Actively Recruiting
A Phase II Randomized Trial of Neoadjuvant Chemotherapy or Chemo-Immunotherapy in Patients With Recurrent or Persistent PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck Undergoing Salvage Surgery
Led by National Cancer Institute (NCI) ยท Updated on 2026-05-19
180
Participants Needed
51
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients with PD-L1 positive head and neck squamous cell carcinoma that has returned or persisted after initial improvement. This phase II trial compares the effects of adding chemotherapy or chemo-immunotherapy to the usual salvage surgery followed by radiation and cisplatin treatment. The goal is to see if these combinations can better control the cancer in high-risk patients. Participants are randomly assigned to one of three groups. One group receives standard salvage surgery followed by radiation and weekly cisplatin if high-risk features are present. The second group receives chemotherapy with carboplatin and paclitaxel before surgery, followed by radiation and cisplatin. The third group receives chemo-immunotherapy with carboplatin, paclitaxel, and cemiplimab before surgery, then radiation and cisplatin. Treatments are given in cycles every 21 days for two cycles before surgery, with follow-up care extending beyond the initial treatment. Throughout the study, patients undergo CT and PET scans and may give blood samples to monitor their condition. Follow-up visits occur at 12 weeks after treatment and then every few months for up to several years to assess event-free survival, disease recurrence, overall survival, and any side effects or surgical complications. The study aims to understand the impact of these treatment combinations on cancer outcomes and patient safety over time.
CONDITIONS
Brief 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
- Measurable disease according to RECIST 1.1 criteria
- Candidates for salvage surgery without gross residual disease
- Prior radiation therapy completed at least 6 months before registration with majority of cancer volume irradiated
- Age 18 years or older
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Negative pregnancy test for persons of childbearing potential within 30 days prior to registration
- Adequate blood counts and organ function as defined by study criteria
- Prior systemic therapy including immunotherapy completed at least 4 months before registration
- Insurance or payment coverage verified for neoadjuvant chemotherapy
- No investigational anti-cancer agents within 4 weeks prior to registration
You will not qualify if you...
- Evidence of distant metastatic disease
- Major vascular involvement or areas precluding curative resection
- Prior systemic therapy with immunotherapy for recurrent or metastatic disease
- New York Heart Association Functional Classification III or IV heart disease
- Active infections requiring intravenous antibiotics, antivirals, or antifungals
- Peripheral neuropathy grade 3 or 4
- History of allergic reaction to study agents or similar compounds
- More than one prior course of radiation therapy
- Inability to undergo required diagnostic imaging or assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 4 months including pre-surgery treatment, surgery, and post-surgery radiation
Participants receive assigned therapy, which may include chemotherapy, chemo-immunotherapy, or standard salvage surgery. Chemotherapy and chemo-immunotherapy are given in 2 cycles every 21 days before surgery. Surgery is performed 6 to 10 weeks after starting treatment. High risk participants may also receive radiation therapy and weekly cisplatin for 6 weeks after surgery.
2 chemotherapy or chemo-immunotherapy cycles (every 3 weeks), 1 salvage surgery visit, followed by radiation therapy with weekly visits for 6 weeks if applicable
Duration - Up to 7 years
Participants are monitored after treatment completion with scheduled visits to assess health status and detect any recurrence. Follow-up visits occur regularly for up to 7 years.
Visits at 12 weeks or end of radiation, then every 3 months for 2 years, every 6 months for years 3 and 4, and annually thereafter
Trial Site Locations
Total: 51 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
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
31
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Actively Recruiting
32
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Actively Recruiting
33
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Actively Recruiting
34
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Actively Recruiting
35
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
Actively Recruiting
36
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
37
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
38
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
Actively Recruiting
39
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
40
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States, 19090
Actively Recruiting
41
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
42
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
43
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington, United States, 98684
Actively Recruiting
44
Legacy Salmon Creek Hospital
Vancouver, Washington, United States, 98686
Actively Recruiting
45
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States, 53718
Actively Recruiting
46
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
47
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, United States, 53051
Actively Recruiting
48
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
49
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, United States, 53151
Actively Recruiting
50
Drexel Town Square Health Center
Oak Creek, Wisconsin, United States, 53154
Actively Recruiting
51
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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