Actively Recruiting
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
180
Participants Needed
48
Research Sites
353 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of locally recurrent or persistent squamous cell carcinoma of the head and neck in the oral cavity, oropharynx, larynx, or hypopharynx
- PD-L1 combined positive score of 1 or higher
- Verified insurance coverage for neoadjuvant chemotherapy
- Measurable disease by RECIST 1.1 criteria
- Candidates for salvage surgery with specified tumor and nodal stages
- Surgically resectable disease without gross residual tumor
- For oral cavity cancer, recurrence or persistence after prior surgery
- Candidates for salvage laryngectomy with curative intent
- Resectable lymph node-only recurrence
- No major vascular involvement or involvement that precludes curative surgery
- No distant metastatic disease
- Required diagnostic workup including history, physical exam, neck CT, and PET/CT
- Age 18 years or older
- ECOG performance status 0-2
- Negative pregnancy test if of childbearing potential
- Adequate blood counts (ANC ≥ 1,500, platelets ≥ 100,000, hemoglobin ≥ 8.0 g/dL)
- Adequate kidney function (creatinine clearance > 50 mL/min)
- Liver function within specified limits
- Prior radiation therapy completed at least 6 months before registration
- Prior immunotherapy within definitive setting allowed if completed at least 4 months prior
- No prior immunotherapy for recurrent or metastatic disease
- No investigational anti-cancer agents within 4 weeks prior to registration
- No heart failure classified as NYHA class III or IV
- No active infections requiring IV treatment
- No severe peripheral neuropathy (grade 3 or 4)
- No history of allergic reactions to study agents or similar drugs
You will not qualify if you...
- Evidence of distant metastatic disease
- Prior immunotherapy for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck
- Use of investigational anti-cancer agents within 4 weeks prior to registration
- New York Heart Association Functional Classification III or IV heart disease
- Active infection requiring intravenous antibiotics, antivirals, or antifungals
- Peripheral neuropathy grade 3 or 4
- History of allergic reaction to study drugs or similar compounds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 48 locations
1
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
Actively Recruiting
2
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
Actively Recruiting
3
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
4
Sutter Medical Center Sacramento
Sacramento, California, United States, 95816
Actively Recruiting
5
Emory Proton Therapy Center
Atlanta, Georgia, United States, 30308
Actively Recruiting
6
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
7
Rush MD Anderson Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
8
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States, 50023
Actively Recruiting
9
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States, 50325
Actively Recruiting
10
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, United States, 51503
Suspended
11
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Actively Recruiting
12
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States, 50309
Actively Recruiting
13
Broadlawns Medical Center
Des Moines, Iowa, United States, 50314
Actively Recruiting
14
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Actively Recruiting
15
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States, 50314
Actively Recruiting
16
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States, 50263
Actively Recruiting
17
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
18
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
19
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
20
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, United States, 70805
Actively Recruiting
21
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
22
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
23
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan, United States, 48116
Actively Recruiting
24
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
25
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, United States, 64116
Actively Recruiting
26
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Actively Recruiting
27
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
28
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha, Nebraska, United States, 68114
Actively Recruiting
29
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
Actively Recruiting
30
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Actively Recruiting
31
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Actively Recruiting
32
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Actively Recruiting
33
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Actively Recruiting
34
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
Actively Recruiting
35
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
36
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
37
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
Actively Recruiting
38
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
39
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States, 19090
Actively Recruiting
40
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington, United States, 98684
Actively Recruiting
41
Legacy Salmon Creek Hospital
Vancouver, Washington, United States, 98686
Actively Recruiting
42
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States, 53718
Actively Recruiting
43
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
44
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, United States, 53051
Actively Recruiting
45
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
46
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, United States, 53151
Actively Recruiting
47
Drexel Town Square Health Center
Oak Creek, Wisconsin, United States, 53154
Actively Recruiting
48
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, United States, 53095
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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