Comparing an immunotherapy drug to chemotherapy and radiation for recurrent head and neck cancer after surgery
Official title: A Phase II Randomized Trial of Adjuvant Therapy With Pembrolizumab After Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma With High Risk Features
Run by National Cancer Institute (NCI) · NCT04671667 · Data updated 2026-11-12
This study is testing whether an immunotherapy drug called pembrolizumab can help people with recurrent head and neck cancer live longer compared to the usual treatment of chemotherapy and radiation.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Enrollment | 188 (estimated) |
| Sponsor | National Cancer Institute (NCI) NIH |
| Drugs / interventions | pembrolizumab, chemotherapy, radiation, prednisone, Immunotherapy |
| Locations | 178 sites (Birmingham, Alabama and 177 other locations) |
| Status | Recruiting |
| Started | April 27, 2021 |
| Main results expected | June 30, 2029 |
| Study ends | June 30, 2029 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT04671667 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 79 with locoregionally recurrent or second primary head and neck squamous cell carcinoma who have undergone surgery and have high-risk disease characteristics.
✕Probably not a fit
Patients with low PD-L1 expression or those who have not undergone the required surgical procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II trial evaluates the effectiveness of pembrolizumab, an immunotherapy drug, compared to the standard treatment of chemotherapy combined with radiation therapy in patients with recurrent head and neck squamous cell carcinoma. Patients will be randomized into two groups: one receiving pembrolizumab and the other receiving cisplatin or carboplatin along with radiation therapy. The primary goal is to assess overall survival, while secondary objectives include evaluating disease-free survival, locoregional control, and toxicity levels. Patients will be monitored through imaging techniques throughout the trial and followed up for up to five years post-treatment.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with recurrent head and neck cancer, potentially improving survival rates.
How similar studies have gone: Other studies have shown promise with immunotherapy approaches in similar cancer types, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patient must be between 18 and 79 years of age
* Patient must have locoregionally recurrent or second primary HNSCC (oral cavity, oropharynx, larynx, hypopharynx) in a previously radiated field
* Patient must have undergone surgery with gross total resection and must be randomized within 8 weeks of surgery
* Patients must have high risk disease defined as:
* Positive margins and/or extra nodal extension (ENE)
* Positive margins are defined as malignancy at or within 1 mm of the margin. High grade dysplasia (i.e. carcinoma in situ) at the margin is also considered positive
* ENE may be either gross or microscopic
* Patient must have a PD-L1 Combined Positive Score (CPS) \>= 1 in a Clinical Laboratory Improvement Act (CLIA) certified laboratory. Testing can be done locally as long as it is done in a CLIA certified laboratory. This testing must be on the tumor specimen from the resection of the patient's recurrent or second primary HNSCC
* Patient must have had prior radiation to the area of recurrent or second primary tumor. This is defined as \> 50% of the presurgical tumor volume having previously received a dose of \> 45 Gy as determined by the treating radiation oncologist
* Patient must have completed prior radiation a minimum of 6 months prior to randomization
* Patient must not have any evidence of distant disease based on baseline imaging done within 28 days prior to randomization
* Patient must not have received anti-PD-1/PD-L1 therapy for recurrent disease. If the patient received anti-PD-1/PD-L1 therapy as part of initial upfront curative intent treatment (either as part of definitive non-surgical therapy or in the adjuvant setting) in the past, the last dosage of anti-PD-1/PD-L1 therapy must have been given greater than one year prior to randomization
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A urine or serum pregnancy test must be repeated within 72 hours prior to receiving the first dose of pembrolizumab or chemotherapy if the test done for eligibility/randomization is done outside of this 72 hour window. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. A patient of childbearing potential is someone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Patient must not expect to conceive or father children by using by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse while on study treatment, and continue for 120 days after the last dose of study treatment
* Absolute neutrophil count (ANC) \>= 1,500/mcL (obtained =\< 28 days prior to protocol randomization)
* Platelets \>= 100,000/mcL (obtained =\< 28 days prior to protocol randomization)
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (obtained =\< 28 days prior to protocol randomization)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 3.0 x institutional ULN (obtained =\< 28 days prior to protocol randomization)
* Creatinine clearance \> 30 ml/min using the Cockcroft-Gault formula (obtained =\< 28 days prior to protocol randomization)
* Patient must not have a current active infection that requires systemic treatment at time of randomization
* Patient must not have a history of non-infectious pneumonitis requiring steroids within 3 years prior to randomization
* Patient must not have a history of solid organ transplant or stem cell transplant
* Patient must not be on immunosuppressive medication within 7 days prior to randomization, EXCEPT for the following: a) intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b) systemic corticosteroids at physiologic doses =\< 10 mg/day of prednisone or equivalent; c) steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
* 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. Patients with New York Heart Association class III or IV heart failure are not eligible
* Patient must not have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed
* Patient must not have severe hypersensitivity (\>= grade 3) to pembrolizumab and/or any of its excipients
* Patient must not have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
* Patient must not have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial as long as they have not been HIV-infected with a history of Kaposi sarcoma and/or multicentric Castleman disease
* Patient must not have a known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid \[RNA\] \[qualitative\] is detected) infection
* NOTE: No testing for hepatitis B and hepatitis C is required unless mandated by a local health authority
Where it's running
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States Recruiting -
Kaiser Permanente-Anaheim
Anaheim, California, United States Recruiting -
Kaiser Permanente-Bellflower
Bellflower, California, United States Recruiting -
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States Recruiting -
Kaiser Permanente-Ontario
Ontario, California, United States Recruiting -
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, United States Recruiting
Show 44 more locations
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Yale University
New Haven, Connecticut, United States Recruiting -
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States Recruiting -
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States Recruiting -
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States Recruiting -
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States Recruiting -
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States Recruiting -
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States Recruiting -
Moffitt Cancer Center
Tampa, Florida, United States Recruiting -
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, United States Recruiting -
Emory Proton Therapy Center
Atlanta, Georgia, United States Recruiting -
Emory University Hospital Midtown
Atlanta, Georgia, United States Recruiting -
Northwestern University
Chicago, Illinois, United States Recruiting -
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States Recruiting -
University of Illinois
Chicago, Illinois, United States Recruiting -
Carle at The Riverfront
Danville, Illinois, United States Recruiting -
Decatur Memorial Hospital
Decatur, Illinois, United States Recruiting -
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States Recruiting -
Carle Physician Group-Effingham
Effingham, Illinois, United States Recruiting -
Crossroads Cancer Center
Effingham, Illinois, United States Recruiting -
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States Recruiting -
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States Recruiting -
Loyola University Medical Center
Maywood, Illinois, United States Recruiting -
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, United States Recruiting -
Southern Illinois University School of Medicine
Springfield, Illinois, United States Recruiting -
Springfield Clinic
Springfield, Illinois, United States Recruiting -
Springfield Memorial Hospital
Springfield, Illinois, United States Recruiting -
Carle Cancer Center
Urbana, Illinois, United States Recruiting -
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States Recruiting -
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States Recruiting -
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States Recruiting -
Iowa Methodist Medical Center
Des Moines, Iowa, United States Recruiting -
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States Recruiting -
Broadlawns Medical Center
Des Moines, Iowa, United States Recruiting -
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States Recruiting -
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States Recruiting -
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States Recruiting -
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States Recruiting -
UofL Health Medical Center Northeast
Louisville, Kentucky, United States Recruiting -
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States Recruiting -
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, United States Recruiting -
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, United States Recruiting
+128 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Dan P Zandberg — ECOG-ACRIN Cancer Research Group
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Autologous tumor membrane vesicle (TMV) vaccine alone or with pembrolizumab for recurrent or metastatic head and neck squamous cell carcinoma
This trial tests whether a vaccine made from a patient's own tumor (TMV), given alone or with pembrolizumab, can help people with recurrent or metastatic head and neck squamous cell carcinoma who had tumor tissue banked at surgery.
-
Combining lovastatin and pembrolizumab for advanced head and neck cancer treatment
This study is testing if combining a cholesterol-lowering drug called lovastatin with an immunotherapy drug called pembrolizumab can help people with advanced head and neck cancer feel better and live longer.
-
Combining cetuximab with pembrolizumab for advanced head and neck cancer
This study is testing if adding cetuximab to pembrolizumab can help people with advanced head and neck cancer live longer and feel better compared to just using pembrolizumab alone.
-
Camonsertib added to precise radiation therapy for recurrent head and neck cancer
This early-phase study tests whether the cancer drug camonsertib, given with targeted SBRT radiation, is safe and tolerable for people with recurrent or unresectable head and neck squamous cell carcinoma.
-
Cemiplimab with or without CDX-1140 given before surgery for stage III-IV head and neck cancer
This trial tests whether adding the immune stimulant CDX-1140 to cemiplimab before surgery helps shrink tumors in people with resectable stage III-IV head and neck squamous cell carcinoma.
-
Remote hearing tests for patients with head and neck cancer receiving chemotherapy or radiation
This study is testing if remote hearing tests can help patients with advanced head and neck cancer keep track of their hearing loss during chemotherapy or radiation, making it easier for those who live far away to participate.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.