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Testen der Ergänzung eines Immuntherapeutikums, Cemiplimab (REGN2810), plus einer Operation zur üblichen Operation allein zur Behandlung von fortgeschrittenem Hautkrebs

31. Oktober 2026 aktualisiert von: National Cancer Institute (NCI)

Randomisierte Phase-III-Studie zur perioperativen Immuntherapie mit an das Ansprechen angepasster Behandlung im Vergleich zur Standardbehandlung für resektables kutanes Plattenepithelkarzinom im Stadium III/IV

This phase III trial compares the effect of adding cemiplimab to standard therapy (surgery with or without radiation) versus standard therapy alone in treating patients with stage III/IV squamous cell skin cancer that is able to be removed by surgery (resectable) and that may have come back after a period of improvement (recurrent). The usual treatment for patients with resectable squamous cell skin cancer is the removal of the cancerous tissue (surgery) with or without radiation, which uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cemiplimab has been approved for the treatment of skin cancer that has spread or that cannot be removed by surgery, but it has not been approved for the treatment of skin cancer than can be removed by surgery. Adding cemiplimab to the usual treatment of surgery with or without radiation may be more effective in treating patients with stage III/IV resectable squamous cell skin cancer than the usual treatment alone.

Studienübersicht

Status

Suspendiert

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

PRIMARY OBJECTIVE:

I. To determine if neoadjuvant immunotherapy combined with response-adapted oncologic surgery improves site-reported event-free survival (EFS) compared to standard-of-care surgery in resectable stage III/IV cutaneous squamous cell carcinoma (CSCC).

SECONDARY OBJECTIVES:

I. To compare utilization of adjuvant radiation between arms. II. To compare disease-free survival (DFS) between arms. III. To compare overall survival (OS) between arms. IV. To compare adverse events (Common Terminology Criteria for Adverse Events [CTCAE] version [v]5.0) between arms.

V. To assess pathologic complete response in arm 2.

PATIENT-REPORTED OUTCOMES:

I. Compare changes in patient reported quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) at 1, 6, and 12 months after surgery between treatment arms. (Primary objective) II. To compare patient reported symptoms functioning, and quality of life, as measured by the Cutaneous Squamous Cell Carcinoma NeoAdjuvant, Adjuvant and Perioperative 32 question scale (CSCC NAAP-32), Patient Reported Outcomes Measurement Information System (PROMIS)-Short Form (SF)-Anxiety, PROMIS-SF-Fatigue, and EuroQol-5D (EQ-5D), between arms at 1, 6, and 12 months after surgery.

III. Develop a scoring algorithm and validate the CSCC-NAAP-32 for use in this patient population.

EXPLORATORY OBJECTIVES:

I. To compare disease-specific survival (DSS) between arms. II. To correlate pathologic response with DFS in arm 2. III. To assess overall response rate (ORR) in arm 2. IV. To compare patterns of failure between arms. V. To compare pathologic measurements of lymph node yield between arms. VI. To compare primary tumor specimen dimensions and volume between arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients undergo surgery per standard of care within 6 weeks of randomization. Starting within 6-12 weeks of surgery, patients may undergo image-guided radiation therapy (IGRT) with intensity modulated radiation therapy (IMRT) for 5 fractions per week for 6 weeks as clinically indicated. Patients also undergo computed tomography (CT), magnetic resonance imaging (MRI), and/or positron emission tomography (PET)/CT prior to treatment, and CT and/or MRI during follow up. Patients may also undergo optional collection of tissue, whole blood, and plasma on study.

ARM 2: Patients receive cemiplimab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo response-adaptive surgery 21 days after last dose of cemiplimab. Starting within 12 weeks of surgery, patients may undergo IGRT with IMRT for 5 fractions per week for 6 weeks as clinically indicated. Starting within 6 weeks of completion of surgery or radiation therapy (if indicated), patients without pathologic complete response (pCR) receive cemiplimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or PET/CT prior to treatment, and CT and/or MRI on study and during follow up. Patients may also undergo optional collection of tissue, whole blood, and plasma on study.

After completion of study treatment, patients are followed up at 1, 6, and 12 months post-surgery then every 3 months for 2 years, every 6 months in year 3, and then annually thereafter.

Studientyp

Interventionell

Einschreibung (Geschätzt)

420

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Australien
    • New South Wales
      • Camperdown, New South Wales, Australien, 2050
        • Chris O'Brien Lifehouse
      • Wollongong, New South Wales, Australien, 2500
        • Wollongong Hospital
    • Queensland
      • Townsville, Queensland, Australien, 4814
        • Townsville General Hospital
      • Woolloongabba, Queensland, Australien, 4102
        • Princess Alexandra Hospital
    • Victoria
      • Fitzroy, Victoria, Australien, 3065
        • Saint Vincent's Hospital
      • Melbourne, Victoria, Australien, 3000
        • Peter MacCallum Cancer Centre
    • Western Australia
      • Murdoch, Western Australia, Australien, 6150
        • Fiona Stanley Hospital
  • Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada, V5Z 4E6
        • BCCA-Vancouver Cancer Centre
    • Ontario
      • Toronto, Ontario, Kanada, M5G 2M9
        • University Health Network-Princess Margaret Hospital
      • Toronto, Ontario, Kanada, M4N 3M5
        • Odette Cancer Centre- Sunnybrook Health Sciences Centre
  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35233
        • University of Alabama at Birmingham Cancer Center
    • Arizona
      • Gilbert, Arizona, Vereinigte Staaten, 85234
        • Banner MD Anderson Cancer Center
      • Phoenix, Arizona, Vereinigte Staaten, 85054
        • Mayo Clinic Hospital in Arizona
    • California
      • Beverly Hills, California, Vereinigte Staaten, 90211
        • Tower Cancer Research Foundation
      • Duarte, California, Vereinigte Staaten, 91010
        • City of Hope Comprehensive Cancer Center
      • Encinitas, California, Vereinigte Staaten, 92024
        • UC San Diego Health System - Encinitas
      • Irvine, California, Vereinigte Staaten, 92618
        • City of Hope at Irvine Lennar
      • La Jolla, California, Vereinigte Staaten, 92093
        • UC San Diego Moores Cancer Center
      • Lancaster, California, Vereinigte Staaten, 93534
        • City of Hope Antelope Valley
      • Los Angeles, California, Vereinigte Staaten, 90033
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, Vereinigte Staaten, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, Vereinigte Staaten, 90025
        • The Angeles Clinic and Research Institute - West Los Angeles Office
      • Oakland, California, Vereinigte Staaten, 94611
        • Kaiser Permanente-Oakland
      • Palo Alto, California, Vereinigte Staaten, 94304
        • Stanford Cancer Institute Palo Alto
      • Sacramento, California, Vereinigte Staaten, 95817
        • University of California Davis Comprehensive Cancer Center
      • Sacramento, California, Vereinigte Staaten, 95823
        • Kaiser Permanente-South Sacramento
      • San Diego, California, Vereinigte Staaten, 92103
        • UC San Diego Medical Center - Hillcrest
      • San Francisco, California, Vereinigte Staaten, 94115
        • Kaiser Permanente-San Francisco
      • South Pasadena, California, Vereinigte Staaten, 91030
        • City of Hope South Pasadena
      • Torrance, California, Vereinigte Staaten, 90505
        • Torrance Memorial Physician Network - Cancer Care
      • Upland, California, Vereinigte Staaten, 91786
        • City of Hope Upland
      • Walnut Creek, California, Vereinigte Staaten, 94596
        • Kaiser Permanente-Walnut Creek
    • Colorado
      • Aurora, Colorado, Vereinigte Staaten, 80045
        • UCHealth University of Colorado Hospital
      • Colorado Springs, Colorado, Vereinigte Staaten, 80909
        • UCHealth Memorial Hospital Central
      • Colorado Springs, Colorado, Vereinigte Staaten, 80920
        • Memorial Hospital North
    • Connecticut
      • Greenwich, Connecticut, Vereinigte Staaten, 06830
        • Smilow Cancer Hospital Care Center at Greenwich
      • Guilford, Connecticut, Vereinigte Staaten, 06437
        • Smilow Cancer Hospital Care Center - Guilford
      • New Haven, Connecticut, Vereinigte Staaten, 06520
        • Yale University
      • Trumbull, Connecticut, Vereinigte Staaten, 06611
        • Smilow Cancer Hospital Care Center-Trumbull
      • Waterbury, Connecticut, Vereinigte Staaten, 06708
        • Smilow Cancer Hospital-Waterbury Care Center
      • Waterford, Connecticut, Vereinigte Staaten, 06385
        • Smilow Cancer Hospital Care Center - Waterford
    • Delaware
      • Newark, Delaware, Vereinigte Staaten, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, Vereinigte Staaten, 19713
        • Medical Oncology Hematology Consultants PA
    • Florida
      • Aventura, Florida, Vereinigte Staaten, 33180
        • UM Sylvester Comprehensive Cancer Center at Aventura
      • Coral Gables, Florida, Vereinigte Staaten, 33146
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
      • Deerfield Beach, Florida, Vereinigte Staaten, 33442
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
      • Doral, Florida, Vereinigte Staaten, 33166
        • UM Sylvester Comprehensive Cancer Center at Doral
      • Jacksonville, Florida, Vereinigte Staaten, 32224-9980
        • Mayo Clinic in Florida
      • Miami, Florida, Vereinigte Staaten, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Miami, Florida, Vereinigte Staaten, 33176
        • Miami Cancer Institute
      • Miami, Florida, Vereinigte Staaten, 33176
        • UM Sylvester Comprehensive Cancer Center at Kendall
      • N. Venice, Florida, Vereinigte Staaten, 34275
        • Sarasota Memorial Hospital-Venice
      • Plantation, Florida, Vereinigte Staaten, 33324
        • UM Sylvester Comprehensive Cancer Center at Plantation
      • Sarasota, Florida, Vereinigte Staaten, 34239
        • Sarasota Memorial Hospital
      • Sarasota, Florida, Vereinigte Staaten, 34232
        • Florida Cancer Specialists - Sarasota
      • Sarasota, Florida, Vereinigte Staaten, 34243
        • Sarasota Memorial Health Care Center at University Parkway
      • Sarasota, Florida, Vereinigte Staaten, 34239
        • First Physicians Group - Silverstein Institute at Floyd Street
      • Sarasota, Florida, Vereinigte Staaten, 34239
        • Florida Cancer Specialists - Sarasota Downtown
      • Tampa, Florida, Vereinigte Staaten, 33612
        • Moffitt Cancer Center
      • Tampa, Florida, Vereinigte Staaten, 33607
        • Moffitt Cancer Center-International Plaza
      • Tampa, Florida, Vereinigte Staaten, 33612
        • Moffitt Cancer Center - McKinley Campus
      • Venice, Florida, Vereinigte Staaten, 34285
        • Florida Cancer Specialists - Venice Island
      • Venice, Florida, Vereinigte Staaten, 34275
        • Florida Cancer Specialists - Venice Pinebrook
    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, Vereinigte Staaten, 30322
        • Emory University Hospital/Winship Cancer Institute
    • Illinois
      • Alton, Illinois, Vereinigte Staaten, 62002
        • Alton Memorial Hospital
      • Chicago, Illinois, Vereinigte Staaten, 60611
        • Northwestern University
      • Chicago, Illinois, Vereinigte Staaten, 60612
        • University of Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60612
        • Rush MD Anderson Cancer Center
      • DeKalb, Illinois, Vereinigte Staaten, 60115
        • Northwestern Medicine Cancer Center Kishwaukee
      • Decatur, Illinois, Vereinigte Staaten, 62526
        • Decatur Memorial Hospital
      • Geneva, Illinois, Vereinigte Staaten, 60134
        • Northwestern Medicine Cancer Center Delnor
      • Orland Park, Illinois, Vereinigte Staaten, 60462
        • Northwestern Medicine Orland Park
      • Shiloh, Illinois, Vereinigte Staaten, 62269
        • Memorial Hospital East
      • Warrenville, Illinois, Vereinigte Staaten, 60555
        • Northwestern Medicine Cancer Center Warrenville
    • Indiana
      • Carmel, Indiana, Vereinigte Staaten, 46032
        • IU Health North Hospital
      • Goshen, Indiana, Vereinigte Staaten, 46526
        • Goshen Center for Cancer Care
      • Indianapolis, Indiana, Vereinigte Staaten, 46237
        • Franciscan Health Indianapolis
      • Indianapolis, Indiana, Vereinigte Staaten, 46202
        • Indiana University/Melvin and Bren Simon Cancer Center
    • Iowa
      • Council Bluffs, Iowa, Vereinigte Staaten, 51503
        • Heartland Oncology and Hematology LLP
      • Council Bluffs, Iowa, Vereinigte Staaten, 51503
        • Methodist Jennie Edmundson Hospital
    • Kansas
      • Kansas City, Kansas, Vereinigte Staaten, 66160
        • University of Kansas Cancer Center
      • Overland Park, Kansas, Vereinigte Staaten, 66210
        • University of Kansas Cancer Center-Overland Park
      • Overland Park, Kansas, Vereinigte Staaten, 66211
        • University of Kansas Hospital-Indian Creek Campus
      • Westwood, Kansas, Vereinigte Staaten, 66205
        • University of Kansas Hospital-Westwood Cancer Center
    • Kentucky
      • Lexington, Kentucky, Vereinigte Staaten, 40536
        • University of Kentucky/Markey Cancer Center
      • Louisville, Kentucky, Vereinigte Staaten, 40202
        • The James Graham Brown Cancer Center at University of Louisville
      • Louisville, Kentucky, Vereinigte Staaten, 40245
        • UofL Health Medical Center Northeast
    • Louisiana
      • Baton Rouge, Louisiana, Vereinigte Staaten, 70805
        • LSU Health Baton Rouge-North Clinic
      • Baton Rouge, Louisiana, Vereinigte Staaten, 70808
        • Our Lady of the Lake Physician Group
      • New Orleans, Louisiana, Vereinigte Staaten, 70112
        • University Medical Center New Orleans
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48109
        • University of Michigan Rogel Cancer Center
      • Brighton, Michigan, Vereinigte Staaten, 48116
        • University of Michigan - Brighton Center for Specialty Care
      • Detroit, Michigan, Vereinigte Staaten, 48202
        • Henry Ford Hospital
      • Grand Rapids, Michigan, Vereinigte Staaten, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • West Bloomfield, Michigan, Vereinigte Staaten, 48322
        • Henry Ford West Bloomfield Hospital
      • Wyoming, Michigan, Vereinigte Staaten, 49519
        • University of Michigan Health - West
    • Minnesota
      • Minneapolis, Minnesota, Vereinigte Staaten, 55455
        • University of Minnesota/Masonic Cancer Center
      • Rochester, Minnesota, Vereinigte Staaten, 55905
        • Mayo Clinic in Rochester
    • Missouri
      • City of Saint Peters, Missouri, Vereinigte Staaten, 63376
        • Siteman Cancer Center at Saint Peters Hospital
      • Columbia, Missouri, Vereinigte Staaten, 65212
        • MU Health - University Hospital/Ellis Fischel Cancer Center
      • Creve Coeur, Missouri, Vereinigte Staaten, 63141
        • Siteman Cancer Center at West County Hospital
      • Kansas City, Missouri, Vereinigte Staaten, 64154
        • University of Kansas Cancer Center - North
      • Lee's Summit, Missouri, Vereinigte Staaten, 64064
        • University of Kansas Cancer Center - Lee's Summit
      • St Louis, Missouri, Vereinigte Staaten, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, Vereinigte Staaten, 63129
        • Siteman Cancer Center-South County
      • St Louis, Missouri, Vereinigte Staaten, 63136
        • Siteman Cancer Center at Christian Hospital
    • Nebraska
      • Bellevue, Nebraska, Vereinigte Staaten, 68123
        • Nebraska Medicine-Bellevue
      • Omaha, Nebraska, Vereinigte Staaten, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, Vereinigte Staaten, 68198
        • University of Nebraska Medical Center
      • Omaha, Nebraska, Vereinigte Staaten, 68118
        • Nebraska Medicine-Village Pointe
      • Omaha, Nebraska, Vereinigte Staaten, 68114
        • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
    • New Hampshire
      • Lebanon, New Hampshire, Vereinigte Staaten, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
    • New Jersey
      • Basking Ridge, New Jersey, Vereinigte Staaten, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Middletown, New Jersey, Vereinigte Staaten, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, Vereinigte Staaten, 07645
        • Memorial Sloan Kettering Bergen
    • New Mexico
      • Albuquerque, New Mexico, Vereinigte Staaten, 87106
        • University of New Mexico Cancer Center
    • New York
      • Commack, New York, Vereinigte Staaten, 11725
        • Memorial Sloan Kettering Commack
      • Harrison, New York, Vereinigte Staaten, 10604
        • Memorial Sloan Kettering Westchester
      • Lake Success, New York, Vereinigte Staaten, 11042
        • Northwell Health/Center for Advanced Medicine
      • Mineola, New York, Vereinigte Staaten, 11501
        • NYU Langone Hospital - Long Island
      • New York, New York, Vereinigte Staaten, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, Vereinigte Staaten, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • New York, New York, Vereinigte Staaten, 10075
        • Lenox Hill Hospital
      • New York, New York, Vereinigte Staaten, 10065
        • Manhattan Eye Ear and Throat Hospital
      • Rochester, New York, Vereinigte Staaten, 14642
        • University of Rochester
      • Stony Brook, New York, Vereinigte Staaten, 11794
        • Stony Brook University Medical Center
      • Syracuse, New York, Vereinigte Staaten, 13210
        • State University of New York Upstate Medical University
      • Syracuse, New York, Vereinigte Staaten, 13215
        • SUNY Upstate Medical Center-Community Campus
      • The Bronx, New York, Vereinigte Staaten, 10461
        • Montefiore Medical Center-Einstein Campus
      • The Bronx, New York, Vereinigte Staaten, 10467
        • Montefiore Medical Center - Moses Campus
      • The Bronx, New York, Vereinigte Staaten, 10461
        • Montefiore Medical Center-Weiler Hospital
      • Uniondale, New York, Vereinigte Staaten, 11553
        • Memorial Sloan Kettering Nassau
      • Webster, New York, Vereinigte Staaten, 14580
        • Wilmot Cancer Institute at Webster
    • North Carolina
      • Albemarle, North Carolina, Vereinigte Staaten, 28002
        • Atrium Health Stanly/LCI-Albemarle
      • Chapel Hill, North Carolina, Vereinigte Staaten, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Charlotte, North Carolina, Vereinigte Staaten, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Charlotte, North Carolina, Vereinigte Staaten, 28210
        • Atrium Health Pineville/LCI-Pineville
      • Charlotte, North Carolina, Vereinigte Staaten, 28262
        • Atrium Health University City/LCI-University
      • Concord, North Carolina, Vereinigte Staaten, 28025
        • Atrium Health Cabarrus/LCI-Concord
      • Durham, North Carolina, Vereinigte Staaten, 27710
        • Duke University Medical Center
      • Gastonia, North Carolina, Vereinigte Staaten, 28054
        • Levine Cancer Institute-Gaston
      • Monroe, North Carolina, Vereinigte Staaten, 28112
        • Atrium Health Union/LCI-Union
      • Raleigh, North Carolina, Vereinigte Staaten, 27609
        • Duke Cancer Center Raleigh
      • Shelby, North Carolina, Vereinigte Staaten, 28150
        • Atrium Health Cleveland/LCI-Cleveland
      • Winston-Salem, North Carolina, Vereinigte Staaten, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Avon, Ohio, Vereinigte Staaten, 44011
        • UH Seidman Cancer Center at UH Avon Health Center
      • Beachwood, Ohio, Vereinigte Staaten, 44122
        • UHHS-Chagrin Highlands Medical Center
      • Centerville, Ohio, Vereinigte Staaten, 45459
        • Miami Valley Hospital South
      • Cincinnati, Ohio, Vereinigte Staaten, 45219
        • University of Cincinnati Cancer Center-UC Medical Center
      • Cleveland, Ohio, Vereinigte Staaten, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, Vereinigte Staaten, 44109
        • MetroHealth Medical Center
      • Columbus, Ohio, Vereinigte Staaten, 43210
        • Ohio State University Comprehensive Cancer Center
      • Dayton, Ohio, Vereinigte Staaten, 45415
        • Miami Valley Hospital North
      • Franklin, Ohio, Vereinigte Staaten, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Greenville, Ohio, Vereinigte Staaten, 45331
        • Miami Valley Cancer Care and Infusion
      • Mentor, Ohio, Vereinigte Staaten, 44060
        • UH Seidman Cancer Center at Lake Health Mentor Campus
      • Troy, Ohio, Vereinigte Staaten, 45373
        • Upper Valley Medical Center
      • West Chester, Ohio, Vereinigte Staaten, 45069
        • University of Cincinnati Cancer Center-West Chester
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97213
        • Providence Portland Medical Center
    • Pennsylvania
      • Chadds Ford, Pennsylvania, Vereinigte Staaten, 19317
        • Christiana Care Health System-Concord Health Center
      • Erie, Pennsylvania, Vereinigte Staaten, 16505
        • UPMC Hillman Cancer Center Erie
      • Erie, Pennsylvania, Vereinigte Staaten, 16544
        • Saint Vincent Hospital
      • Hershey, Pennsylvania, Vereinigte Staaten, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Johnstown, Pennsylvania, Vereinigte Staaten, 15901
        • UPMC-Johnstown/John P. Murtha Regional Cancer Center
      • Monroeville, Pennsylvania, Vereinigte Staaten, 15146
        • Forbes Hospital
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15224
        • West Penn Hospital
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15232
        • UPMC Hillman Cancer Center
      • Wexford, Pennsylvania, Vereinigte Staaten, 15090
        • Wexford Health and Wellness Pavilion
    • South Carolina
      • Charleston, South Carolina, Vereinigte Staaten, 29425
        • Medical University of South Carolina
      • Rock Hill, South Carolina, Vereinigte Staaten, 29732
        • Levine Cancer Institute-Rock Hill
      • Rock Hill, South Carolina, Vereinigte Staaten, 29730
        • Rock Hill Radiation Therapy Center
    • Tennessee
      • Nashville, Tennessee, Vereinigte Staaten, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Conroe, Texas, Vereinigte Staaten, 77384
        • UT MD Anderson - The Woodlands
      • Dallas, Texas, Vereinigte Staaten, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Dallas, Texas, Vereinigte Staaten, 75237
        • UT Southwestern Simmons Cancer Center - RedBird
      • Fort Worth, Texas, Vereinigte Staaten, 76104
        • UT Southwestern/Simmons Cancer Center-Fort Worth
      • Houston, Texas, Vereinigte Staaten, 77030
        • UT MD Anderson Cancer Center
      • Houston, Texas, Vereinigte Staaten, 77079
        • UT MD Anderson - West Houston
      • League City, Texas, Vereinigte Staaten, 77573
        • UT MD Anderson - League City
      • Richardson, Texas, Vereinigte Staaten, 75080
        • UT Southwestern Clinical Center at Richardson/Plano
      • San Antonio, Texas, Vereinigte Staaten, 78229
        • University of Texas Health Science Center at San Antonio
      • Sugar Land, Texas, Vereinigte Staaten, 77478
        • UT MD Anderson - Sugar Land
    • Utah
      • Salt Lake City, Utah, Vereinigte Staaten, 84112
        • Huntsman Cancer Institute/University of Utah
    • Vermont
      • Berlin Corners, Vermont, Vereinigte Staaten, 05602
        • Central Vermont Medical Center/National Life Cancer Treatment
      • Burlington, Vermont, Vereinigte Staaten, 05401
        • University of Vermont Medical Center
      • Burlington, Vermont, Vereinigte Staaten, 05405
        • University of Vermont and State Agricultural College
      • Saint Johnsbury, Vermont, Vereinigte Staaten, 05819
        • Dartmouth Cancer Center - North
    • Virginia
      • Charlottesville, Virginia, Vereinigte Staaten, 22908
        • University of Virginia Cancer Center
      • Fairfax, Virginia, Vereinigte Staaten, 22031
        • Inova Schar Cancer Institute
      • Richmond, Virginia, Vereinigte Staaten, 23298
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Seattle, Washington, Vereinigte Staaten, 98101
        • Virginia Mason Medical Center
    • Wisconsin
      • La Crosse, Wisconsin, Vereinigte Staaten, 54601
        • Gundersen Lutheran Medical Center
      • Madison, Wisconsin, Vereinigte Staaten, 53705
        • William S Middleton VA Medical Center
      • Madison, Wisconsin, Vereinigte Staaten, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Madison, Wisconsin, Vereinigte Staaten, 53718
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
      • Marshfield, Wisconsin, Vereinigte Staaten, 54449
        • Marshfield Medical Center-Marshfield
      • Menomonee Falls, Wisconsin, Vereinigte Staaten, 53051
        • Froedtert Menomonee Falls Hospital
      • Milwaukee, Wisconsin, Vereinigte Staaten, 53226
        • Medical College of Wisconsin
      • Oak Creek, Wisconsin, Vereinigte Staaten, 53154
        • Drexel Town Square Health Center
      • West Bend, Wisconsin, Vereinigte Staaten, 53095
        • Froedtert West Bend Hospital/Kraemer Cancer Center
      • Weston, Wisconsin, Vereinigte Staaten, 54476
        • Marshfield Medical Center - Weston

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of invasive cutaneous squamous cell carcinoma (CSCC) or regional lymph node or in-transit metastasis of CSCC

    • The following CSCC subtypes are eligible according to World Health Organization (WHO) classification if the predominant histology is confirmed CSCC.

      • Spindle cell squamous cell carcinoma (SCC)

      • Squamous cell carcinoma with sarcomatoid differentiation

      • Acantholytic SCC

      • Clear cell SCC

      • Lymphoepithelial carcinoma

        • Note: Keratoacanthoma SCC and Verrucous SCC subtypes are not eligible.

    • For patients with regional metastasis without a primary tumor at screening: a clinical history of CSCC that drains to the involved regional lymph nodes or in-transit metastases in question is required

      • For example, a parotid mass shown to be SCC by cytologic analysis of a fine needle aspirate in a patient with a clinical history of CSCC on the ipsilateral scalp would be eligible

    • For patients with regional metastases without a primary tumor and an ambiguous clinical history: tumor genomic sequencing suggesting a primary tumor of cutaneous origin would be acceptable evidence to establish eligibility

    • NOTE: Tumor genomic sequencing is not required to determine eligibility, but may be part of the routine evaluation of patients with cancers of unknown primary at some institutions. For example, a parotid mass shown to be SCC by cytologic analysis of fine needle aspirate without a primary tumor and an ambiguous clinical history, but with a tumor genomic sequencing assay demonstrating a high tumor mutation burden (≥ 10 mutations/Mb) and/or a high fraction of ultraviolet (UV) related mutations (> 50% of mutations [cytosine (C)/thymine (T)]C > T or CC > TT) and/or the presence of "signature 7" mutations would be eligible (Chang 2021)

  • Previously untreated or recurrent CSCC

  • Clinical American Joint Committee on Cancer (AJCC) 8th Edition (eyelid, head and neck sites) or Union for International Cancer Control (UICC) (non-head and neck sites) stage III or IV

  • Primary tumor site must be in the head and neck cutaneous region, other non-head and neck cutaneous regions, or eyelid cutaneous region

  • No mucosal squamous cell carcinoma (vermillion lip, nasal, oral, sinonasal, conjunctival, anogenital)

  • Tumor must be resectable with curative intent. Note: Tumor with bony skull base invasion and/or skull base foramen involvement (T4b) is not eligible. (Patients with T4b eyelid tumors using UICC Staging, and not involving the brain, are eligible.)

  • At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  • No definitive clinical or radiologic evidence of distant metastatic disease (M1), visceral and/or distant nodal disease

  • Age ≥ 18

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

  • Not pregnant and not nursing

    • Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal

  • Absolute neutrophil count (ANC) ≥ 1,000 cells/mm^3

  • Platelets ≥ 75,000 cells/mm^3

  • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] ≥ 8.0 g/dl is acceptable)

  • Creatinine clearance (CrCL) > 30mL/min by the Cockcroft-Gault formula

  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (NOTE: For patients with Gilbert's syndrome, total bilirubin ≤ 3 x ULN. Gilbert's syndrome must be documented appropriately as past medical history.)

  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3 x institutional ULN

  • No prior systemic therapy for the study cancer (including patients currently receiving immunotherapy for a separate malignancy)

  • No prior radiotherapy to the region of the study cancer that would result in cumulative doses of radiation to organs at risk for radiation injury that exceed protocol limitations

  • No history of myocardial infarction/unstable angina within the last 6 months

  • New York Heart Association functional classification IIb or better (New York Heart Association [NYHA] functional classification III/IV are not eligible) (Note: 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)

  • No active infection requiring systemic antibiotics, antiviral, or antifungal treatments

  • No history of allogeneic stem cell transplantation, or autologous stem cell transplantation

  • No history of a solid organ transplant (other than corneal transplant)

  • No active, known, or suspected autoimmune disease

    • Active or known disease is defined as:

      • Requiring higher than physiologic steroid levels (> 10mg prednisone/day or equivalent) or
      • Requiring disease-modifying agents or
      • Ongoing or recent (within 5 years prior to registration) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs)

    • NOTES:

      • Patients meeting the following criteria are not considered immunosuppressed and are eligible to enroll:

        • Patients who require a brief course of steroids (eg, prophylaxis for imaging assessments due to hypersensitivity to contrast agents) are not excluded
        • Patients with type I diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
        • Physiologic replacement doses ≤ 10 mg prednisone/day or equivalent allowed, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted

      • Patients with the following immunosuppressed conditions are eligible to enroll:

        • Patients with HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible
        • Patients with chronic lymphocytic leukemia (CLL) with no history of anti-CLL therapy within 6 months prior to registration are eligible

  • No history of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia)

  • No active, noninfectious pneumonitis requiring immune-suppressive therapy

  • No active tuberculosis

  • No live vaccines within 28 days prior to registration

  • No history of allergic reaction to the study agent, compounds of similar chemical or biologic composition to the study agent (or any of its excipients)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Arm 1 (surgery, radiation)

Patients undergo surgery per standard of care within 6 weeks of randomization. Starting within 6-12 weeks of surgery, patients may undergo IGRT with IMRT for 5 fractions per week for 6 weeks as clinically indicated. Patients also undergo CT, MRI, and/or PET/CT prior to treatment, and CT and/or MRI during follow up. Patients may also undergo optional collection of tissue, whole blood, and plasma on study.
Verfahren: Magnetic Resonance Imaging

Undergo MRI

Andere Namen:
  • MRT
  • Magnetresonanz
  • Magnetresonanztomographie-Scan
  • Medizinische Bildgebung, Magnetresonanz / Kernspinresonanz
  • HERR
  • MR-Bildgebung
  • MRT-Untersuchung
  • NMR-Bildgebung
  • NMRI
  • Kernspinresonanztomographie
  • Magnetresonanztomographie (MRT)
  • sMRT
  • Magnetresonanztomographie (Verfahren)
  • MRTs
  • Strukturelle MRT
Sonstiges: Questionnaire Administration

Ancillary studies

Verfahren: Positron Emission Tomography

Undergo PET/CT

Andere Namen:
  • Medizinische Bildgebung, Positronen-Emissions-Tomographie
  • HAUSTIER
  • PET-Scan
  • Positronen-Emissions-Tomographie-Scan
  • Positronen-Emissions-Tomographie
  • Pt
  • Positronen-Emissions-Tomographie (Verfahren)
Strahlung: Intensity-Modulated Radiation Therapy

Undergo IMRT

Andere Namen:
  • IMRT
  • Intensitätsmodulierte RT
  • Intensitätsmodulierte Strahlentherapie
  • Bestrahlung, intensitätsmodulierte Strahlentherapie
  • Intensitätsmodulierte Strahlentherapie (Verfahren)
Verfahren: Computed Tomography

Undergo CT and/or PET/CT

Andere Namen:
  • CT
  • KATZE
  • Computertomographie
  • Computergestützte axiale Tomographie
  • CT-Scan
  • Tomographie
  • Computerisierte Axialtomographie (Verfahren)
  • Computertomographie (CT)-Scan
  • Diagnosekatze Scan
  • Diagnose -Katzen -Scan -Service -Typ
Verfahren: Biospecimen Collection

Undergo collection of blood and/or plasma

Andere Namen:
  • Biologische Probensammlung
  • Bioprobe gesammelt
  • Probenentnahme
  • Beispielsammlung
Strahlung: Image Guided Radiation Therapy

Undergo IGRT

Andere Namen:
  • IGRT
  • bildgeführte Strahlentherapie
  • Bildgeführte Strahlentherapie
Verfahren: Surgical Procedure

Undergo surgery per SOC

Andere Namen:
  • Betrieb
  • Chirurgie
  • Art der Operation
  • Chirurgisch
  • Operativer Eingriff
  • Chirurgische Eingriffe
  • Chirurgische Maßnahmen
  • Chirurgie, NOS
Verfahren: Surgical Procedure

Undergo response-adaptive surgery

Andere Namen:
  • Betrieb
  • Chirurgie
  • Art der Operation
  • Chirurgisch
  • Operativer Eingriff
  • Chirurgische Eingriffe
  • Chirurgische Maßnahmen
  • Chirurgie, NOS
Experimental: Arm 2 (cemiplimab, surgery, radiation)

Patients receive cemiplimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo response-adaptive surgery 21 days after last dose of cemiplimab. Starting within 12 weeks of surgery, patients may undergo IGRT with IMRT for 5 fractions per week for 6 weeks as clinically indicated. Starting within 6 weeks of completion of surgery or radiation therapy (if indicated), patients without pCR receive cemiplimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or PET/CT prior to treatment, and CT and/or MRI on study and during follow up. Patients may also undergo optional collection of tissue, whole blood, and plasma on study.
Verfahren: Magnetic Resonance Imaging

Undergo MRI

Andere Namen:
  • MRT
  • Magnetresonanz
  • Magnetresonanztomographie-Scan
  • Medizinische Bildgebung, Magnetresonanz / Kernspinresonanz
  • HERR
  • MR-Bildgebung
  • MRT-Untersuchung
  • NMR-Bildgebung
  • NMRI
  • Kernspinresonanztomographie
  • Magnetresonanztomographie (MRT)
  • sMRT
  • Magnetresonanztomographie (Verfahren)
  • MRTs
  • Strukturelle MRT
Sonstiges: Questionnaire Administration

Ancillary studies

Verfahren: Positron Emission Tomography

Undergo PET/CT

Andere Namen:
  • Medizinische Bildgebung, Positronen-Emissions-Tomographie
  • HAUSTIER
  • PET-Scan
  • Positronen-Emissions-Tomographie-Scan
  • Positronen-Emissions-Tomographie
  • Pt
  • Positronen-Emissions-Tomographie (Verfahren)
Strahlung: Intensity-Modulated Radiation Therapy

Undergo IMRT

Andere Namen:
  • IMRT
  • Intensitätsmodulierte RT
  • Intensitätsmodulierte Strahlentherapie
  • Bestrahlung, intensitätsmodulierte Strahlentherapie
  • Intensitätsmodulierte Strahlentherapie (Verfahren)
Biologisch: Cemiplimab

Given IV

Andere Namen:
  • REGN2810
  • Cemiplimab RWLC
  • Cemiplimab-rwlc
  • Libtayo
  • REGN 2810
  • REGN-2810
Verfahren: Computed Tomography

Undergo CT and/or PET/CT

Andere Namen:
  • CT
  • KATZE
  • Computertomographie
  • Computergestützte axiale Tomographie
  • CT-Scan
  • Tomographie
  • Computerisierte Axialtomographie (Verfahren)
  • Computertomographie (CT)-Scan
  • Diagnosekatze Scan
  • Diagnose -Katzen -Scan -Service -Typ
Verfahren: Biospecimen Collection

Undergo collection of blood and/or plasma

Andere Namen:
  • Biologische Probensammlung
  • Bioprobe gesammelt
  • Probenentnahme
  • Beispielsammlung
Strahlung: Image Guided Radiation Therapy

Undergo IGRT

Andere Namen:
  • IGRT
  • bildgeführte Strahlentherapie
  • Bildgeführte Strahlentherapie
Verfahren: Surgical Procedure

Undergo surgery per SOC

Andere Namen:
  • Betrieb
  • Chirurgie
  • Art der Operation
  • Chirurgisch
  • Operativer Eingriff
  • Chirurgische Eingriffe
  • Chirurgische Maßnahmen
  • Chirurgie, NOS
Verfahren: Surgical Procedure

Undergo response-adaptive surgery

Andere Namen:
  • Betrieb
  • Chirurgie
  • Art der Operation
  • Chirurgisch
  • Operativer Eingriff
  • Chirurgische Eingriffe
  • Chirurgische Maßnahmen
  • Chirurgie, NOS

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Event-free survival (EFS)
Zeitfenster: Up to 6 years

Defined as the time from randomization to any of the following events: progression of disease that precludes surgery, toxic effects related to treatment that preclude surgery, inability to resect all gross disease), disease recurrence (local, regional, or distant) after surgery (or after radiographic complete response), disease progression after radiographic partial response or stable disease without surgery (or biopsy, as applicable), or death due to any cause, whichever occurs first. EFS rates will be estimated using the Kaplan-Meier method, and the stratified log-rank test will be used to assess whether perioperative immunotherapy (neoadjuvant/adjuvant) with response-adapted oncologic surgery improves EFS as recorded by the site compared to standard-of-care surgery in resectable stage III/IV cutaneous squamous cell carcinoma (CSCC).
Up to 6 years

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Utilization of adjuvant radiation
Zeitfenster: Up to 6 years

Rates of utilization of adjuvant radiation for each arm will be computed using a binomial distribution assumption. A 95% confidence interval (CI) for the rate difference between arms will be calculated using the stratified Newcombe (Wilson) method (Yan 2010).
Up to 6 years
Disease-free survival (DFS)
Zeitfenster: From randomization to recurrent or death, assessed up to 6 years

DFS will use the same analytic methods as EFS.
From randomization to recurrent or death, assessed up to 6 years
Overall survival (OS)
Zeitfenster: From randomization to death, assessed up to 6 years

OS will use the same analytic methods as EFS.
From randomization to death, assessed up to 6 years
Incidence of adverse events
Zeitfenster: At 30 days and then up to 6 years

Adverse events (AEs) will be graded using Common Terminology Criteria for Adverse Events version (v) 5.0. Counts and frequencies of all AEs by grade will be provided by each treatment arm. For the experimental arm, AEs will be summarized for each treatment phase (neoadjuvant, adjuvant, and post-treatment [after adjuvant]). Counts and frequencies will be provided for the worst grade AE experienced by the patient by treatment arm. The proportion of patients with at least one grade 3 or higher AE, serious AEs, AEs leading to discontinuation or death will be reported for each treatment arm. These analyses will be descriptive.
At 30 days and then up to 6 years
Pathologic complete response
Zeitfenster: At 1 and 2 years

Site-reported pathologic response will be assessed using the following categories: pathological complete, major, and partial response, no pathological response (i.e., no complete, major, or partial response), and no pathological evaluation. Pathological responses at 1 and 2 years will be summarized using frequencies and percentages and tested using a chi-square test at a two-sided 5% significance level.
At 1 and 2 years

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Quality of life
Zeitfenster: From baseline up to 12 months after surgery

The primary patient-reported outcome (PRO) is the global health status score as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. For all PRO scheduled assessment visits, patient disposition will be summarized. PRO completion rate and available data rate will be computed and reported at each timepoint. Mixed effects model with repeated measures (MMRM) will be performed for the global health status score incorporating all PRO assessment timepoints. The adjusted means for each treatment and the estimated treatment differences for the treatment comparisons will be presented together with 95% CIs.
From baseline up to 12 months after surgery
Validation and scoring of Cutaneous Squamous Cell Carcinoma NeoAdjuvant, Adjuvant and Perioperative 32 question scale (CSCC NAAP-32)
Zeitfenster: From baseline up to 12 months after surgery

Item response distributions, inter-item correlations, factor analysis and internal consistency will be assessed. Confirmatory factor analyses will be used to confirm the underlying structure hypothesized by the conceptual framework. Items capturing perceptions and effect of treatments will be evaluated with single-item scores. Completion rate and available data rate will be computed and reported at each timepoint. CSCC-NAAP-32 item responses will be described at baseline to evaluate floor/ceiling effects, missingness, outliers, and multi-modal distributions. Internal consistency reliability for multi-item scales will be evaluated at baseline using both Cronbach's alpha and McDonald Omega coefficients. Test-retest reliability will be assessed using intraclass correlation coefficients between two time points. Construct validity and ability to detect change over time will be assessed.
From baseline up to 12 months after surgery
Change in patient-reported symptoms, functioning, and quality of life
Zeitfenster: From baseline up to 12 months after surgery

PRO instruments will be scored based on their respective scoring algorithms. Descriptive statistics, MMRMs, and assessment of missing data will be performed.
From baseline up to 12 months after surgery
Disease-specific survival (DSS)
Zeitfenster: From randomization to death due to study cancer, date of precluding event, or last follow up, assessed up to 6 years

The cause-specific log-rank test and cause-specific Cox models will also be used to compare cause-specific HRs between treatment arms and estimate cause-specific treatment-effect HRs, respectively. The cumulative incidence method will be used to estimate the incidence of cancer-specific mortality with between-arm differences tested using the stratified Gray's test. Stratified sub-distribution HR and 95% CI for treatment effect from Fine-Gray models will be computed to supplement the DSS analysis.
From randomization to death due to study cancer, date of precluding event, or last follow up, assessed up to 6 years
Pathologic response
Zeitfenster: Up to 6 years

Will evaluate the association of pathologic response with DFS in the experimental arm. Will compare EFS between patients with complete response versus others (major/partial/no response/not evaluable) using a log-rank test. DFS rates for each pathological response subgroup will be estimated using the Kaplan-Meier method. Furthermore, DFS rates for each pathological response subgroup will be calculated using the Kaplan-Meier method as an exploratory analysis.
Up to 6 years
Overall response rate
Zeitfenster: Up to 6 years

Will be assessed using Response Evaluation Criteria in Solid Tumors v. 1.1 and summarized by time-point using frequencies and relative frequencies. The best objective response (complete response + partial response) rate will be estimated using a 95% confidence interval obtained using the normal approximation for a binomial proportion.
Up to 6 years
Failure patterns
Zeitfenster: Up to 6 years

Failure patterns (local, regional, and distant metastasis) for EFS will be summarized for each treatment arm.
Up to 6 years
Lymph node yield
Zeitfenster: At time of surgery

The pathologic measurements of lymph node yield (i.e., number of lymph nodes) will be compared between arms using the Mann-Whitney test.
At time of surgery
Primary tumor specimen dimensions
Zeitfenster: At time of surgery

The pathologic measurements of the primary tumor specimens' length, width, and volume will be compared between arms using the t-test for independent samples. A Mann-Whitney test will be used if the distribution of a variable does not pass the normality test.
At time of surgery
Treatment effect HR estimates
Zeitfenster: Up to 6 years

Treatment effect HR estimates and 95% CIs for the primary and secondary endpoints (EFS, DFS, DSS, OS) will be calculated using a (cause-specific) Cox model with treatment by factor interaction for the following subgroups:

  • Immunosuppressed (Yes versus [vs.] no)
  • Advanced nodal disease (N3 or in-transit metastases vs. other).
  • Clinical Union for International Cancer Control or American Joint Committee on Cancer 8th Edition stage III vs. IV
  • Female vs. male
  • Age < 70 vs. ≥ 70 years
  • Eastern Cooperative Oncology Group performance status (0 vs. 1-2)
  • Females vs. males
  • White vs. other race
  • Head and neck vs. trunk/extremities
  • T stage (Tx-2 vs. > T2)
  • N stage (N0-1 vs. > N1)
  • Country A forest plot with these treatment effect HR estimates will be provided.
Up to 6 years
Treatment effect estimates by sex
Zeitfenster: Up to 6 years

Estimates of the primary outcome treatment effect and the corresponding 95% CIs by sex will be provided.
Up to 6 years
Treatment effect estimates by race
Zeitfenster: Up to 6 years

Estimates of the primary outcome treatment effect and the corresponding 95% CIs by race will be provided.
Up to 6 years
Treatment effect estimates by ethnicity
Zeitfenster: Up to 6 years

Estimates of the primary outcome treatment effect and the corresponding 95% CIs by ethnicity will be provided.
Up to 6 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National Cancer Institute (NCI)

Ermittler

  • Hauptermittler: Neil D Gross, NRG Oncology

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

18. Februar 2025

Primärer Abschluss (Geschätzt)

14. August 2031

Studienabschluss (Geschätzt)

14. August 2031

Studienanmeldedaten

Zuerst eingereicht

22. August 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. August 2024

Zuerst gepostet (Tatsächlich)

23. August 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NCI-2024-03425
  • U10CA180868 (US NIH Stipendium/Vertrag)
  • NCI-2024-03425 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
  • NRG-HN014 (Andere Kennung: CTEP)
  • NRG-HN014 (Andere Kennung: NRG Oncology)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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