, United States
  • Weisberg Cancer Treatment Center — Farmington Hills, Michigan, United States
  • University of Mississippi Medical Center — Jackson, Mississippi, 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
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center — Lebanon, New Hampshire, United States
  • Cooper Hospital University Medical Center — Camden, New Jersey, United States
  • Jersey City Medical Center — Jersey City, New Jersey, United States
  • Cooperman 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
  • University of Rochester — Rochester, New York, United States
  • Stony Brook University Medical Center — Stony Brook, New York, United States
  • Wilmot Cancer Institute at Webster — Webster, 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 — Pittsburgh, Pennsylvania, United States
  • UPMC-Saint Margaret — Pittsburgh, Pennsylvania, United States
  • UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • UPMC-Shadyside Hospital — Pittsburgh, Pennsylvania, United States
  • UPMC-Saint Clair Hospital Cancer Center — Pittsburgh, Pennsylvania, United States
  • UPMC Cancer Center at UPMC Northwest — Seneca, Pennsylvania, United States
  • UPMC Cancer Center-Washington — Washington, Pennsylvania, United States
  • UPMC Washington Hospital Radiation Oncology — Washington, Pennsylvania, United States
  • Wexford Health and Wellness Pavilion — Wexford, Pennsylvania, United States
  • Asplundh Cancer Pavilion — Willow Grove, Pennsylvania, United States
  • Medical University of South Carolina — Charleston, South Carolina, United States
  • Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
  • Legacy Cancer Institute Medical Oncology and Day Treatment — Vancouver, Washington, United States
  • Legacy Salmon Creek Hospital — Vancouver, Washington, United States
  • University of Wisconsin Carbone Cancer Center - Johnson Creek — Johnson Creek, Wisconsin, United States
  • Gundersen Lutheran Medical Center — La Crosse, Wisconsin, United States
  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center — Madison, Wisconsin, United States
  • University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin, 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record