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New combo therapy aims to stop head and neck cancer from returning

NCT ID NCT07195734

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 30 times

Summary

This phase II trial is testing whether adding chemotherapy or chemo-immunotherapy before standard salvage surgery can improve outcomes for patients with PD-L1 positive head and neck cancer that has come back. About 180 participants will receive either carboplatin and paclitaxel, or those drugs plus the immunotherapy cemiplimab, before surgery. The goal is to see if these combinations help keep the cancer from returning longer than surgery alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Carboplatin, paclitaxel, and cemiplimab (a monoclonal antibody)
What this could lead to
If successful, this approach could help control recurrent head and neck cancer better than surgery alone, potentially delaying or preventing the cancer from coming back.
What could go wrong
This is an early phase II trial with only 180 participants, so results may not apply to everyone. Adding chemotherapy and immunotherapy before surgery also increases the risk of side effects like fatigue, nausea, and immune-related reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Feb 2033

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

carcinoma head and neck squamous cell carcinoma hypopharynx squamous cell carcinoma laryngeal carcinoma laryngeal neoplasm laryngeal squamous cell carcinoma larynx cancer lip and oral cavity carcinoma lip and oral cavity squamous cell carcinoma Mouth Neoplasms oral cavity squamous cell carcinoma oropharyngeal carcinoma oropharynx cancer oropharynx squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    110 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allegheny General Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Asplundh Cancer Pavilion

    RECRUITING

    Willow Grove, Pennsylvania, 19090, United States

    Contact Email: •••••@•••••

  • Atrium Health Cabarrus/LCI-Concord

    RECRUITING

    Concord, North Carolina, 28025, United States

  • Banner University Medical Center - Tucson

    RECRUITING

    Tucson, Arizona, 85719, United States

  • Broadlawns Medical Center

    RECRUITING

    Des Moines, Iowa, 50314, United States

  • Carle Cancer Center

    RECRUITING

    Urbana, Illinois, 61801, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Effingham

    RECRUITING

    Effingham, Illinois, 62401, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Mattoon/Charleston

    RECRUITING

    Mattoon, Illinois, 61938, United States

    Contact Email: •••••@•••••

  • Carle at The Riverfront

    RECRUITING

    Danville, Illinois, 61832, United States

    Contact Email: •••••@•••••

  • Carolinas Medical Center/Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Clackamas Radiation Oncology Center

    SUSPENDED

    Clackamas, Oregon, 97015, United States

  • Community Medical Center

    RECRUITING

    Toms River, New Jersey, 08755, United States

  • Cooper Hospital University Medical Center

    RECRUITING

    Camden, New Jersey, 08103, United States

  • Cooperman Barnabas Medical Center

    RECRUITING

    Livingston, New Jersey, 07039, United States

  • Drexel Town Square Health Center

    RECRUITING

    Oak Creek, Wisconsin, 53154, United States

  • Emory Proton Therapy Center

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Emory University Hospital Midtown

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Forbes Hospital

    RECRUITING

    Monroeville, Pennsylvania, 15146, United States

  • Froedtert Menomonee Falls Hospital

    RECRUITING

    Menomonee Falls, Wisconsin, 53051, United States

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    RECRUITING

    West Bend, Wisconsin, 53095, United States

  • Froedtert and MCW Moorland Reserve Health Center

    RECRUITING

    New Berlin, Wisconsin, 53151, United States

  • Gundersen Lutheran Medical Center

    RECRUITING

    La Crosse, Wisconsin, 54601, United States

    Contact Email: •••••@•••••

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

    Contact Email: •••••@•••••

  • IRMC Cancer Center

    RECRUITING

    Indiana, Pennsylvania, 15701, United States

  • Iowa Methodist Medical Center

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • Jefferson Hospital

    RECRUITING

    Jefferson Hills, Pennsylvania, 15025, United States

  • Jersey City Medical Center

    RECRUITING

    Jersey City, New Jersey, 07302, United States

  • LSU Health Baton Rouge-North Clinic

    RECRUITING

    Baton Rouge, Louisiana, 70805, United States

    Contact Email: •••••@•••••

  • Lafayette Family Cancer Center-EMMC

    RECRUITING

    Brewer, Maine, 04412, United States

  • Legacy Cancer Institute Medical Oncology and Day Treatment

    RECRUITING

    Vancouver, Washington, 98684, United States

    Contact Email: •••••@•••••

  • Legacy Good Samaritan Hospital and Medical Center

    RECRUITING

    Portland, Oregon, 97210, United States

    Contact Email: •••••@•••••

  • Legacy Meridian Park Hospital

    RECRUITING

    Tualatin, Oregon, 97062, United States

  • Legacy Mount Hood Medical Center

    RECRUITING

    Gresham, Oregon, 97030, United States

  • Legacy Salmon Creek Hospital

    RECRUITING

    Vancouver, Washington, 98686, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Memorial Hospital East

    RECRUITING

    Shiloh, Illinois, 62269, United States

  • Mercy Medical Center - Des Moines

    RECRUITING

    Des Moines, Iowa, 50314, United States

  • Methodist Jennie Edmundson Hospital

    SUSPENDED

    Council Bluffs, Iowa, 51503, United States

  • Monmouth Medical Center

    RECRUITING

    Long Branch, New Jersey, 07740, United States

  • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

    RECRUITING

    Omaha, Nebraska, 68114, United States

  • Nebraska Methodist Hospital

    RECRUITING

    Omaha, Nebraska, 68114, United States

  • Northwestern Medicine Cancer Center Delnor

    RECRUITING

    Geneva, Illinois, 60134, United States

  • Northwestern Medicine Cancer Center Kishwaukee

    RECRUITING

    DeKalb, Illinois, 60115, United States

  • Northwestern Medicine Cancer Center Warrenville

    RECRUITING

    Warrenville, Illinois, 60555, United States

  • Northwestern Medicine Glenview Outpatient Center

    RECRUITING

    Glenview, Illinois, 60026, United States

  • Northwestern Medicine Grayslake Outpatient Center

    RECRUITING

    Grayslake, Illinois, 60030, United States

  • Northwestern Medicine Lake Forest Hospital

    RECRUITING

    Lake Forest, Illinois, 60045, United States

    Contact Email: •••••@•••••

  • Northwestern Medicine Oak Brook

    RECRUITING

    Oak Brook, Illinois, 60523, United States

  • Northwestern Medicine Orland Park

    RECRUITING

    Orland Park, Illinois, 60462, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • Our Lady of The Lake

    RECRUITING

    Baton Rouge, Louisiana, 70808, United States

  • Our Lady of the Lake Physician Group

    RECRUITING

    Baton Rouge, Louisiana, 70808, United States

    Contact Email: •••••@•••••

  • ProMedica Flower Hospital

    RECRUITING

    Sylvania, Ohio, 43560, United States

    Contact Email: •••••@•••••

  • Providence Newberg Medical Center

    SUSPENDED

    Newberg, Oregon, 97132, United States

  • Providence Portland Medical Center

    RECRUITING

    Portland, Oregon, 97213, United States

    Contact Email: •••••@•••••

  • Providence Saint Vincent Medical Center

    RECRUITING

    Portland, Oregon, 97225, United States

    Contact Email: •••••@•••••

  • Providence Willamette Falls Medical Center

    SUSPENDED

    Oregon City, Oregon, 97045, United States

  • Rush MD Anderson Cancer Center

    RECRUITING

    Chicago, Illinois, 60612, United States

    Contact Email: •••••@•••••

  • Rush MD Anderson Cancer Center at Rush Lisle

    RECRUITING

    Lisle, Illinois, 60532, United States

    Contact Email: •••••@•••••

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • Rutgers New Jersey Medical School

    RECRUITING

    Newark, New Jersey, 07101, United States

  • Saint Vincent Hospital

    RECRUITING

    Erie, Pennsylvania, 16544, United States

  • Siteman Cancer Center at Christian Hospital

    RECRUITING

    St Louis, Missouri, 63136, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center at Saint Peters Hospital

    RECRUITING

    City of Saint Peters, Missouri, 63376, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center at West County Hospital

    RECRUITING

    Creve Coeur, Missouri, 63141, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center-South County

    RECRUITING

    St Louis, Missouri, 63129, United States

    Contact Email: •••••@•••••

  • Stanford Cancer Institute Palo Alto

    RECRUITING

    Palo Alto, California, 94304, United States

    Contact Email: •••••@•••••

  • Stony Brook University Medical Center

    RECRUITING

    Stony Brook, New York, 11794, United States

  • Sutter Medical Center Sacramento

    RECRUITING

    Sacramento, California, 95816, United States

    Contact Email: •••••@•••••

  • Thomas Jefferson University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

    Contact Email: •••••@•••••

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    RECRUITING

    Ankeny, Iowa, 50023, United States

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

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    RECRUITING

    Des Moines, Iowa, 50314, United States

  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    RECRUITING

    Waukee, Iowa, 50263, United States

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

    RECRUITING

    Clive, Iowa, 50325, United States

  • UNC Lineberger Comprehensive Cancer Center

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

    Contact Email: •••••@•••••

  • UPMC Cancer Center - Monroeville

    RECRUITING

    Monroeville, Pennsylvania, 15146, United States

  • UPMC Cancer Center at UPMC Horizon

    RECRUITING

    Farrell, Pennsylvania, 16121, United States

  • UPMC Cancer Center at UPMC Northwest

    RECRUITING

    Seneca, Pennsylvania, 16346, United States

  • UPMC Cancer Center-Washington

    RECRUITING

    Washington, Pennsylvania, 15301, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • UPMC Hillman Cancer Center - Monroeville

    RECRUITING

    Monroeville, Pennsylvania, 15146, United States

    Contact Email: •••••@•••••

  • UPMC Hillman Cancer Center Erie

    RECRUITING

    Erie, Pennsylvania, 16505, United States

    Contact Email: •••••@•••••

  • UPMC Washington Hospital Radiation Oncology

    RECRUITING

    Washington, Pennsylvania, 15301, United States

    Contact Email: •••••@•••••

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

    RECRUITING

    Johnstown, Pennsylvania, 15901, United States

  • UPMC-Saint Clair Hospital Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15243, United States

  • UPMC-Saint Margaret

    RECRUITING

    Pittsburgh, Pennsylvania, 15215, United States

  • UPMC-Shadyside Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • USC / Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Arizona Cancer Center-North Campus

    RECRUITING

    Tucson, Arizona, 85719, United States

  • University of California Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Kansas Cancer Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Kansas Cancer Center - Briarcliff

    RECRUITING

    Kansas City, Missouri, 64116, United States

  • University of Kansas Cancer Center - Lee's Summit

    RECRUITING

    Lee's Summit, Missouri, 64064, United States

  • University of Kansas Cancer Center - North

    RECRUITING

    Kansas City, Missouri, 64154, United States

  • University of Kansas Cancer Center-Overland Park

    RECRUITING

    Overland Park, Kansas, 66210, United States

  • University of Kansas Hospital-Westwood Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of Michigan - Brighton Center for Specialty Care

    RECRUITING

    Brighton, Michigan, 48116, United States

  • University of Michigan Rogel Cancer Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

    Contact Email: •••••@•••••

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    RECRUITING

    Madison, Wisconsin, 53718, United States

    Contact Email: •••••@•••••

  • University of Wisconsin Carbone Cancer Center - Johnson Creek

    RECRUITING

    Johnson Creek, Wisconsin, 53038, United States

    Contact Email: •••••@•••••

  • University of Wisconsin Carbone Cancer Center - University Hospital

    RECRUITING

    Madison, Wisconsin, 53792, United States

    Contact Email: •••••@•••••

  • Vanderbilt University/Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

    Contact Email: •••••@•••••

  • Wayne State University/Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

    Contact Email: •••••@•••••

  • Weisberg Cancer Treatment Center

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

    Contact Email: •••••@•••••

  • Wexford Health and Wellness Pavilion

    RECRUITING

    Wexford, Pennsylvania, 15090, United States

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