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Afprøvning af tilsætning af anti-cancer-lægemiddel, Cetuximab, til standardbehandling (Pembrolizumab) for tilbagevenden eller spredning af hoved- og nakkekræft efter tidligere behandling

31. oktober 2026 opdateret af: National Cancer Institute (NCI)

Randomiseret fase III-forsøg med Pembrolizumab vs. Pembrolizumab/Cetuximab ved tilbagevendende eller metastatisk hoved- og halspladecellecarcinom med platin refraktær sygdom

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.

Studieoversigt

Status

Rekruttering

Intervention / Behandling

Detaljeret beskrivelse

PRIMARY OBJECTIVE:

I. 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:

I. 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).

V. 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:

I. 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

158

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Rekruttering
        • University of Arkansas for Medical Sciences
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 501-686-8274
        • Ledende efterforsker:
          • Omar T. Atiq
    • California
      • Marysville, California, Forenede Stater, 95901
        • Afsluttet
        • Fremont - Rideout Cancer Center
      • Palo Alto, California, Forenede Stater, 94304
        • Rekruttering
        • VA Palo Alto Health Care System
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-455-0057
        • Ledende efterforsker:
          • Harlan A. Pinto
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80909
        • Rekruttering
        • UCHealth Memorial Hospital Central
        • Ledende efterforsker:
          • Steven R. Schuster
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 719-365-2406
      • Colorado Springs, Colorado, Forenede Stater, 80920
        • Rekruttering
        • Memorial Hospital North
        • Ledende efterforsker:
          • Steven R. Schuster
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 719-364-6700
      • Fort Collins, Colorado, Forenede Stater, 80524
        • Rekruttering
        • Poudre Valley Hospital
        • Ledende efterforsker:
          • Steven R. Schuster
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 970-297-6150
      • Fort Collins, Colorado, Forenede Stater, 80528
        • Rekruttering
        • Cancer Care and Hematology-Fort Collins
        • Ledende efterforsker:
          • Steven R. Schuster
        • Kontakt:
      • Golden, Colorado, Forenede Stater, 80401
        • Rekruttering
        • Lutheran Hospital - Cancer Centers of Colorado
        • Ledende efterforsker:
          • Karng S. Log
        • Kontakt:
      • Greeley, Colorado, Forenede Stater, 80631
        • Rekruttering
        • UCHealth Greeley Hospital
        • Ledende efterforsker:
          • Steven R. Schuster
        • Kontakt:
      • Loveland, Colorado, Forenede Stater, 80538
        • Rekruttering
        • Medical Center of the Rockies
        • Ledende efterforsker:
          • Steven R. Schuster
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 970-203-7083
    • Florida
      • Aventura, Florida, Forenede Stater, 33180
        • Rekruttering
        • Mount Sinai Comprehensive Cancer Center at Aventura
        • Kontakt:
        • Ledende efterforsker:
          • Mike Cusnir
      • Miami Beach, Florida, Forenede Stater, 33140
        • Rekruttering
        • Mount Sinai Medical Center
        • Ledende efterforsker:
          • Mike Cusnir
        • Kontakt:
    • Idaho
      • Boise, Idaho, Forenede Stater, 83706
        • Rekruttering
        • Saint Alphonsus Cancer Care Center-Boise
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Caldwell, Idaho, Forenede Stater, 83605
        • Rekruttering
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Coeur d'Alene, Idaho, Forenede Stater, 83814
        • Rekruttering
        • Kootenai Health - Coeur d'Alene
        • Ledende efterforsker:
          • John M. Schallenkamp
        • Kontakt:
      • Nampa, Idaho, Forenede Stater, 83687
        • Rekruttering
        • Saint Alphonsus Cancer Care Center-Nampa
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Post Falls, Idaho, Forenede Stater, 83854
        • Rekruttering
        • Kootenai Clinic Cancer Services - Post Falls
        • Ledende efterforsker:
          • John M. Schallenkamp
        • Kontakt:
      • Sandpoint, Idaho, Forenede Stater, 83864
        • Rekruttering
        • Kootenai Clinic Cancer Services - Sandpoint
        • Ledende efterforsker:
          • John M. Schallenkamp
        • Kontakt:
    • Illinois
      • Barrington, Illinois, Forenede Stater, 60010
        • Rekruttering
        • Advocate Good Shepherd Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 847-842-4847
        • Ledende efterforsker:
          • Peter J. Polewski
      • Chicago, Illinois, Forenede Stater, 60637
        • Rekruttering
        • University of Chicago Comprehensive Cancer Center
        • Kontakt:
        • Ledende efterforsker:
          • Ari J. Rosenberg
      • Chicago, Illinois, Forenede Stater, 60657
        • Rekruttering
        • Advocate Illinois Masonic Medical Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 773-296-5360
        • Ledende efterforsker:
          • Peter J. Polewski
      • Crystal Lake, Illinois, Forenede Stater, 60014
        • Rekruttering
        • AMG Crystal Lake - Oncology
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Danville, Illinois, Forenede Stater, 61832
        • Rekruttering
        • Carle at The Riverfront
        • Ledende efterforsker:
          • Suparna Mantha
        • Kontakt:
      • Decatur, Illinois, Forenede Stater, 62526
        • Rekruttering
        • Cancer Care Specialists of Illinois - Decatur
        • Ledende efterforsker:
          • Bryan A. Faller
        • Kontakt:
      • Decatur, Illinois, Forenede Stater, 62526
        • Rekruttering
        • Decatur Memorial Hospital
        • Ledende efterforsker:
          • Bryan A. Faller
        • Kontakt:
      • Downers Grove, Illinois, Forenede Stater, 60515
        • Rekruttering
        • Advocate Good Samaritan Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Effingham, Illinois, Forenede Stater, 62401
        • Rekruttering
        • Carle Physician Group-Effingham
        • Ledende efterforsker:
          • Suparna Mantha
        • Kontakt:
      • Effingham, Illinois, Forenede Stater, 62401
        • Rekruttering
        • Crossroads Cancer Center
        • Ledende efterforsker:
          • Bryan A. Faller
        • Kontakt:
      • Elgin, Illinois, Forenede Stater, 60123
        • Rekruttering
        • Advocate Sherman Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 847-429-2907
        • Ledende efterforsker:
          • Peter J. Polewski
      • Hazel Crest, Illinois, Forenede Stater, 60429
        • Rekruttering
        • Advocate South Suburban Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 708-799-9995
        • Ledende efterforsker:
          • Peter J. Polewski
      • Libertyville, Illinois, Forenede Stater, 60048
        • Rekruttering
        • AMG Libertyville - Oncology
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Libertyville, Illinois, Forenede Stater, 60048
        • Rekruttering
        • Condell Memorial Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Macomb, Illinois, Forenede Stater, 61455
        • Rekruttering
        • Illinois CancerCare-Macomb
        • Kontakt:
        • Ledende efterforsker:
          • Bryan A. Faller
      • Mattoon, Illinois, Forenede Stater, 61938
        • Rekruttering
        • Carle Physician Group-Mattoon/Charleston
        • Ledende efterforsker:
          • Suparna Mantha
        • Kontakt:
      • New Lenox, Illinois, Forenede Stater, 60451
        • Rekruttering
        • UC Comprehensive Cancer Center at Silver Cross
        • Kontakt:
        • Ledende efterforsker:
          • Ari J. Rosenberg
      • Normal, Illinois, Forenede Stater, 61761
        • Rekruttering
        • Carle BroMenn Medical Center
        • Ledende efterforsker:
          • Suparna Mantha
        • Kontakt:
      • Normal, Illinois, Forenede Stater, 61761
        • Rekruttering
        • Carle Cancer Institute Normal
        • Ledende efterforsker:
          • Suparna Mantha
        • Kontakt:
      • O'Fallon, Illinois, Forenede Stater, 62269
        • Rekruttering
        • Cancer Care Center of O'Fallon
        • Ledende efterforsker:
          • Bryan A. Faller
        • Kontakt:
      • Oak Lawn, Illinois, Forenede Stater, 60453-2699
        • Rekruttering
        • Advocate Christ Medical Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-323-8622
        • Ledende efterforsker:
          • Peter J. Polewski
      • Oak Lawn, Illinois, Forenede Stater, 60453
        • Rekruttering
        • Advocate Outpatient Center - Oak Lawn
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Orland Park, Illinois, Forenede Stater, 60462
        • Rekruttering
        • University of Chicago Medicine-Orland Park
        • Kontakt:
        • Ledende efterforsker:
          • Ari J. Rosenberg
      • Palos Heights, Illinois, Forenede Stater, 60463
        • Rekruttering
        • Advocate High Tech Medical Park
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Park Ridge, Illinois, Forenede Stater, 60068
        • Rekruttering
        • Advocate Lutheran General Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 847-384-3621
        • Ledende efterforsker:
          • Peter J. Polewski
      • Peoria, Illinois, Forenede Stater, 61615
        • Rekruttering
        • Illinois CancerCare-Peoria
        • Kontakt:
        • Ledende efterforsker:
          • Bryan A. Faller
      • Rockford, Illinois, Forenede Stater, 61114
        • Rekruttering
        • UW Health Carbone Cancer Center Rockford
        • Kontakt:
        • Ledende efterforsker:
          • Fahrettin Covut
      • Shiloh, Illinois, Forenede Stater, 62269
        • Rekruttering
        • Memorial Hospital East
        • Kontakt:
        • Ledende efterforsker:
          • Christine Auberle
      • Springfield, Illinois, Forenede Stater, 62702
        • Rekruttering
        • Southern Illinois University School of Medicine
        • Ledende efterforsker:
          • Bryan A. Faller
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 217-545-7929
      • Springfield, Illinois, Forenede Stater, 62702
        • Rekruttering
        • Springfield Clinic
        • Ledende efterforsker:
          • Bryan A. Faller
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-444-7541
      • Springfield, Illinois, Forenede Stater, 62781
        • Rekruttering
        • Springfield Memorial Hospital
        • Ledende efterforsker:
          • Bryan A. Faller
        • Kontakt:
      • Urbana, Illinois, Forenede Stater, 61801
        • Rekruttering
        • Carle Cancer Center
        • Ledende efterforsker:
          • Suparna Mantha
        • Kontakt:
    • Indiana
      • Crown Point, Indiana, Forenede Stater, 46307
        • Rekruttering
        • UChicago Medicine Northwest Indiana
        • Ledende efterforsker:
          • Ari J. Rosenberg
        • Kontakt:
    • Iowa
      • Ames, Iowa, Forenede Stater, 50010
        • Rekruttering
        • Mary Greeley Medical Center
        • Ledende efterforsker:
          • Joseph J. Merchant
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 515-956-4132
      • Ames, Iowa, Forenede Stater, 50010
        • Rekruttering
        • McFarland Clinic - Ames
        • Ledende efterforsker:
          • Joseph J. Merchant
        • Kontakt:
      • Boone, Iowa, Forenede Stater, 50036
        • Suspenderet
        • McFarland Clinic - Boone
      • Cedar Rapids, Iowa, Forenede Stater, 52403
        • Rekruttering
        • Mercy Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 319-365-4673
        • Ledende efterforsker:
          • Deborah W. Wilbur
      • Cedar Rapids, Iowa, Forenede Stater, 52403
        • Rekruttering
        • Oncology Associates at Mercy Medical Center
        • Ledende efterforsker:
          • Deborah W. Wilbur
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 319-363-2690
      • Fort Dodge, Iowa, Forenede Stater, 50501
        • Rekruttering
        • McFarland Clinic - Trinity Cancer Center
        • Ledende efterforsker:
          • Joseph J. Merchant
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 515-956-4132
      • Jefferson, Iowa, Forenede Stater, 50129
        • Suspenderet
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, Forenede Stater, 50158
        • Rekruttering
        • McFarland Clinic - Marshalltown
        • Ledende efterforsker:
          • Joseph J. Merchant
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 515-956-4132
    • Kansas
      • Hays, Kansas, Forenede Stater, 67601
        • Rekruttering
        • HaysMed
        • Ledende efterforsker:
          • Prakash C. Neupane
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 785-623-5774
      • Kansas City, Kansas, Forenede Stater, 66160
        • Rekruttering
        • University of Kansas Cancer Center
        • Ledende efterforsker:
          • Prakash C. Neupane
        • Kontakt:
      • Lawrence, Kansas, Forenede Stater, 66044
        • Rekruttering
        • Lawrence Memorial Hospital
        • Ledende efterforsker:
          • Prakash C. Neupane
        • Kontakt:
      • Olathe, Kansas, Forenede Stater, 66061
        • Rekruttering
        • The University of Kansas Cancer Center - Olathe
        • Ledende efterforsker:
          • Prakash C. Neupane
        • Kontakt:
      • Overland Park, Kansas, Forenede Stater, 66211
        • Rekruttering
        • University of Kansas Hospital-Indian Creek Campus
        • Ledende efterforsker:
          • Prakash C. Neupane
        • Kontakt:
      • Overland Park, Kansas, Forenede Stater, 66210
        • Rekruttering
        • University of Kansas Cancer Center-Overland Park
        • Ledende efterforsker:
          • Prakash C. Neupane
        • Kontakt:
      • Salina, Kansas, Forenede Stater, 67401
        • Rekruttering
        • Salina Regional Health Center
        • Ledende efterforsker:
          • Prakash C. Neupane
        • Kontakt:
      • Topeka, Kansas, Forenede Stater, 66606
        • Rekruttering
        • University of Kansas Health System Saint Francis Campus
        • Ledende efterforsker:
          • Prakash C. Neupane
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 785-295-8000
      • Westwood, Kansas, Forenede Stater, 66205
        • Rekruttering
        • University of Kansas Hospital-Westwood Cancer Center
        • Ledende efterforsker:
          • Prakash C. Neupane
        • Kontakt:
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Rekruttering
        • University of Maryland/Greenebaum Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 800-888-8823
        • Ledende efterforsker:
          • Ranee Mehra
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Rekruttering
        • Boston Medical Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 617-638-8265
        • Ledende efterforsker:
          • Peter C. Everett
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • Rekruttering
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Brighton, Michigan, Forenede Stater, 48114
        • Rekruttering
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Canton, Michigan, Forenede Stater, 48188
        • Rekruttering
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Chelsea, Michigan, Forenede Stater, 48118
        • Rekruttering
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Flint, Michigan, Forenede Stater, 48503
        • Rekruttering
        • Genesys Hurley Cancer Institute
        • Ledende efterforsker:
          • Christopher M. Reynolds
        • Kontakt:
      • Flint, Michigan, Forenede Stater, 48503
        • Rekruttering
        • Hurley Medical Center
        • Ledende efterforsker:
          • Christopher M. Reynolds
        • Kontakt:
      • Flint, Michigan, Forenede Stater, 48503
        • Suspenderet
        • Genesee Hematology Oncology PC
      • Flint, Michigan, Forenede Stater, 48503
        • Rekruttering
        • Cancer Hematology Centers - Flint
        • Ledende efterforsker:
          • Christopher M. Reynolds
        • Kontakt:
      • Lansing, Michigan, Forenede Stater, 48912
        • Rekruttering
        • University of Michigan Health - Sparrow Lansing
        • Ledende efterforsker:
          • Christopher M. Reynolds
        • Kontakt:
      • Livonia, Michigan, Forenede Stater, 48154
        • Rekruttering
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Pontiac, Michigan, Forenede Stater, 48341
        • Rekruttering
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Ypsilanti, Michigan, Forenede Stater, 48197
        • Rekruttering
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
    • Minnesota
      • Bemidji, Minnesota, Forenede Stater, 56601
      • Burnsville, Minnesota, Forenede Stater, 55337
        • Rekruttering
        • Minnesota Oncology - Burnsville
        • Kontakt:
        • Ledende efterforsker:
          • Yan Ji
      • Coon Rapids, Minnesota, Forenede Stater, 55433
        • Rekruttering
        • Mercy Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Yan Ji
      • Edina, Minnesota, Forenede Stater, 55435
        • Rekruttering
        • Fairview Southdale Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Yan Ji
      • Edina, Minnesota, Forenede Stater, 55435
        • Rekruttering
        • Minnesota Oncology - Edina
        • Kontakt:
        • Ledende efterforsker:
          • Yan Ji
      • Maplewood, Minnesota, Forenede Stater, 55109
        • Rekruttering
        • Saint John's Hospital - Healtheast
        • Kontakt:
        • Ledende efterforsker:
          • Yan Ji
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Rekruttering
        • Abbott-Northwestern Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Yan Ji
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • Rekruttering
        • Hennepin County Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Yan Ji
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Rekruttering
        • Park Nicollet Clinic - Saint Louis Park
        • Kontakt:
        • Ledende efterforsker:
          • Yan Ji
      • Saint Paul, Minnesota, Forenede Stater, 55101
        • Rekruttering
        • Regions Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Yan Ji
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • Rekruttering
        • United Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Yan Ji
    • Missouri
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • Rekruttering
        • Saint Francis Medical Center
        • Ledende efterforsker:
          • Bryan A. Faller
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 573-334-2230
          • E-mail: sfmc@sfmc.net
      • City of Saint Peters, Missouri, Forenede Stater, 63376
        • Rekruttering
        • Siteman Cancer Center at Saint Peters Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Christine Auberle
      • Creve Coeur, Missouri, Forenede Stater, 63141
        • Rekruttering
        • Siteman Cancer Center at West County Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Christine Auberle
      • Kansas City, Missouri, Forenede Stater, 64154
        • Rekruttering
        • University of Kansas Cancer Center - North
        • Ledende efterforsker:
          • Prakash C. Neupane
        • Kontakt:
      • Kansas City, Missouri, Forenede Stater, 64108
        • Rekruttering
        • University Health Truman Medical Center
        • Ledende efterforsker:
          • Prakash C. Neupane
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 816-404-4375
      • Kansas City, Missouri, Forenede Stater, 64116
        • Rekruttering
        • University of Kansas Cancer Center - Briarcliff
        • Ledende efterforsker:
          • Prakash C. Neupane
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 913-588-3671
      • Lee's Summit, Missouri, Forenede Stater, 64064
        • Rekruttering
        • University of Kansas Cancer Center - Lee's Summit
        • Ledende efterforsker:
          • Prakash C. Neupane
        • Kontakt:
      • Liberty, Missouri, Forenede Stater, 64068
        • Rekruttering
        • Liberty Hospital
        • Ledende efterforsker:
          • Prakash C. Neupane
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 913-588-1569
      • Osage Beach, Missouri, Forenede Stater, 65065
        • Rekruttering
        • Lake Regional Hospital
        • Ledende efterforsker:
          • Jay W. Carlson
        • Kontakt:
      • St Louis, Missouri, Forenede Stater, 63110
        • Rekruttering
        • Washington University School of Medicine
        • Kontakt:
        • Ledende efterforsker:
          • Christine Auberle
      • St Louis, Missouri, Forenede Stater, 63128
        • Rekruttering
        • Mercy Hospital South
        • Ledende efterforsker:
          • Jay W. Carlson
        • Kontakt:
      • St Louis, Missouri, Forenede Stater, 63129
        • Rekruttering
        • Siteman Cancer Center-South County
        • Kontakt:
        • Ledende efterforsker:
          • Christine Auberle
      • St Louis, Missouri, Forenede Stater, 63136
        • Rekruttering
        • Siteman Cancer Center at Christian Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Christine Auberle
    • Montana
      • Anaconda, Montana, Forenede Stater, 59711
        • Rekruttering
        • Community Hospital of Anaconda
        • Ledende efterforsker:
          • John M. Schallenkamp
        • Kontakt:
      • Billings, Montana, Forenede Stater, 59101
        • Rekruttering
        • Billings Clinic Cancer Center
        • Ledende efterforsker:
          • John M. Schallenkamp
        • Kontakt:
      • Bozeman, Montana, Forenede Stater, 59715
        • Rekruttering
        • Bozeman Health Deaconess Hospital
        • Ledende efterforsker:
          • John M. Schallenkamp
        • Kontakt:
      • Great Falls, Montana, Forenede Stater, 59405
        • Rekruttering
        • Benefis Sletten Cancer Institute
        • Ledende efterforsker:
          • John M. Schallenkamp
        • Kontakt:
      • Kalispell, Montana, Forenede Stater, 59901
        • Rekruttering
        • Logan Health Medical Center
        • Ledende efterforsker:
          • John M. Schallenkamp
        • Kontakt:
      • Missoula, Montana, Forenede Stater, 59804
        • Rekruttering
        • Community Medical Center
        • Ledende efterforsker:
          • John M. Schallenkamp
        • Kontakt:
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • Rekruttering
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Kontakt:
        • Ledende efterforsker:
          • Joerg Rathmann
    • New Jersey
      • Basking Ridge, New Jersey, Forenede Stater, 07920
        • Rekruttering
        • Memorial Sloan Kettering Basking Ridge
        • Ledende efterforsker:
          • Alan L. Ho
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
      • Cherry Hill, New Jersey, Forenede Stater, 08002
        • Aktiv, ikke rekrutterende
        • Jefferson Cherry Hill Hospital
      • Middletown, New Jersey, Forenede Stater, 07748
        • Rekruttering
        • Memorial Sloan Kettering Monmouth
        • Ledende efterforsker:
          • Alan L. Ho
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
      • Montvale, New Jersey, Forenede Stater, 07645
        • Rekruttering
        • Memorial Sloan Kettering Bergen
        • Ledende efterforsker:
          • Alan L. Ho
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
      • Sewell, New Jersey, Forenede Stater, 08080
        • Aktiv, ikke rekrutterende
        • Sidney Kimmel Cancer Center Washington Township
    • New York
      • Commack, New York, Forenede Stater, 11725
        • Rekruttering
        • Memorial Sloan Kettering Commack
        • Ledende efterforsker:
          • Alan L. Ho
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
      • Glens Falls, New York, Forenede Stater, 12801
        • Aktiv, ikke rekrutterende
        • Glens Falls Hospital
      • Harrison, New York, Forenede Stater, 10604
        • Rekruttering
        • Memorial Sloan Kettering Westchester
        • Ledende efterforsker:
          • Alan L. Ho
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
      • New York, New York, Forenede Stater, 10065
        • Rekruttering
        • Memorial Sloan Kettering Cancer Center
        • Ledende efterforsker:
          • Alan L. Ho
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
      • Syracuse, New York, Forenede Stater, 13210
        • Rekruttering
        • State University of New York Upstate Medical University
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 315-464-5476
        • Ledende efterforsker:
          • Komal Akhtar
      • Syracuse, New York, Forenede Stater, 13215
        • Rekruttering
        • SUNY Upstate Medical Center-Community Campus
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 315-464-5476
        • Ledende efterforsker:
          • Komal Akhtar
      • Uniondale, New York, Forenede Stater, 11553
        • Rekruttering
        • Memorial Sloan Kettering Nassau
        • Ledende efterforsker:
          • Alan L. Ho
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
      • Verona, New York, Forenede Stater, 13478
        • Rekruttering
        • Upstate Cancer Center at Verona
        • Kontakt:
        • Ledende efterforsker:
          • Komal Akhtar
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • Rekruttering
        • UNC Lineberger Comprehensive Cancer Center
        • Kontakt:
        • Ledende efterforsker:
          • Siddharth Sheth
      • Hendersonville, North Carolina, Forenede Stater, 28791
      • Pinehurst, North Carolina, Forenede Stater, 28374
        • Rekruttering
        • FirstHealth of the Carolinas-Moore Regional Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Charles S. Kuzma
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58501
      • Fargo, North Dakota, Forenede Stater, 58122
      • Fargo, North Dakota, Forenede Stater, 58122
    • Ohio
      • Centerville, Ohio, Forenede Stater, 45459
        • Rekruttering
        • Miami Valley Hospital South
        • Kontakt:
        • Ledende efterforsker:
          • Tarek M. Sabagh
      • Dayton, Ohio, Forenede Stater, 45409
        • Rekruttering
        • Miami Valley Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Tarek M. Sabagh
      • Dayton, Ohio, Forenede Stater, 45415
        • Rekruttering
        • Miami Valley Hospital North
        • Kontakt:
        • Ledende efterforsker:
          • Tarek M. Sabagh
      • Franklin, Ohio, Forenede Stater, 45005-1066
        • Rekruttering
        • Atrium Medical Center-Middletown Regional Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Tarek M. Sabagh
      • Greenville, Ohio, Forenede Stater, 45331
        • Rekruttering
        • Miami Valley Cancer Care and Infusion
        • Ledende efterforsker:
          • Tarek M. Sabagh
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 937-569-7515
      • Sylvania, Ohio, Forenede Stater, 43560
        • Rekruttering
        • ProMedica Flower Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Chang Xia
      • Troy, Ohio, Forenede Stater, 45373
        • Rekruttering
        • Upper Valley Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Tarek M. Sabagh
    • Oklahoma
      • Lawton, Oklahoma, Forenede Stater, 73505
        • Rekruttering
        • Cancer Centers of Southwest Oklahoma Research
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 877-231-4440
        • Ledende efterforsker:
          • Minh Phan
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Rekruttering
        • University of Oklahoma Health Sciences Center
        • Kontakt:
        • Ledende efterforsker:
          • Minh Phan
    • Oregon
      • Ontario, Oregon, Forenede Stater, 97914
        • Rekruttering
        • Saint Alphonsus Cancer Care Center-Ontario
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M. Reynolds
      • Oregon City, Oregon, Forenede Stater, 97045
        • Rekruttering
        • Providence Willamette Falls Medical Center
        • Ledende efterforsker:
          • Alison K. Conlin
        • Kontakt:
      • Portland, Oregon, Forenede Stater, 97213
        • Rekruttering
        • Providence Portland Medical Center
        • Ledende efterforsker:
          • Alison K. Conlin
        • Kontakt:
      • Portland, Oregon, Forenede Stater, 97225
        • Rekruttering
        • Providence Saint Vincent Medical Center
        • Ledende efterforsker:
          • Alison K. Conlin
        • Kontakt:
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18103
        • Rekruttering
        • Lehigh Valley Hospital-Cedar Crest
        • Ledende efterforsker:
          • Christopher M. Reynolds
        • Kontakt:
      • Bethlehem, Pennsylvania, Forenede Stater, 18017
        • Rekruttering
        • Lehigh Valley Hospital - Muhlenberg
        • Ledende efterforsker:
          • Christopher M. Reynolds
        • Kontakt:
      • Carlisle, Pennsylvania, Forenede Stater, 17015
        • Rekruttering
        • Carlisle Regional Cancer Center
        • Kontakt:
        • Ledende efterforsker:
          • Dan P. Zandberg
      • East Stroudsburg, Pennsylvania, Forenede Stater, 18301
        • Rekruttering
        • Pocono Medical Center
        • Ledende efterforsker:
          • Christopher M. Reynolds
        • Kontakt:
      • Erie, Pennsylvania, Forenede Stater, 16505
        • Rekruttering
        • UPMC Hillman Cancer Center Erie
        • Ledende efterforsker:
          • Dan P. Zandberg
        • Kontakt:
      • Greensburg, Pennsylvania, Forenede Stater, 15601
        • Rekruttering
        • UPMC Cancer Centers - Arnold Palmer Pavilion
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 724-838-1900
        • Ledende efterforsker:
          • Dan P. Zandberg
      • Harrisburg, Pennsylvania, Forenede Stater, 17109
        • Rekruttering
        • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
        • Kontakt:
        • Ledende efterforsker:
          • Dan P. Zandberg
      • Indiana, Pennsylvania, Forenede Stater, 15701
        • Rekruttering
        • IRMC Cancer Center
        • Kontakt:
        • Ledende efterforsker:
          • Dan P. Zandberg
      • Johnstown, Pennsylvania, Forenede Stater, 15901
        • Rekruttering
        • UPMC-Johnstown/John P. Murtha Regional Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 814-534-4724
        • Ledende efterforsker:
          • Dan P. Zandberg
      • Mechanicsburg, Pennsylvania, Forenede Stater, 17050
        • Rekruttering
        • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
        • Kontakt:
        • Ledende efterforsker:
          • Dan P. Zandberg
      • Monroeville, Pennsylvania, Forenede Stater, 15146
        • Rekruttering
        • UPMC Hillman Cancer Center - Monroeville
        • Ledende efterforsker:
          • Dan P. Zandberg
        • Kontakt:
      • Philadelphia, Pennsylvania, Forenede Stater, 19114
        • Aktiv, ikke rekrutterende
        • Jefferson Torresdale Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15215
        • Rekruttering
        • UPMC-Saint Margaret
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 412-784-4900
        • Ledende efterforsker:
          • Dan P. Zandberg
      • Pittsburgh, Pennsylvania, Forenede Stater, 15237
        • Rekruttering
        • UPMC-Passavant Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 412-367-6454
        • Ledende efterforsker:
          • Dan P. Zandberg
      • Pittsburgh, Pennsylvania, Forenede Stater, 15243
        • Rekruttering
        • UPMC-Saint Clair Hospital Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 412-502-3920
        • Ledende efterforsker:
          • Dan P. Zandberg
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • Rekruttering
        • UPMC Hillman Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 412-647-8073
        • Ledende efterforsker:
          • Dan P. Zandberg
      • Seneca, Pennsylvania, Forenede Stater, 16346
        • Rekruttering
        • UPMC Cancer Center at UPMC Northwest
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 814-676-7900
        • Ledende efterforsker:
          • Dan P. Zandberg
      • Uniontown, Pennsylvania, Forenede Stater, 15401
        • Rekruttering
        • UPMC Cancer Center-Uniontown
        • Kontakt:
        • Ledende efterforsker:
          • Dan P. Zandberg
      • Washington, Pennsylvania, Forenede Stater, 15301
        • Rekruttering
        • UPMC Cancer Center-Washington
        • Kontakt:
        • Ledende efterforsker:
          • Dan P. Zandberg
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Rekruttering
        • Medical University of South Carolina
        • Kontakt:
        • Ledende efterforsker:
          • John M. Kaczmar
    • South Dakota
      • Mitchell, South Dakota, Forenede Stater, 57301
        • Rekruttering
        • Avera Cancer Institute - Mitchell
        • Ledende efterforsker:
          • Benjamin M. Solomon
        • Kontakt:
      • Pierre, South Dakota, Forenede Stater, 57501
        • Rekruttering
        • Avera Cancer Institute at Pierre
        • Kontakt:
        • Ledende efterforsker:
          • Benjamin M. Solomon
      • Sioux Falls, South Dakota, Forenede Stater, 57104
      • Sioux Falls, South Dakota, Forenede Stater, 57117-5134
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Rekruttering
        • Avera Cancer Institute
        • Kontakt:
        • Ledende efterforsker:
          • Benjamin M. Solomon
      • Yankton, South Dakota, Forenede Stater, 57078
        • Rekruttering
        • Avera Cancer Institute at Yankton
        • Ledende efterforsker:
          • Benjamin M. Solomon
        • Kontakt:
    • Vermont
      • Saint Johnsbury, Vermont, Forenede Stater, 05819
        • Rekruttering
        • Dartmouth Cancer Center - North
        • Kontakt:
        • Ledende efterforsker:
          • Joerg Rathmann
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23235
        • Rekruttering
        • VCU Massey Cancer Center at Stony Point
        • Kontakt:
        • Ledende efterforsker:
          • Erin R. Alesi
      • Richmond, Virginia, Forenede Stater, 23298
        • Rekruttering
        • VCU Massey Comprehensive Cancer Center
        • Ledende efterforsker:
          • Erin R. Alesi
        • Kontakt:
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25304
        • Rekruttering
        • Vandalia Health/CAMC Institute for Academic Medicine
        • Ledende efterforsker:
          • Kok Hoe Chan
        • Kontakt:
    • Wisconsin
      • Burlington, Wisconsin, Forenede Stater, 53105
        • Rekruttering
        • Aurora Cancer Care-Southern Lakes VLCC
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Cudahy, Wisconsin, Forenede Stater, 53110
        • Rekruttering
        • Aurora Saint Luke's South Shore
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Eau Claire, Wisconsin, Forenede Stater, 54701
      • Germantown, Wisconsin, Forenede Stater, 53022
        • Rekruttering
        • Aurora Health Care Germantown Health Center
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Grafton, Wisconsin, Forenede Stater, 53024
        • Rekruttering
        • Aurora Cancer Care-Grafton
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Green Bay, Wisconsin, Forenede Stater, 54311
        • Rekruttering
        • Aurora BayCare Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Kenosha, Wisconsin, Forenede Stater, 53142
        • Rekruttering
        • Aurora Cancer Care-Kenosha South
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Rekruttering
        • Gundersen Lutheran Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Michael O. Ojelabi
      • Marinette, Wisconsin, Forenede Stater, 54143
        • Rekruttering
        • Aurora Bay Area Medical Group-Marinette
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Marshfield, Wisconsin, Forenede Stater, 54449
      • Milwaukee, Wisconsin, Forenede Stater, 53209
        • Rekruttering
        • Aurora Cancer Care-Milwaukee
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Rekruttering
        • Aurora Saint Luke's Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Milwaukee, Wisconsin, Forenede Stater, 53233
        • Rekruttering
        • Aurora Sinai Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Mukwonago, Wisconsin, Forenede Stater, 53149
        • Rekruttering
        • ProHealth D N Greenwald Center
        • Kontakt:
        • Ledende efterforsker:
          • Timothy R. Wassenaar
      • Oconomowoc, Wisconsin, Forenede Stater, 53066
        • Rekruttering
        • ProHealth Oconomowoc Memorial Hospital
        • Ledende efterforsker:
          • Timothy R. Wassenaar
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 262-928-7878
      • Oshkosh, Wisconsin, Forenede Stater, 54904
        • Rekruttering
        • Vince Lombardi Cancer Clinic - Oshkosh
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Racine, Wisconsin, Forenede Stater, 53406
        • Rekruttering
        • Aurora Cancer Care-Racine
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Rice Lake, Wisconsin, Forenede Stater, 54868
      • Sheboygan, Wisconsin, Forenede Stater, 53081
        • Rekruttering
        • Vince Lombardi Cancer Clinic-Sheboygan
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Stevens Point, Wisconsin, Forenede Stater, 54482
      • Summit, Wisconsin, Forenede Stater, 53066
        • Rekruttering
        • Aurora Medical Center in Summit
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Two Rivers, Wisconsin, Forenede Stater, 54241
        • Rekruttering
        • Vince Lombardi Cancer Clinic-Two Rivers
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • Rekruttering
        • ProHealth Waukesha Memorial Hospital
        • Ledende efterforsker:
          • Timothy R. Wassenaar
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 262-928-7632
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • Rekruttering
        • UW Cancer Center at ProHealth Care
        • Ledende efterforsker:
          • Timothy R. Wassenaar
        • Kontakt:
      • Wauwatosa, Wisconsin, Forenede Stater, 53226
        • Rekruttering
        • Aurora Cancer Care-Milwaukee West
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • West Allis, Wisconsin, Forenede Stater, 53227
        • Rekruttering
        • Aurora West Allis Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Peter J. Polewski
      • Weston, Wisconsin, Forenede Stater, 54476

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 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.

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm 1 (pembrolizumab)

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.

Undergo blood sample collection

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion

Undergo MRI

Andre navne:
  • MR
  • Magnetisk resonans
  • Magnetisk resonansbilledscanning
  • Medicinsk billeddannelse, magnetisk resonans / kernemagnetisk resonans
  • HR
  • MR billeddannelse
  • MR-scanning
  • NMR billeddannelse
  • NMRI
  • Kernemagnetisk resonansbilleddannelse
  • Magnetisk resonansbilleddannelse (MRI)
  • sMRI
  • Magnetisk resonansbilleddannelse (procedure)
  • MRI'er
  • Strukturel MR

Given IV

Andre navne:
  • Keytruda
  • MK-3475
  • Lambrolizumab
  • SCH 900475
  • MK3475
  • SCH-900475
  • BCD-201
  • Pembrolizumab Biosimilar BCD-201
  • Pembrolizumab Biosimilar QL2107
  • QL2107
  • GME 751
  • GME751
  • Pembrolizumab Biosimilar GME751
  • MK 3475
  • SCH900475
  • Pembrolizumab Biosimilar RPH-075
  • RPH 075
  • RPH-075
  • RPH075
  • Pembrolizumab Biosimilar SB27
  • SB 27
  • SB-27
  • SB27

Undergo CT or PET/CT

Andre navne:
  • CT
  • KAT
  • CAT-scanning
  • Beregnet aksial tomografi
  • Computerstyret aksial tomografi
  • Computerstyret tomografi
  • CT-scanning
  • tomografi
  • Computerstyret aksial tomografi (procedure)
  • Computerstyret tomografi (CT) scanning
  • Diagnostisk CAT -scanning
  • Diagnostic CAT Scan Service Type

Undergo PET/CT

Andre navne:
  • Medicinsk billeddannelse, Positron Emission Tomografi
  • KÆLEDYR
  • PET-scanning
  • Positron Emission Tomografi Scan
  • Positron-emissionstomografi
  • PT
  • Positron emissionstomografi (procedure)
Eksperimentel: Arm 2 (cetuximab, pembrolizumab)

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.

Undergo blood sample collection

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion

Undergo MRI

Andre navne:
  • MR
  • Magnetisk resonans
  • Magnetisk resonansbilledscanning
  • Medicinsk billeddannelse, magnetisk resonans / kernemagnetisk resonans
  • HR
  • MR billeddannelse
  • MR-scanning
  • NMR billeddannelse
  • NMRI
  • Kernemagnetisk resonansbilleddannelse
  • Magnetisk resonansbilleddannelse (MRI)
  • sMRI
  • Magnetisk resonansbilleddannelse (procedure)
  • MRI'er
  • Strukturel MR

Given IV

Andre navne:
  • Keytruda
  • MK-3475
  • Lambrolizumab
  • SCH 900475
  • MK3475
  • SCH-900475
  • BCD-201
  • Pembrolizumab Biosimilar BCD-201
  • Pembrolizumab Biosimilar QL2107
  • QL2107
  • GME 751
  • GME751
  • Pembrolizumab Biosimilar GME751
  • MK 3475
  • SCH900475
  • Pembrolizumab Biosimilar RPH-075
  • RPH 075
  • RPH-075
  • RPH075
  • Pembrolizumab Biosimilar SB27
  • SB 27
  • SB-27
  • SB27

Undergo CT or PET/CT

Andre navne:
  • CT
  • KAT
  • CAT-scanning
  • Beregnet aksial tomografi
  • Computerstyret aksial tomografi
  • Computerstyret tomografi
  • CT-scanning
  • tomografi
  • Computerstyret aksial tomografi (procedure)
  • Computerstyret tomografi (CT) scanning
  • Diagnostisk CAT -scanning
  • Diagnostic CAT Scan Service Type

Undergo PET/CT

Andre navne:
  • Medicinsk billeddannelse, Positron Emission Tomografi
  • KÆLEDYR
  • PET-scanning
  • Positron Emission Tomografi Scan
  • Positron-emissionstomografi
  • PT
  • Positron emissionstomografi (procedure)

Given IV

Andre navne:
  • C225
  • Erbitux
  • IMC-C225
  • Cetuximab Biosimilar CDP-1
  • Cetuximab Biosimilar CMAB009
  • Cetuximab Biosimilar KL 140
  • Kimærisk anti-EGFR monoklonalt antistof
  • Kimærisk MoAb C225
  • Kimært monoklonalt antistof C225
  • C-225
  • C 225
  • Cetuximab-cetu
  • Cetuxa
  • ENZ 124
  • ENZ-124
  • ENZ124

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall survival (OS)
Tidsramme: Time from randomization to death from any cause, assessed up to 5 years

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.

Time from randomization to death from any cause, assessed up to 5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Confirmed response rate
Tidsramme: Up to 5 years

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.

Up to 5 years
Duration of response
Tidsramme: 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

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.

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
Tidsramme: Time from randomization to the first of either disease progression or death from any cause, assessed up to 5 years

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.

Time from randomization to the first of either disease progression or death from any cause, assessed up to 5 years
Incidence of adverse events
Tidsramme: Up to 5 years

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.

Up to 5 years
Patient-reported toxicity
Tidsramme: Up to 5 years

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.

Up to 5 years

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Estimates of median OS by sex
Tidsramme: Up to 5 years

Estimates of treatment effects (median OS) and the corresponding 95% confidence intervals will be provided by sex.

Up to 5 years
Estimates of median OS by race
Tidsramme: Up to 5 years

Estimates of treatment effects (median OS) and the corresponding 95% confidence intervals will be provided by race.

Up to 5 years
Estimates of median OS by ethnicity
Tidsramme: Up to 5 years

Estimates of treatment effects (median OS) and the corresponding 95% confidence intervals will be provided by ethnicity.

Up to 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Siddharth Sheth, Alliance for Clinical Trials in Oncology

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. marts 2025

Primær færdiggørelse (Anslået)

25. december 2032

Studieafslutning (Anslået)

25. december 2032

Datoer for studieregistrering

Først indsendt

6. september 2024

Først indsendt, der opfyldte QC-kriterier

6. september 2024

Først opslået (Faktiske)

19. september 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • NCI-2024-07339
  • U10CA180821 (U.S. NIH-bevilling/kontrakt)
  • NCI-2024-07339 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • A092205 (Anden identifikator: CTEP)
  • A092205 (Anden identifikator: Alliance for Clinical Trials in Oncology)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .