NCT07195734RecruitingPhase 2
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
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)
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 26 Sept 2025
- Start date
- 24 Apr 2026
- Primary completion date
- 1 Feb 2033
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Head and neck cancer
- NCT number
- NCT07195734
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 180
- From 24 Apr 2026 to the primary completion date, 1 Feb 2033
- 115 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (115)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Coordinator of this site? Confirm its status | Ankeny | United States | Recruiting |
| University of Michigan Rogel Cancer Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Emory Proton Therapy Center Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory University Hospital Midtown Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| LSU Health Baton Rouge-North Clinic Coordinator of this site? Confirm its status | Baton Rouge | United States | Recruiting |
| Our Lady of The Lake Coordinator of this site? Confirm its status | Baton Rouge | United States | Recruiting |
| Our Lady of the Lake Physician Group Coordinator of this site? Confirm its status | Baton Rouge | United States | Recruiting |
| Lafayette Family Cancer Center-EMMC Coordinator of this site? Confirm its status | Brewer | United States | Recruiting |
| University of Michigan - Brighton Center for Specialty Care Coordinator of this site? Confirm its status | Brighton | United States | Recruiting |
| Cooper Hospital University Medical Center Coordinator of this site? Confirm its status | Camden | United States | Recruiting |
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Carolinas Medical Center/Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Rush MD Anderson Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Siteman Cancer Center at Saint Peters Hospital Coordinator of this site? Confirm its status | City of Saint Peters | United States | Recruiting |
| Clackamas Radiation Oncology Center Coordinator of this site? Confirm its status | Clackamas | United States | Recruiting |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Coordinator of this site? Confirm its status | Clive | United States | Recruiting |
| Atrium Health Cabarrus/LCI-Concord Coordinator of this site? Confirm its status | Concord | United States | Recruiting |
| Methodist Jennie Edmundson Hospital Coordinator of this site? Confirm its status | Council Bluffs | United States | Suspended |
| Siteman Cancer Center at West County Hospital Coordinator of this site? Confirm its status | Creve Coeur | United States | Recruiting |
| Carle at The Riverfront Coordinator of this site? Confirm its status | Danville | United States | Recruiting |
| Northwestern Medicine Cancer Center Kishwaukee Coordinator of this site? Confirm its status | DeKalb | United States | Recruiting |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Coordinator of this site? Confirm its status | Des Moines | United States | Recruiting |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Coordinator of this site? Confirm its status | Des Moines | United States | Recruiting |
| Broadlawns Medical Center Coordinator of this site? Confirm its status | Des Moines | United States | Recruiting |
| Mercy Medical Center - Des Moines Coordinator of this site? Confirm its status | Des Moines | United States | Recruiting |
| Iowa Methodist Medical Center Coordinator of this site? Confirm its status | Des Moines | United States | Recruiting |
| Wayne State University/Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Carle Physician Group-Effingham Coordinator of this site? Confirm its status | Effingham | United States | Recruiting |
| Saint Vincent Hospital Coordinator of this site? Confirm its status | Erie | United States | Recruiting |
| UPMC Hillman Cancer Center Erie Coordinator of this site? Confirm its status | Erie | United States | Recruiting |
| Weisberg Cancer Treatment Center Coordinator of this site? Confirm its status | Farmington Hills | United States | Recruiting |
| UPMC Cancer Center at UPMC Horizon Coordinator of this site? Confirm its status | Farrell | United States | Recruiting |
| Northwestern Medicine Cancer Center Delnor Coordinator of this site? Confirm its status | Geneva | United States | Recruiting |
| Northwestern Medicine Glenview Outpatient Center Coordinator of this site? Confirm its status | Glenview | United States | Recruiting |
| Northwestern Medicine Grayslake Outpatient Center Coordinator of this site? Confirm its status | Grayslake | United States | Recruiting |
| Legacy Mount Hood Medical Center Coordinator of this site? Confirm its status | Gresham | United States | Recruiting |
| IRMC Cancer Center Coordinator of this site? Confirm its status | Indiana | United States | Recruiting |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Recruiting |
| Jefferson Hospital Coordinator of this site? Confirm its status | Jefferson Hills | United States | Recruiting |
| Jersey City Medical Center Coordinator of this site? Confirm its status | Jersey City | United States | Recruiting |
| University of Wisconsin Carbone Cancer Center - Johnson Creek Coordinator of this site? Confirm its status | Johnson Creek | United States | Recruiting |
| UPMC-Johnstown/John P. Murtha Regional Cancer Center Coordinator of this site? Confirm its status | Johnstown | United States | Recruiting |
| University of Kansas Cancer Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| University of Kansas Cancer Center - North Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| University of Kansas Cancer Center - Briarcliff Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Gundersen Lutheran Medical Center Coordinator of this site? Confirm its status | La Crosse | United States | Recruiting |
| Northwestern Medicine Lake Forest Hospital Coordinator of this site? Confirm its status | Lake Forest | United States | Recruiting |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Coordinator of this site? Confirm its status | Lebanon | United States | Recruiting |
| University of Kansas Cancer Center - Lee's Summit Coordinator of this site? Confirm its status | Lee's Summit | United States | Recruiting |
| Rush MD Anderson Cancer Center at Rush Lisle Coordinator of this site? Confirm its status | Lisle | United States | Recruiting |
| Cooperman Barnabas Medical Center Coordinator of this site? Confirm its status | Livingston | United States | Recruiting |
| Monmouth Medical Center Coordinator of this site? Confirm its status | Long Branch | United States | Recruiting |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| University of Wisconsin Carbone Cancer Center - University Hospital Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| Carle Physician Group-Mattoon/Charleston Coordinator of this site? Confirm its status | Mattoon | United States | Recruiting |
| Froedtert Menomonee Falls Hospital Coordinator of this site? Confirm its status | Menomonee Falls | United States | Recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Forbes Hospital Coordinator of this site? Confirm its status | Monroeville | United States | Recruiting |
| UPMC Hillman Cancer Center - Monroeville Coordinator of this site? Confirm its status | Monroeville | United States | Recruiting |
| UPMC Cancer Center - Monroeville Coordinator of this site? Confirm its status | Monroeville | United States | Recruiting |
| Vanderbilt University/Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Rutgers New Jersey Medical School Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Providence Newberg Medical Center Coordinator of this site? Confirm its status | Newberg | United States | Recruiting |
| Froedtert and MCW Moorland Reserve Health Center Coordinator of this site? Confirm its status | New Berlin | United States | Recruiting |
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
| Northwestern Medicine Oak Brook Coordinator of this site? Confirm its status | Oak Brook | United States | Recruiting |
| Drexel Town Square Health Center Coordinator of this site? Confirm its status | Oak Creek | United States | Recruiting |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Nebraska Cancer Specialists/Oncology Hematology West PC - MECC Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Nebraska Methodist Hospital Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| UC Irvine Health- Chao Family Comprehensive Cancer Center Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Providence Willamette Falls Medical Center Coordinator of this site? Confirm its status | Oregon City | United States | Recruiting |
| Northwestern Medicine Orland Park Coordinator of this site? Confirm its status | Orland Park | United States | Recruiting |
| University of Kansas Cancer Center-Overland Park Coordinator of this site? Confirm its status | Overland Park | United States | Recruiting |
| Stanford Cancer Institute Palo Alto Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Thomas Jefferson University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| UPMC-Shadyside Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| UPMC-Saint Clair Hospital Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Allegheny General Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| UPMC-Saint Margaret Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Providence Portland Medical Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Providence Saint Vincent Medical Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Legacy Good Samaritan Hospital and Medical Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Sutter Medical Center Sacramento Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| University of California Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| UPMC Cancer Center at UPMC Northwest Coordinator of this site? Confirm its status | Seneca | United States | Recruiting |
| Memorial Hospital East Coordinator of this site? Confirm its status | Shiloh | United States | Recruiting |
| Siteman Cancer Center at Christian Hospital Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Siteman Cancer Center-South County Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Stony Brook University Medical Center Coordinator of this site? Confirm its status | Stony Brook | United States | Recruiting |
| ProMedica Flower Hospital Coordinator of this site? Confirm its status | Sylvania | United States | Recruiting |
| Community Medical Center Coordinator of this site? Confirm its status | Toms River | United States | Recruiting |
| Legacy Meridian Park Hospital Coordinator of this site? Confirm its status | Tualatin | United States | Recruiting |
| University of Arizona Cancer Center-North Campus Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
| Banner University Medical Center - Tucson Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
| Carle Cancer Center Coordinator of this site? Confirm its status | Urbana | United States | Recruiting |
| Legacy Salmon Creek Hospital Coordinator of this site? Confirm its status | Vancouver | United States | Recruiting |
| Legacy Cancer Institute Medical Oncology and Day Treatment Coordinator of this site? Confirm its status | Vancouver | United States | Recruiting |
| Northwestern Medicine Cancer Center Warrenville Coordinator of this site? Confirm its status | Warrenville | United States | Recruiting |
| UPMC Cancer Center-Washington Coordinator of this site? Confirm its status | Washington | United States | Recruiting |
| UPMC Washington Hospital Radiation Oncology Coordinator of this site? Confirm its status | Washington | United States | Recruiting |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Coordinator of this site? Confirm its status | Waukee | United States | Recruiting |
| Wilmot Cancer Institute at Webster Coordinator of this site? Confirm its status | Webster | United States | Recruiting |
| Froedtert West Bend Hospital/Kraemer Cancer Center Coordinator of this site? Confirm its status | West Bend | United States | Recruiting |
| University of Kansas Hospital-Westwood Cancer Center Coordinator of this site? Confirm its status | Westwood | United States | Recruiting |
| Wexford Health and Wellness Pavilion Coordinator of this site? Confirm its status | Wexford | United States | Recruiting |
| Asplundh Cancer Pavilion Coordinator of this site? Confirm its status | Willow Grove | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.