Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
Public ClinicalTrials.gov record NCT07195734. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07195734
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 180 participants
Conditions and interventions
Conditions
- Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Locally Recurrent Head and Neck Squamous Cell Carcinoma
- Locally Recurrent Hypopharyngeal Squamous Cell Carcinoma
- Locally Recurrent Laryngeal Squamous Cell Carcinoma
- Locally Recurrent Oral Cavity Squamous Cell Carcinoma
- Locally Recurrent Oropharyngeal Squamous Cell Carcinoma
- Stage II Laryngeal Cancer AJCC v8
- Stage II Lip and Oral Cavity Cancer AJCC v8
- Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage III Laryngeal Cancer AJCC v8
- Stage III Lip and Oral Cavity Cancer AJCC v8
- Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVA Laryngeal Cancer AJCC v8
- Stage IVA Lip and Oral Cavity Cancer AJCC v8
- Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVB Laryngeal Cancer AJCC v8
- Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Interventions
- Biospecimen Collection Procedure
- Carboplatin Drug
- Cemiplimab Biological
- Cisplatin Drug
- Computed Tomography Procedure
- Paclitaxel Drug
- Positron Emission Tomography Procedure
- Radiation Therapy Radiation
- Salvage Surgery Procedure
Procedure · Drug · Biological + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 24, 2026 (Actual)
- Primary completion
- Feb 1, 2033 (Estimated)
- Completion
- Feb 1, 2033 (Estimated)
- Last update posted
- Oct 14, 2026
2026 – 2033
United States locations
- U.S. sites
- 113
- U.S. states
- 24
- U.S. cities
- 86
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner University Medical Center - Tucson | Tucson | Arizona | 85719 | Recruiting |
| University of Arizona Cancer Center-North Campus | Tucson | Arizona | 85719 | Recruiting |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Recruiting |
| Stanford Cancer Institute Palo Alto | Palo Alto | California | 94304 | Recruiting |
| Sutter Medical Center Sacramento | Sacramento | California | 95816 | Recruiting |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | Recruiting |
| Emory Proton Therapy Center | Atlanta | Georgia | 30308 | Recruiting |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | Recruiting |
| Northwestern University | Chicago | Illinois | 60611 | Recruiting |
| Rush MD Anderson Cancer Center | Chicago | Illinois | 60612 | Recruiting |
| Carle at The Riverfront | Danville | Illinois | 61832 | Recruiting |
| Northwestern Medicine Cancer Center Kishwaukee | DeKalb | Illinois | 60115 | Recruiting |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | Recruiting |
| Northwestern Medicine Cancer Center Delnor | Geneva | Illinois | 60134 | Recruiting |
| Northwestern Medicine Glenview Outpatient Center | Glenview | Illinois | 60026 | Recruiting |
| Northwestern Medicine Grayslake Outpatient Center | Grayslake | Illinois | 60030 | Recruiting |
| Northwestern Medicine Lake Forest Hospital | Lake Forest | Illinois | 60045 | Recruiting |
| Rush MD Anderson Cancer Center at Rush Lisle | Lisle | Illinois | 60532 | Recruiting |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | 61938 | Recruiting |
| Northwestern Medicine Oak Brook | Oak Brook | Illinois | 60523 | Recruiting |
| Northwestern Medicine Orland Park | Orland Park | Illinois | 60462 | Recruiting |
| Memorial Hospital East | Shiloh | Illinois | 62269 | Recruiting |
| Carle Cancer Center | Urbana | Illinois | 61801 | Recruiting |
| Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois | 60555 | Recruiting |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | Ankeny | Iowa | 50023 | Recruiting |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic | Clive | Iowa | 50325 | Recruiting |
| Methodist Jennie Edmundson Hospital | Council Bluffs | Iowa | 51503 | Suspended |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | Recruiting |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic | Des Moines | Iowa | 50309 | Recruiting |
| Broadlawns Medical Center | Des Moines | Iowa | 50314 | Recruiting |
| Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | Recruiting |
| UI Health Care Mission Cancer and Blood - Laurel Clinic | Des Moines | Iowa | 50314 | Recruiting |
| UI Health Care Mission Cancer and Blood - Waukee Clinic | Waukee | Iowa | 50263 | Recruiting |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | Recruiting |
| University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | 66210 | Recruiting |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | 66205 | Recruiting |
| LSU Health Baton Rouge-North Clinic | Baton Rouge | Louisiana | 70805 | Recruiting |
| Our Lady of the Lake Physician Group | Baton Rouge | Louisiana | 70808 | Recruiting |
| Our Lady of The Lake | Baton Rouge | Louisiana | 70808 | Recruiting |
| Lafayette Family Cancer Center-EMMC | Brewer | Maine | 04412 | Recruiting |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | Recruiting |
| University of Michigan - Brighton Center for Specialty Care | Brighton | Michigan | 48116 | Recruiting |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | Recruiting |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Recruiting |
| Weisberg Cancer Treatment Center | Farmington Hills | Michigan | 48334 | Recruiting |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | Recruiting |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | Recruiting |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | Recruiting |
| University of Kansas Cancer Center - Briarcliff | Kansas City | Missouri | 64116 | Recruiting |
| University of Kansas Cancer Center - North | Kansas City | Missouri | 64154 | Recruiting |
| University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | 64064 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | Recruiting |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | Recruiting |
| Nebraska Cancer Specialists/Oncology Hematology West PC - MECC | Omaha | Nebraska | 68114 | Recruiting |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | Recruiting |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | Recruiting |
| Cooper Hospital University Medical Center | Camden | New Jersey | 08103 | Recruiting |
| Jersey City Medical Center | Jersey City | New Jersey | 07302 | Recruiting |
| Cooperman Barnabas Medical Center | Livingston | New Jersey | 07039 | Recruiting |
| Monmouth Medical Center | Long Branch | New Jersey | 07740 | Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | Recruiting |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07101 | Recruiting |
| Community Medical Center | Toms River | New Jersey | 08755 | Recruiting |
| University of Rochester | Rochester | New York | 14642 | Recruiting |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | Recruiting |
| Wilmot Cancer Institute at Webster | Webster | New York | 14580 | Recruiting |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | Recruiting |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | Recruiting |
| Atrium Health Cabarrus/LCI-Concord | Concord | North Carolina | 28025 | Recruiting |
| ProMedica Flower Hospital | Sylvania | Ohio | 43560 | Recruiting |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Clackamas Radiation Oncology Center | Clackamas | Oregon | 97015 | Recruiting |
| Legacy Mount Hood Medical Center | Gresham | Oregon | 97030 | Recruiting |
| Providence Newberg Medical Center | Newberg | Oregon | 97132 | Recruiting |
| Providence Willamette Falls Medical Center | Oregon City | Oregon | 97045 | Recruiting |
| Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon | 97210 | Recruiting |
| Providence Portland Medical Center | Portland | Oregon | 97213 | Recruiting |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | Recruiting |
| Legacy Meridian Park Hospital | Tualatin | Oregon | 97062 | Recruiting |
| UPMC Hillman Cancer Center Erie | Erie | Pennsylvania | 16505 | Recruiting |
| Saint Vincent Hospital | Erie | Pennsylvania | 16544 | Recruiting |
| UPMC Cancer Center at UPMC Horizon | Farrell | Pennsylvania | 16121 | Recruiting |
| IRMC Cancer Center | Indiana | Pennsylvania | 15701 | Recruiting |
| Jefferson Hospital | Jefferson Hills | Pennsylvania | 15025 | Recruiting |
| UPMC-Johnstown/John P. Murtha Regional Cancer Center | Johnstown | Pennsylvania | 15901 | Recruiting |
| Forbes Hospital | Monroeville | Pennsylvania | 15146 | Recruiting |
| UPMC Cancer Center - Monroeville | Monroeville | Pennsylvania | 15146 | Recruiting |
| UPMC Hillman Cancer Center - Monroeville | Monroeville | Pennsylvania | 15146 | Recruiting |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | Recruiting |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | Recruiting |
| UPMC-Saint Margaret | Pittsburgh | Pennsylvania | 15215 | Recruiting |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| UPMC-Shadyside Hospital | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| UPMC-Saint Clair Hospital Cancer Center | Pittsburgh | Pennsylvania | 15243 | Recruiting |
| UPMC Cancer Center at UPMC Northwest | Seneca | Pennsylvania | 16346 | Recruiting |
| UPMC Cancer Center-Washington | Washington | Pennsylvania | 15301 | Recruiting |
| UPMC Washington Hospital Radiation Oncology | Washington | Pennsylvania | 15301 | Recruiting |
| Wexford Health and Wellness Pavilion | Wexford | Pennsylvania | 15090 | Recruiting |
| Asplundh Cancer Pavilion | Willow Grove | Pennsylvania | 19090 | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Recruiting |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | Recruiting |
| Legacy Cancer Institute Medical Oncology and Day Treatment | Vancouver | Washington | 98684 | Recruiting |
| Legacy Salmon Creek Hospital | Vancouver | Washington | 98686 | Recruiting |
| University of Wisconsin Carbone Cancer Center - Johnson Creek | Johnson Creek | Wisconsin | 53038 | Recruiting |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | Recruiting |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center | Madison | Wisconsin | 53718 | Recruiting |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | Recruiting |
| Froedtert Menomonee Falls Hospital | Menomonee Falls | Wisconsin | 53051 | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Recruiting |
| Froedtert and MCW Moorland Reserve Health Center | New Berlin | Wisconsin | 53151 | Recruiting |
| Drexel Town Square Health Center | Oak Creek | Wisconsin | 53154 | Recruiting |
| Froedtert West Bend Hospital/Kraemer Cancer Center | West Bend | Wisconsin | 53095 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07195734, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2026 · Synced Oct 16, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07195734 live on ClinicalTrials.gov.