AzTrials
AzTrials

Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Phase 2NCT07195734

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

A Phase 2 study testing Biospecimen Collection, Carboplatin and Cemiplimab in people with Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, run by National Cancer Institute (NCI) at 115 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Carboplatin and Cemiplimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
115 sitesUnited States
Study dates
24 Apr 2026to 1 Feb 2033
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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)

Who cannot join

None listed.

Trial locations and contacts

115 sites in 1 country. Contact the study team or a site near you to ask about taking part.

115 sites in 1 country

United States115 sites, 114 recruiting

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu

    Paul L. Swiecicki

    Recruiting

  • Emory Proton Therapy Center

    Atlanta, Georgia, 30308

    Site Public Contact, 404-251-2854, allyson.anderson@emory.edu

    Jennifer Gross

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Jennifer Gross

    Recruiting

  • LSU Health Baton Rouge-North Clinic

    Baton Rouge, Louisiana, 70805

    Site Public Contact, 225-765-7659, research@ololrmc.com

    Sagar G. Kansara

    Recruiting

  • Our Lady of the Lake Physician Group

    Baton Rouge, Louisiana, 70808

    Site Public Contact, 225-765-7659, research@ololrmc.com

    Sagar G. Kansara

    Recruiting

  • Our Lady of The Lake

    Baton Rouge, Louisiana, 70808

    Site Public Contact, 225-765-7659

    Sagar G. Kansara

    Recruiting

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

    Site Public Contact, 800-987-3005

    Sarah J. Sinclair

    Recruiting

  • University of Michigan - Brighton Center for Specialty Care

    Brighton, Michigan, 48116

    Site Public Contact, 800-865-1125

    Paul L. Swiecicki

    Recruiting

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

    Site Public Contact, 856-325-6757

    Brian Swendseid

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu

    Mihir R. Patel

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu

    Alexandra E. Kejner

    Recruiting

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

    Site Public Contact, 800-804-9376

    Matthew C. Ward

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Jochen H. Lorch

    Recruiting

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

    Site Public Contact, 312-226-2371, Cancer_Studies@rush.edu

    Michael J. Jelinek

    Recruiting

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Brendan J. Knapp

    Recruiting

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Dan S. Zuckerman

    Recruiting

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

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025

    Site Public Contact, 800-804-9376

    Matthew C. Ward

    Recruiting

  • Methodist Jennie Edmundson Hospital

    Council Bluffs, Iowa, 51503

    Suspended

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Brendan J. Knapp

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Suparna Mantha

    Recruiting

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Jochen H. Lorch

    Recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting

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

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

    Site Public Contact, 515-282-2200

    Seema Harichand-Herdt

    Recruiting

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Site Public Contact, 800-527-6266, ctoadmin@karmanos.org

    Ammar Sukari

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Samantha H. Tam

    Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Suparna Mantha

    Recruiting

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Steven B. Chinn

    Recruiting

  • Saint Vincent Hospital

    Erie, Pennsylvania, 16544

    Site Public Contact, 814-452-5000

    Larisa Greenberg

    Recruiting

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    Ammar Sukari

    Recruiting

  • UPMC Cancer Center at UPMC Horizon

    Farrell, Pennsylvania, 16121

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Steven B. Chinn

    Recruiting

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Jochen H. Lorch

    Recruiting

  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois, 60026

    Site Public Contact, 312-695-1102

    Jochen H. Lorch

    Recruiting

  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030

    Site Public Contact, 312-695-1102

    Jochen H. Lorch

    Recruiting

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

    Site Public Contact, 503-413-2150

    Andrew Y. Kee

    Recruiting

  • IRMC Cancer Center

    Indiana, Pennsylvania, 15701

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Steven B. Chinn

    Recruiting

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Victoria M. Villaflor

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Site Public Contact, 601-815-6700

    Gina Jefferson

    Recruiting

  • Jefferson Hospital

    Jefferson Hills, Pennsylvania, 15025

    Site Public Contact, 412-359-3043, ddefazio@wpahs.org

    Larisa Greenberg

    Recruiting

  • Jersey City Medical Center

    Jersey City, New Jersey, 07302

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Dylan F. Roden

    Recruiting

  • University of Wisconsin Carbone Cancer Center - Johnson Creek

    Johnson Creek, Wisconsin, 53038

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Justine Yang-Bruce

    Recruiting

  • UPMC-Johnstown/John P. Murtha Regional Cancer Center

    Johnstown, Pennsylvania, 15901

    Site Public Contact, 814-534-4724

    Steven B. Chinn

    Recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Omar A. Karadaghy

    Recruiting

  • University of Kansas Cancer Center - Briarcliff

    Kansas City, Missouri, 64116

    Site Public Contact, 913-588-3671

    Omar A. Karadaghy

    Recruiting

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Omar A. Karadaghy

    Recruiting

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

    Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org

    Collin D. Driscoll

    Recruiting

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

    Site Public Contact, cancertrials@northwestern.edu

    Jochen H. Lorch

    Recruiting

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

    Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu

    Joseph A. Paydarfar

    Recruiting

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Omar A. Karadaghy

    Recruiting

  • Rush MD Anderson Cancer Center at Rush Lisle

    Lisle, Illinois, 60532

    Site Public Contact, 312-226-2371, Cancer_Studies@rush.edu

    Michael J. Jelinek

    Recruiting

  • Cooperman Barnabas Medical Center

    Livingston, New Jersey, 07039

    Site Public Contact, 973-322-5200

    Dylan F. Roden

    Recruiting

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

    Site Public Contact, 732-923-6564, mary.danish@rwjbh.org

    Dylan F. Roden

    Recruiting

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Site Public Contact, 323-865-0451

    Jacob S. Thomas

    Recruiting

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Justine Yang-Bruce

    Recruiting

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Justine Yang-Bruce

    Recruiting

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

    Site Public Contact, 800-446-5532, Research@carle.com

    Suparna Mantha

    Recruiting

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

    Site Public Contact, 262-257-5100

    Jennifer D. Bruening

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Site Public Contact, 414-805-3666

    Jennifer D. Bruening

    Recruiting

  • Forbes Hospital

    Monroeville, Pennsylvania, 15146

    Site Public Contact, 412-858-7746

    Larisa Greenberg

    Recruiting

  • UPMC Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Steven B. Chinn

    Recruiting

  • UPMC Hillman Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Steven B. Chinn

    Recruiting

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

    Site Public Contact, 800-811-8480

    Jennifer H. Choe

    Recruiting

  • Froedtert and MCW Moorland Reserve Health Center

    New Berlin, Wisconsin, 53151

    Site Public Contact, 414-805-0505

    Jennifer D. Bruening

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

    Site Public Contact, 732-235-7356

    Dylan F. Roden

    Recruiting

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07101

    Site Public Contact, 732-235-7356

    Dylan F. Roden

    Recruiting

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Dan S. Zuckerman

    Recruiting

  • Northwestern Medicine Oak Brook

    Oak Brook, Illinois, 60523

    Site Public Contact, nctnprogram_rhlccc@northwestern.edu

    Jochen H. Lorch

    Recruiting

  • Drexel Town Square Health Center

    Oak Creek, Wisconsin, 53154

    Site Public Contact, 414-805-0505

    Jennifer D. Bruening

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Christina Henson

    Recruiting

  • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

    Omaha, Nebraska, 68114

    Site Public Contact, 402-334-4773

    Yungpo B. Su

    Recruiting

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

    Site Public Contact, 402-354-5144

    Yungpo B. Su

    Recruiting

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Victoria M. Villaflor

    Recruiting

  • Providence Willamette Falls Medical Center

    Oregon City, Oregon, 97045

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Dan S. Zuckerman

    Recruiting

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462

    Site Public Contact, nctnprogram_rhlccc@northwestern.edu

    Jochen H. Lorch

    Recruiting

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Omar A. Karadaghy

    Recruiting

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

    Site Public Contact, 650-498-7061, cancertrialsinfo@stanford.edu

    Michelle Chen

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Jennifer M. Johnson

    Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Site Public Contact, 877-284-2000

    Larisa Greenberg

    Recruiting

  • UPMC-Saint Margaret

    Pittsburgh, Pennsylvania, 15215

    Site Public Contact, 412-784-4900

    Steven B. Chinn

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Site Public Contact, 412-647-8073

    Steven B. Chinn

    Recruiting

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

    Site Public Contact, 412-621-2334

    Steven B. Chinn

    Recruiting

  • UPMC-Saint Clair Hospital Cancer Center

    Pittsburgh, Pennsylvania, 15243

    Site Public Contact, 412-502-3920

    Steven B. Chinn

    Recruiting

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

    Site Public Contact, 800-220-4937, cancer@lhs.org

    Andrew Y. Kee

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Dan S. Zuckerman

    Recruiting

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Dan S. Zuckerman

    Recruiting

  • University of Rochester

    Rochester, New York, 14642

    Site Public Contact, 585-275-5830

    Monaliben Patel

    Recruiting

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

    Site Public Contact, 916-734-3089

    Andrew C. Birkeland

    Recruiting

  • UPMC Cancer Center at UPMC Northwest

    Seneca, Pennsylvania, 16346

    Site Public Contact, 814-676-7900

    Steven B. Chinn

    Recruiting

  • Memorial Hospital East

    Shiloh, Illinois, 62269

    Site Public Contact, 314-747-9912, dschwab@wustl.edu

    Brendan J. Knapp

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Brendan J. Knapp

    Recruiting

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Brendan J. Knapp

    Recruiting

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Brendan J. Knapp

    Recruiting

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

    Site Public Contact, 800-862-2215

    Achuta K. Guddati

    Recruiting

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

    Site Public Contact, 419-824-1842, PCIOncResearch@promedica.org

    Chang Xia

    Recruiting

  • Community Medical Center

    Toms River, New Jersey, 08755

    Site Public Contact, 732-557-8294, Lennette.Gonzales@rwjbh.org

    Dylan F. Roden

    Recruiting

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

    Site Public Contact, 503-413-1742

    Andrew Y. Kee

    Recruiting

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

    Site Public Contact, UACC-IIT@uacc.arizona.edu

    Ricklie A. Julian

    Recruiting

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

    Site Public Contact, UACC-IIT@uacc.arizona.edu

    Ricklie A. Julian

    Recruiting

  • Carle Cancer Center

    Urbana, Illinois, 61801

    Site Public Contact, 800-446-5532, Research@carle.com

    Suparna Mantha

    Recruiting

  • Legacy Cancer Institute Medical Oncology and Day Treatment

    Vancouver, Washington, 98684

    Site Public Contact, oncologyresearch@lhs.org

    Andrew Y. Kee

    Recruiting

  • Legacy Salmon Creek Hospital

    Vancouver, Washington, 98686

    Site Public Contact, 503-413-2150

    Andrew Y. Kee

    Recruiting

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Jochen H. Lorch

    Recruiting

  • UPMC Cancer Center-Washington

    Washington, Pennsylvania, 15301

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Steven B. Chinn

    Recruiting

  • UPMC Washington Hospital Radiation Oncology

    Washington, Pennsylvania, 15301

    Site Public Contact, 724-223-3788, cancer@washingtonhospital.org

    Steven B. Chinn

    Recruiting

  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    Waukee, Iowa, 50263

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Wilmot Cancer Institute at Webster

    Webster, New York, 14580

    Site Public Contact, WCICTOresearch@urmc.rochester.edu

    Monaliben Patel

    Recruiting

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    West Bend, Wisconsin, 53095

    Site Public Contact, 414-805-0505

    Jennifer D. Bruening

    Recruiting

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Omar A. Karadaghy

    Recruiting

  • Wexford Health and Wellness Pavilion

    Wexford, Pennsylvania, 15090

    Site Public Contact, Dawnmarie.DeFazio@ahn.org

    Larisa Greenberg

    Recruiting

  • Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania, 19090

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Jennifer M. Johnson

    Recruiting

Other trials in United States

About this study

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)

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess and compare investigator-assessed event-free survival (EFS) of patients treated with chemotherapy (carboplatin + paclitaxel) or chemo-immunotherapy (carboplatin + paclitaxel + cemiplimab [REGN2810]) prior to salvage surgery (SS) versus patients undergoing standard of care SS.

SECONDARY OBJECTIVES:

  1. To assess and compare disease-free survival (DFS). II. To assess and compare overall survival (OS). III. To assess and compare distant metastasis (DM). IV. To assess and compare acute and late toxicity (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0), and surgical complications.
  2. To assess radiographic response (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) to neoadjuvant therapy in the experimental arms.

VI. To assess pathologic response in the experimental arms.

EXPLORATORY OBJECTIVES:

  1. To assess and compare clinical outcomes (EFS, DFS, OS, DM, and response) within the PD-L1 subgroups (combined positive score < 20 versus ≥ 20).

II. To determine the impact of surgical quality benchmarks (margin assessment, cervical lymph node harvest collected per central surgery review) and oncologic outcomes.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM 1: Patients undergo standard of care salvage surgery. Starting within 8 weeks of surgery, patients with high risk features also undergo radiation therapy daily for 5 treatments per week for 6 weeks and receive cisplatin intravenously (IV) once per week for 6 weeks during radiation treatment, in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan, positron emission tomography (PET) scan and optionally undergo blood sample collection throughout the study.

ARM 2: Patients receive paclitaxel IV and carboplatin IV on day 1 of each cycle. Cycles repeat every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. 6-10 weeks after cycle 1 day 1 patients undergo standard of care salvage surgery. Starting within 8 weeks of surgery, patients with high risk features also undergo radiation therapy daily for 5 treatments per week for 6 weeks and receive cisplatin IV once per week for 6 weeks during radiation treatment, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan and optionally undergo blood sample collection throughout the study.

ARM 3: Patients receive paclitaxel IV, carboplatin IV and cemiplimab IV, over 30 minutes, on day 1 of each cycle. Cycles repeat every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. 6-10 weeks after cycle 1 day 1 patients undergo standard of care salvage surgery. Starting within 8 weeks of surgery, patients with high risk features also undergo radiation therapy daily for 5 treatments per week for 6 weeks and receive cisplatin IV once per week for 6 weeks during radiation treatment, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan and optionally undergo blood sample collection throughout the study.

After completion of study treatment, patients are followed up at 12 weeks or at the end of post operative radiation, then every 3 months for 2 years, every 6 months for years 3 and 4 and annually thereafter.

Being tested
Biospecimen Collection, Carboplatin, Cemiplimab, Cisplatin, Computed Tomography
Medical subject headings
Oropharyngeal Neoplasms, Laryngeal Neoplasms, Mouth Neoplasms, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • CemiplimabBiological

    Also called Cemiplimab RWLC, Cemiplimab-rwlc, Libtayo, REGN 2810

    Given IV

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET scan

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate

    Undergo radiation therapy

  • Salvage SurgeryProcedure or surgery

    Also called Rescue Surgery, Salvage Resection, Salvage Surgical Resection, Surgical Salvage

    Undergo standard of care salvage surgery

Study groups in NCT07195734
Study groupRoleWhat they receive
Arm 1 (Salvage surgery)Active comparatorPatients undergo standard of care salvage surgery. Starting within 8 weeks of surgery, patients with high risk features also undergo radiation therapy daily for 5 treatments per week for 6 weeks and receive cisplatin IV once per week for 6 weeks during radiation treatment, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan and optionally undergo blood sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Drug: Cisplatin; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Radiation: Radiation Therapy; Procedure: Salvage Surgery
Arm 2 (Chemotherapy, salvage surgery)ExperimentalPatients receive paclitaxel IV and carboplatin IV on day 1 of each cycle. Cycles repeat every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. 6-10 weeks after cycle 1 day 1 patients undergo standard of care salvage surgery. Starting within 8 weeks of surgery, patients with high risk features also undergo radiation therapy daily for 5 treatments per week for 6 weeks and receive cisplatin IV once per week for 6 weeks during radiation treatment, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan and optionally undergo blood sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Paclitaxel; Procedure: Positron Emission Tomography; Radiation: Radiation Therapy; Procedure: Salvage Surgery
Arm 3 (Chemo-immunotherapy, salvage surgery)ExperimentalPatients receive paclitaxel IV, carboplatin IV and cemiplimab IV, over 30 minutes, on day 1 of each cycle. Cycles repeat every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. 6-10 weeks after cycle 1 day 1 patients undergo standard of care salvage surgery. Starting within 8 weeks of surgery, patients with high risk features also undergo radiation therapy daily for 5 treatments per week for 6 weeks and receive cisplatin IV once per week for 6 weeks during radiation treatment, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan and optionally undergo blood sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Drug: Carboplatin; Biological: Cemiplimab; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Paclitaxel; Procedure: Positron Emission Tomography; Radiation: Radiation Therapy; Procedure: Salvage Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event free survival (EFS)

    Will be summarized by treatment arm using standard Kaplan-Meier methods, reporting the estimated 2-year EFS rate with corresponding 95% confidence intervals.

    Measured: From randomization to disease progression or treatment-related toxicities that precludes surgery, disease progression in the absence of surgery, disease recurrence after surgery, or death due to any cause, up to 7 years

Secondary outcomes (8)

  1. Disease free survival (DFS)

    Will be summarized by treatment arm using standard Kaplan-Meier methods, where estimates of the 2-year DFS will be obtained with 95% confidence intervals. Comparisons between the experimental arms and the control arm will be made using the stratified log-rank test.

    Measured: From randomization until disease recurrence, death due to any cause, up to 7 years

  2. Overall survival (OS)

    Will be summarized by treatment arm using standard Kaplan-Meier methods, where estimates of the 2-year OS will be obtained with 95% confidence intervals. Comparisons between the experimental arms and the control arm will be made using the stratified log-rank test.

    Measured: From randomization until death due to any cause, up to 7 years

  3. Time to distant metastasis

    The cumulative incidence method will be used to estimate the incidence of distant metastases; where estimates of the 2-year distant metastasis rates will be obtained with 95% confidence intervals. Comparisons between the experimental arms and the control arm will be made using the stratified Gray's test.

    Measured: From randomization until detection of distant metastases or death, up to 7 years

  4. Surgical complications

    Will be assessed using the Comprehensive Complication Index. Surgical complications will be summarized by treatment arm using frequencies and relative frequencies; where the overall complication rate will be estimated by treatment arm using 95% confidence intervals obtained by the Clopper-Pearson method. Comparisons between the experimental arms and the control arm will be made using the Cochran-Mantel-Haenszel test.

    Measured: Up to 7 years

  5. Incidence of acute adverse events

    Assessed by Common Terminology Critiera for Adverse Events (CTCAE) version (v) 5.0. The overall (highest grade) acute toxicities will be summarized by treatment arm using frequencies and relative frequencies.

    Measured: Up to 30 days from the last treatment

  6. Incidence of late adverse events

    Assessed by CTCAE v 5.0. The overall (highest grade) late toxicities will be summarized by treatment arm using frequencies and relative frequencies.

    Measured: From day 31 to 180 days from the last treatment

  7. Radiographic response (Arm 2 and 3)

    Response will be assessed using Response Evaluation Criteria in Solid Tumors 1.1. Best response will be summarized by treatment arm using frequencies and relative frequencies; where the complete (CR) and objective response rates (CR + partial response) will be estimated using 95% confidence intervals obtained by the Clopper-Pearson method.

    Measured: Up to 7 years

  8. Major pathological response (mPR) (Arm 2 and 3)

    mPR will be summarized by treatment arm using frequencies and relative frequencies; where the mPR rates will be estimated using 95% confidence intervals obtained by the Clopper-Pearson method.

    Measured: Up to 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2025
  2. Study start24 Apr 2026
  3. Primary completion1 Feb 2033 (estimated)
  4. Study completion1 Feb 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07195734
Sponsor's protocol ID
NCI-2025-06920
Other IDs
NCI-2025-06920, NRG-HN015, NRG-HN015, U10CA180868
Status last verified
Oct 2026
First submitted
26 Sep 2025
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Carboplatin and Cemiplimab in people with Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, run by National Cancer Institute (NCI) at 115 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 41 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event free survival (EFS) (time frame: From randomization to disease progression or treatment-related toxicities that precludes surgery, disease progression in the absence of surgery, disease recurrence after surgery, or death due to any cause, up to 7 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07195734.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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