Metastatic Head and Neck Squamous Cell CarcinomaPhase 3NCT06589804
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
A Phase 3 study testing Biospecimen Collection, Cetuximab and Computed Tomography in people with Metastatic Head and Neck Squamous Cell Carcinoma and Metastatic Hypopharyngeal Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 201 sites in United States.
Trial summary
This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma, Metastatic Laryngeal Squamous Cell Carcinoma
- What is being tested?
- Biospecimen Collection, Cetuximab and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 201 sitesUnited States
- Study dates
- 27 Mar 2025to 25 Dec 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis head and neck squamous cell carcinomas (HNSCC).
- Previously untreated for recurrent and/or metastatic disease incurable by local therapies.
- Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx.
- Note: Other primary tumor sites of HNSCC, including nasopharynx primary tumor are not eligible. Unknown primary tumors may be eligible and can be enrolled at the discretion of the treatment team with approval by the study chair.
- Measurable disease.
- Must have platinum-refractory disease defined as disease progression during or ≤ 29 weeks after completion of definitive therapy (chemoradiation therapy) or adjuvant (post-operative) therapy.
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- Patient must have a combined positive score PD-L1 positive (CPS >/= 1) tumor.
- Any radiation therapy must be completed >= 10 days prior to registration.
- Patients should not have received any prior treatment in the recurrent or metastatic setting.
- Prior therapy with neoadjuvant or induction anti PD-1/PD-L1 monoclonal antibody or cetuximab in the curative setting is allowed if last treatment dose was >= 26 weeks prior to registration without evidence of disease progression during that treatment period.
- Patient has not received a live vaccine within 30 days prior to registration.
- Patient does not have a history of any contraindication or has a severe hypersensitivity to any component of pembrolizumab or cetuximab (≥ grade 3).
- Patient has not received chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration.
- Patient with oropharyngeal cancer only must have negative results from testing of human papillomavirus (HPV) status defined as p16 immunohistochemistry (IHC) and/or HPV in situ hybridization (ISH).
- Note: A Clinical Laboratory Improvement Act (CLIA) certified circulating tumor HPV deoxyribonucleic acid (ctHPVDNA) assay can be used if tissue sample is not available.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Absolute neutrophil count (ANC) ≥ 1,500/mm^3.
- Platelet count ≥ 100,000/mm^3.
- Hemoglobin (Hgb) ≥ 9 g/dL (if < 9 g/dL, then transfusions are acceptable to increase hemoglobin above 9 g/dL).
- Creatinine ≤ 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault formula for participant with creatinine levels > 1.5 x institutional ULN.
- Total bilirubin ≤ 1.5 x ULN OR direct bilirubin < ULN for participant with total bilirubin > 1.5 x institutional ULN.
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) ≤ 3.0 x ULN unless liver metastases are present in which case < 5.0 x ULN.
- Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.
- Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.
- For treated/stable brain metastases: Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
- Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- 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. To be eligible for this trial, patients should be class 2B or better.
- Patients does not have a history of active myocarditis.
- Patients does not have a history of any form of pneumonitis or diffuse idiopathic or immune mediated interstitial pulmonary disease.
- Patient does not have a history of solid organ transplantation.
Who cannot join
None listed.
Trial locations and contacts
201 sites in 1 country. Contact the study team or a site near you to ask about taking part.
201 sites in 1 country
United States201 sites, 193 recruiting
- Recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Christopher M. Reynolds
- Recruiting
Mary Greeley Medical Center
Ames, Iowa, 50010
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
McFarland Clinic - Ames
Ames, Iowa, 50010
Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com
Joseph J. Merchant
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
Site Public Contact, 305-674-2625, yenrique@msmc.com
Mike Cusnir
- Recruiting
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Site Public Contact, 800-888-8823
Ranee Mehra
- Recruiting
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Site Public Contact, 847-842-4847
Peter J. Polewski
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Site Public Contact, 212-639-7592
Alan L. Ho
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Christopher M. Reynolds
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Christopher M. Reynolds
- Suspended
McFarland Clinic - Boone
Boone, Iowa, 50036
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Site Public Contact, 617-638-8265
Peter C. Everett
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Site Public Contact, 414-302-2304, ncorp@aurora.org
Peter J. Polewski
- Recruiting
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Carlisle Regional Cancer Center
Carlisle, Pennsylvania, 17015
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Dan P. Zandberg
- Recruiting
Mercy Hospital
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-365-4673
Deborah W. Wilbur
- Recruiting
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-363-2690
Deborah W. Wilbur
- Recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu
Siddharth Sheth
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu
John M. Kaczmar
- Recruiting
Vandalia Health/CAMC Institute for Academic Medicine
Charleston, West Virginia, 25304
Site Public Contact, 304-388-9944, CAMCClinicalTrials@vandaliahealth.org
Kok Hoe Chan
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Active, not recruiting
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey, 08002
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Ari J. Rosenberg
- Recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Site Public Contact, 773-296-5360
Peter J. Polewski
- Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Christine Auberle
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
Site Public Contact, 719-365-2406
Steven R. Schuster
- Recruiting
Memorial Hospital North
Colorado Springs, Colorado, 80920
Site Public Contact, 719-364-6700
Steven R. Schuster
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Site Public Contact, 212-639-7592
Alan L. Ho
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Christine Auberle
- Recruiting
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307
Site Public Contact, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Ari J. Rosenberg
- Recruiting
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Site Public Contact, 630-929-6129, advocateresearch@advocate.com
Peter J. Polewski
- Recruiting
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
Site Public Contact, 414-302-2304, ncorp@aurora.org
Peter J. Polewski
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
Miami Valley Hospital
Dayton, Ohio, 45409
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Miami Valley Hospital North
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com
Peter J. Polewski
- Recruiting
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Christopher M. Reynolds
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Advocate Sherman Hospital
Elgin, Illinois, 60123
Site Public Contact, 847-429-2907
Peter J. Polewski
- Recruiting
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu
Dan P. Zandberg
- Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Christopher M. Reynolds
- Suspended
Genesee Hematology Oncology PC
Flint, Michigan, 48503
- Recruiting
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Christopher M. Reynolds
- Recruiting
Hurley Medical Center
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Christopher M. Reynolds
- Recruiting
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Site Public Contact, 970-297-6150
Steven R. Schuster
- Recruiting
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Steven R. Schuster
- Recruiting
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Site Public Contact, 414-302-2304, ncorp@aurora.org
Peter J. Polewski
- Active, not recruiting
Glens Falls Hospital
Glens Falls, New York, 12801
- Recruiting
Lutheran Hospital - Cancer Centers of Colorado
Golden, Colorado, 80401
Site Public Contact, peaksresearch@imail.org
Karng S. Log
- Recruiting
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Site Public Contact, 414-302-2304, ncorp@aurora.org
Peter J. Polewski
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
UCHealth Greeley Hospital
Greeley, Colorado, 80631
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Steven R. Schuster
- Recruiting
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Site Public Contact, 414-302-2304, ncorp@aurora.org
Peter J. Polewski
- Recruiting
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
Site Public Contact, 724-838-1900
Dan P. Zandberg
- Recruiting
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
Site Public Contact, 937-569-7515
Tarek M. Sabagh
- Recruiting
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109
Site Public Contact, 717-724-6765, klitchfield@PINNACLEHEALTH.org
Dan P. Zandberg
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Site Public Contact, 212-639-7592
Alan L. Ho
- Recruiting
HaysMed
Hays, Kansas, 67601
Site Public Contact, 785-623-5774
Prakash C. Neupane
- Recruiting
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Site Public Contact, 708-799-9995
Peter J. Polewski
- Recruiting
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791
Site Public Contact, 828-696-4716, pardeecancerresearch@unchealth.unc.edu
John K. Hill
- Recruiting
IRMC Cancer Center
Indiana, Pennsylvania, 15701
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Dan P. Zandberg
- Suspended
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
- Recruiting
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, 15901
Site Public Contact, 814-534-4724
Dan P. Zandberg
- Recruiting
Logan Health Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Prakash C. Neupane
- Recruiting
University Health Truman Medical Center
Kansas City, Missouri, 64108
Site Public Contact, 816-404-4375
Prakash C. Neupane
- Recruiting
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, 64116
Site Public Contact, 913-588-3671
Prakash C. Neupane
- Recruiting
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Prakash C. Neupane
- Recruiting
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Site Public Contact, 414-302-2304, ncorp@aurora.org
Peter J. Polewski
- Recruiting
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org
Michael O. Ojelabi
- Recruiting
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org
Christopher M. Reynolds
- Recruiting
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
Site Public Contact, 785-505-2800, Stephanie.Norris@LMH.ORG
Prakash C. Neupane
- Recruiting
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505
Site Public Contact, 877-231-4440
Minh Phan
- Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu
Joerg Rathmann
- Recruiting
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Prakash C. Neupane
- Recruiting
Liberty Hospital
Liberty, Missouri, 64068
Site Public Contact, 913-588-1569
Prakash C. Neupane
- Recruiting
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com
Peter J. Polewski
- Recruiting
Condell Memorial Hospital
Libertyville, Illinois, 60048
Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com
Peter J. Polewski
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Site Public Contact, 501-686-8274
Omar T. Atiq
- Recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Medical Center of the Rockies
Loveland, Colorado, 80538
Site Public Contact, 970-203-7083
Steven R. Schuster
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
Site Public Contact, 414-302-2304, ncorp@aurora.org
Peter J. Polewski
- Recruiting
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Terminated
Fremont - Rideout Cancer Center
Marysville, California, 95901
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- Recruiting
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Dan P. Zandberg
- Recruiting
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Site Public Contact, 305-674-2625, Yvonne.Enriquez@msmc.com
Mike Cusnir
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Site Public Contact, 212-639-7592
Alan L. Ho
- Recruiting
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
Site Public Contact, 414-302-2304, ncorp@aurora.org
Peter J. Polewski
- Recruiting
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Site Public Contact, 414-302-2304, ncorp@aurora.org
Peter J. Polewski
- Recruiting
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Site Public Contact, 414-302-2304, ncorp@aurora.org
Peter J. Polewski
- Recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Community Medical Center
Missoula, Montana, 59804
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Avera Cancer Institute - Mitchell
Mitchell, South Dakota, 57301
Site Public Contact, 605-322-3096, OncRegulatory@avera.org
Benjamin M. Solomon
- Recruiting
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146
Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu
Dan P. Zandberg
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Site Public Contact, 212-639-7592
Alan L. Ho
- Recruiting
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
Site Public Contact, research.institute@phci.org
Timothy R. Wassenaar
- Recruiting
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Christopher M. Reynolds
- Recruiting
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Ari J. Rosenberg
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Site Public Contact, 212-639-7592
Alan L. Ho
- Recruiting
Carle BroMenn Medical Center
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
Carle Cancer Institute Normal
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
Site Public Contact, 800-323-8622
Peter J. Polewski
- Recruiting
Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois, 60453
Site Public Contact, ncorp@aah.org
Peter J. Polewski
- Recruiting
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
Site Public Contact, 262-928-7878
Timothy R. Wassenaar
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Minh Phan
- Recruiting
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, 66061
Site Public Contact, 913-588-1569, OlatheCCResearch@kumc.edu
Prakash C. Neupane
- Recruiting
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Christopher M. Reynolds
- Recruiting
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Recruiting
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Ari J. Rosenberg
- Recruiting
Lake Regional Hospital
Osage Beach, Missouri, 65065
Site Public Contact, 573-302-2768, clinicaltrials@lakeregional.com
Jay W. Carlson
- Recruiting
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
Site Public Contact, 414-302-2304, ncorp@aurora.org
Peter J. Polewski
- Recruiting
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Prakash C. Neupane
- Recruiting
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Prakash C. Neupane
- Recruiting
VA Palo Alto Health Care System
Palo Alto, California, 94304
Site Public Contact, 800-455-0057
Harlan A. Pinto
- Recruiting
Advocate High Tech Medical Park
Palos Heights, Illinois, 60463
Site Public Contact, ncorp@aah.org
Peter J. Polewski
- Recruiting
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Site Public Contact, 847-384-3621
Peter J. Polewski
- Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Active, not recruiting
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, 19114
- Recruiting
Avera Cancer Institute at Pierre
Pierre, South Dakota, 57501
Site Public Contact, 605-322-3095, OncRegulatory@avera.org
Benjamin M. Solomon
- Recruiting
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374
Site Public Contact, 910-715-3500, jcwilliams@firsthealth.org
Charles S. Kuzma
- Recruiting
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, 15215
Site Public Contact, 412-784-4900
Dan P. Zandberg
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Site Public Contact, 412-647-8073
Dan P. Zandberg
- Recruiting
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237
Site Public Contact, 412-367-6454
Dan P. Zandberg
- Recruiting
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243
Site Public Contact, 412-502-3920
Dan P. Zandberg
- Recruiting
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Recruiting
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406
Site Public Contact, 414-302-2304, ncorp@aurora.org
Peter J. Polewski
- Recruiting
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
Site Public Contact, ctoclinops@vcu.edu
Erin R. Alesi
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Site Public Contact, 804-628-6430, CTOclinops@vcu.edu
Erin R. Alesi
- Recruiting
UW Health Carbone Cancer Center Rockford
Rockford, Illinois, 61114
Site Public Contact, 779-696-9378, lkline@uwhealth.org
Fahrettin Covut
- Recruiting
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819
Site Public Contact, 800-639-6918, cancer.research.nurse@hitchcock.org
Joerg Rathmann
- Recruiting
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Regions Hospital
Saint Paul, Minnesota, 55101
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
United Hospital
Saint Paul, Minnesota, 55102
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Salina Regional Health Center
Salina, Kansas, 67401
Site Public Contact, 785-452-7038, mleepers@srhc.com
Prakash C. Neupane
- Recruiting
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, 16346
Site Public Contact, 814-676-7900
Dan P. Zandberg
- Active, not recruiting
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, 08080
- Recruiting
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081
Site Public Contact, 414-302-2304, ncorp@aurora.org
Peter J. Polewski
- Recruiting
Memorial Hospital East
Shiloh, Illinois, 62269
Site Public Contact, 314-747-9912, dschwab@wustl.edu
Christine Auberle
- Recruiting
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Site Public Contact, 605-312-3320, OncologyClinicTrialsSF@sanfordhealth.org
Daniel Almquist
- Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Site Public Contact, 605-322-3095, OncRegulatory@avera.org
Benjamin M. Solomon
- Recruiting
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org
Daniel Almquist
- Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Site Public Contact, 217-545-7929
Bryan A. Faller
- Recruiting
Springfield Clinic
Springfield, Illinois, 62702
Site Public Contact, 800-444-7541
Bryan A. Faller
- Recruiting
Springfield Memorial Hospital
Springfield, Illinois, 62781
Site Public Contact, 217-528-7541, pallante.beth@mhsil.com
Bryan A. Faller
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Christine Auberle
- Recruiting
Mercy Hospital South
St Louis, Missouri, 63128
Site Public Contact, 314-525-6042, Danielle.Werle@mercy.net
Jay W. Carlson
- Recruiting
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Christine Auberle
- Recruiting
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Christine Auberle
- Recruiting
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Aurora Medical Center in Summit
Summit, Wisconsin, 53066
Site Public Contact, 414-302-2304, ncorp@aurora.org
Peter J. Polewski
- Recruiting
ProMedica Flower Hospital
Sylvania, Ohio, 43560
Site Public Contact, 419-824-1842, PCIOncResearch@promedica.org
Chang Xia
- Recruiting
State University of New York Upstate Medical University
Syracuse, New York, 13210
Site Public Contact, 315-464-5476
Komal Akhtar
- Recruiting
SUNY Upstate Medical Center-Community Campus
Syracuse, New York, 13215
Site Public Contact, 315-464-5476
Komal Akhtar
- Recruiting
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606
Site Public Contact, 785-295-8000
Prakash C. Neupane
- Recruiting
Upper Valley Medical Center
Troy, Ohio, 45373
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241
Site Public Contact, 414-302-2304, ncorp@aurora.org
Peter J. Polewski
- Recruiting
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
Site Public Contact, 212-639-7592
Alan L. Ho
- Recruiting
UPMC Cancer Center-Uniontown
Uniontown, Pennsylvania, 15401
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Dan P. Zandberg
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- Recruiting
Upstate Cancer Center at Verona
Verona, New York, 13478
Site Public Contact, 315-464-8230, McDowelE@upstate.edu
Komal Akhtar
- Recruiting
UPMC Cancer Center-Washington
Washington, Pennsylvania, 15301
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Dan P. Zandberg
- Recruiting
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
Site Public Contact, 262-928-7632
Timothy R. Wassenaar
- Recruiting
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
Site Public Contact, 262-928-5539, Chanda.miller@phci.org
Timothy R. Wassenaar
- Recruiting
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226
Site Public Contact, 414-302-2304, ncorp@aurora.org
Peter J. Polewski
- Recruiting
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227
Site Public Contact, 414-302-2304, ncorp@aurora.org
Peter J. Polewski
- Recruiting
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Prakash C. Neupane
- Recruiting
Avera Cancer Institute at Yankton
Yankton, South Dakota, 57078
Site Public Contact, 605-655-1800, OncRegulatory@avera.org
Benjamin M. Solomon
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
About this study
Official title: Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease
This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic). Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent and/or metastatic HNSCC than pembrolizumab alone.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess whether the combination of cetuximab and pembrolizumab (arm 2) compared to pembrolizumab alone (arm 1) results in improved overall survival (OS) in subjects with platinum refractory HNSCC.
SECONDARY OBJECTIVES:
- To compare pembrolizumab + cetuximab (arm 2) versus (vs.) pembrolizumab alone (arm 1) with respect to objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
II. To compare pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1) with respect to progression free survival (PFS) per RECIST 1.1.
III. To evaluate pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1) with respect to duration of response (DOR) per RECIST 1.1.
IV. To assess the safety and tolerability of pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1).
- To assess the patient-reported toxicity using Patient Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) of pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1).
EXPLORATORY OBJECTIVES:
- To identify specific mutational changes that may be indicative of clinical response to pembrolizumab + cetuximab and pembrolizumab alone.
II. To evaluate circulating tumor-derived deoxyribonucleic acid (ctDNA) kinetics over the course of treatment in response to pembrolizumab + cetuximab and pembrolizumab alone.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT), positron emission tomography (PET)/CT or magnetic resonance imaging (MRI) throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment.
ARM 2: Patients receive cetuximab IV over 120 minutes on day -14 prior to cycle 1 and then on days 1, 15 and 29 of each cycle and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT or MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment.
After completion of study treatment, patients are followed up within 4 weeks and then every 3 and/or 6 months for up to 5 years.
- Conditions
- Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma, Metastatic Laryngeal Squamous Cell Carcinoma, Metastatic Oral Cavity Squamous Cell Carcinoma, Metastatic Oropharyngeal Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma
- Being tested
- Biospecimen Collection, Cetuximab, Computed Tomography, Magnetic Resonance Imaging, Pembrolizumab
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Mouth Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
CetuximabBiological
Also called C 225, C-225, C225, Cetuxa
Given IV
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT or PET/CT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
PembrolizumabBiological
Also called BCD-201, GME 751, GME751, Keytruda
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (pembrolizumab) | Active comparator | Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT or MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Biological: Pembrolizumab; Procedure: Positron Emission Tomography |
| Arm 2 (cetuximab, pembrolizumab) | Experimental | Patients receive cetuximab IV over 120 minutes on day -14 prior to cycle 1 and then on days 1, 15 and 29 of each cycle and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT or MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment. Receives: Procedure: Biospecimen Collection; Biological: Cetuximab; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Biological: Pembrolizumab; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Will be estimated using the Kaplan-Meier method. Will be based on the stratified log-rank test that will compare the distributions across the treatment arms. Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be assessed as well, where the multivariable Cox model will also adjust for other key baseline factors of interest. Hazard ratios and 95% confidence intervals, along with likelihood ratio p-values will be reported from these Cox models. Forest plots will be used to illustrate the comparisons between the arms within subgroups defined by stratification factors and key baseline characteristics.
Measured: Time from randomization to death from any cause, assessed up to 5 years
Secondary outcomes (5)
Confirmed response rate
Will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria if patients have a partial or complete response for 2 consecutive evaluations at least 4 weeks apart, using local review only. The proportion of patients with a confirmed response will be calculated and compared between the 2 arms using a Chi-square or Fisher's Exact test.
Measured: Up to 5 years
Duration of response
Will be defined for all evaluable patients who have achieved an objective response. Will be assessed per RECIST 1.1 criteria. Will be estimated using the Kaplan-Meier method.
Measured: From the date at which the patient's earliest best objective status is first noted to be either a complete response or partial response to the earliest date progression is documented, assessed up to 5 years
Progression free survival
Disease progression will be assessed per RECIST 1.1 criteria. Will be compared between the 2 arms using the Kaplan-Meier method, where the log-rank test will be used to calculate the p-value.
Measured: Time from randomization to the first of either disease progression or death from any cause, assessed up to 5 years
Incidence of adverse events
Will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The frequency and percentage of grade 3+ adverse events will be compared between the 2 treatment arms. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test.
Measured: Up to 5 years
Patient-reported toxicity
Will be assessed using Patient-Reported Outcomes version of the CTCAE. The frequency and proportion of patients with a maximum post-baseline score greater than 0 will be compared across arms using a Chi-square or Fisher's exact test with a nominal significance level of alpha = 0.10. Similarly, the frequency and proportion of patients with a maximum post-baseline score greater than or equal to 3 will be compared across arms using a Chi-square or Fisher's exact test with a nominal significance level of alpha = 0.10. Patients' maximum baseline-adjusted scores will be calculated using the method described by Dueck et al.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Mar 2025
- Primary completion25 Dec 2032 (estimated)
- Study completion25 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Siddharth Sheth, Principal investigator, Alliance for Clinical Trials in Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589804
- Sponsor's protocol ID
- NCI-2024-07339
- Other IDs
- NCI-2024-07339, A092205, A092205, U10CA180821
- Status last verified
- Oct 2026
- First submitted
- 6 Sep 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.