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Testar tillägget av ett immunterapiläkemedel, Cemiplimab (REGN2810), plus kirurgi till den vanliga operationen ensam för behandling av avancerad hudcancer

31 oktober 2026 uppdaterad av: National Cancer Institute (NCI)

Randomiserad fas III-studie av perioperativ immunterapi med responsanpassad behandling kontra standardbehandling för resektabelt stadium III/IV kutant skivepitelcancer

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.

Studieöversikt

Status

Upphängd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

420

Fas

  • Fas 3

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Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv 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.
Procedur: Magnetic Resonance Imaging

Undergo MRI

Andra namn:
  • MRI
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medicinsk bildbehandling, magnetisk resonans / kärnmagnetisk resonans
  • HERR
  • MR-avbildning
  • MRI-skanning
  • NMR-avbildning
  • NMRI
  • Kärnmagnetisk resonanstomografi
  • Magnetisk resonanstomografi (MRT)
  • sMRI
  • Magnetisk resonanstomografi (förfarande)
  • Strukturell MRI
Övrig: Questionnaire Administration

Ancillary studies

Procedur: Positron Emission Tomography

Undergo PET/CT

Andra namn:
  • Medicinsk avbildning, Positron Emission Tomografi
  • SÄLLSKAPSDJUR
  • Djur Scan
  • Positron Emission Tomography Scan
  • Positronemissionstomografi
  • PT
  • Positronemissionstomografi (förfarande)
Strålning: Intensity-Modulated Radiation Therapy

Undergo IMRT

Andra namn:
  • IMRT
  • Intensitetsmodulerad RT
  • Intensitetsmodulerad strålbehandling
  • Strålning, intensitetsmodulerad strålbehandling
  • Intensitetsmodulerad strålbehandling (procedur)
Procedur: Computed Tomography

Undergo CT and/or PET/CT

Andra namn:
  • CT
  • KATT
  • Datortomografi
  • Beräknad axiell tomografi
  • Datoriserad axialtomografi
  • tomografi
  • Datoriserad axiell tomografi (förfarande)
  • Datortomografi (CT) skanning
  • Diagnostisk kattskanning
  • Diagnostisk kattskanningstjänsttyp
Procedur: Biospecimen Collection

Undergo collection of blood and/or plasma

Andra namn:
  • Biologisk provsamling
  • Bioprov insamlat
  • Provsamling
  • Provuppsamling
Strålning: Image Guided Radiation Therapy

Undergo IGRT

Andra namn:
  • IGRT
  • bildstyrd strålterapi
  • Bildstyrd strålbehandling
  • Bildguidad strålbehandling
Procedur: Surgical Procedure

Undergo surgery per SOC

Andra namn:
  • Drift
  • Kirurgi
  • Typ av operation
  • Kirurgisk
  • Kirurgiskt ingrepp
  • Kirurgiska ingrepp
  • Typ av kirurgi
  • Kirurgi, NOS
Procedur: Surgical Procedure

Undergo response-adaptive surgery

Andra namn:
  • Drift
  • Kirurgi
  • Typ av operation
  • Kirurgisk
  • Kirurgiskt ingrepp
  • Kirurgiska ingrepp
  • Typ av kirurgi
  • Kirurgi, NOS
Experimentell: 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.
Procedur: Magnetic Resonance Imaging

Undergo MRI

Andra namn:
  • MRI
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medicinsk bildbehandling, magnetisk resonans / kärnmagnetisk resonans
  • HERR
  • MR-avbildning
  • MRI-skanning
  • NMR-avbildning
  • NMRI
  • Kärnmagnetisk resonanstomografi
  • Magnetisk resonanstomografi (MRT)
  • sMRI
  • Magnetisk resonanstomografi (förfarande)
  • Strukturell MRI
Övrig: Questionnaire Administration

Ancillary studies

Procedur: Positron Emission Tomography

Undergo PET/CT

Andra namn:
  • Medicinsk avbildning, Positron Emission Tomografi
  • SÄLLSKAPSDJUR
  • Djur Scan
  • Positron Emission Tomography Scan
  • Positronemissionstomografi
  • PT
  • Positronemissionstomografi (förfarande)
Strålning: Intensity-Modulated Radiation Therapy

Undergo IMRT

Andra namn:
  • IMRT
  • Intensitetsmodulerad RT
  • Intensitetsmodulerad strålbehandling
  • Strålning, intensitetsmodulerad strålbehandling
  • Intensitetsmodulerad strålbehandling (procedur)
Biologisk: Cemiplimab

Given IV

Andra namn:
  • REGN2810
  • Cemiplimab RWLC
  • Cemiplimab-rwlc
  • Libtayo
  • REGN 2810
  • REGN-2810
Procedur: Computed Tomography

Undergo CT and/or PET/CT

Andra namn:
  • CT
  • KATT
  • Datortomografi
  • Beräknad axiell tomografi
  • Datoriserad axialtomografi
  • tomografi
  • Datoriserad axiell tomografi (förfarande)
  • Datortomografi (CT) skanning
  • Diagnostisk kattskanning
  • Diagnostisk kattskanningstjänsttyp
Procedur: Biospecimen Collection

Undergo collection of blood and/or plasma

Andra namn:
  • Biologisk provsamling
  • Bioprov insamlat
  • Provsamling
  • Provuppsamling
Strålning: Image Guided Radiation Therapy

Undergo IGRT

Andra namn:
  • IGRT
  • bildstyrd strålterapi
  • Bildstyrd strålbehandling
  • Bildguidad strålbehandling
Procedur: Surgical Procedure

Undergo surgery per SOC

Andra namn:
  • Drift
  • Kirurgi
  • Typ av operation
  • Kirurgisk
  • Kirurgiskt ingrepp
  • Kirurgiska ingrepp
  • Typ av kirurgi
  • Kirurgi, NOS
Procedur: Surgical Procedure

Undergo response-adaptive surgery

Andra namn:
  • Drift
  • Kirurgi
  • Typ av operation
  • Kirurgisk
  • Kirurgiskt ingrepp
  • Kirurgiska ingrepp
  • Typ av kirurgi
  • Kirurgi, NOS

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Event-free survival (EFS)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Utilization of adjuvant radiation
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Quality of life
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Cancer Institute (NCI)

Utredare

  • Huvudutredare: Neil D Gross, NRG Oncology

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

18 februari 2025

Primärt slutförande (Beräknad)

14 augusti 2031

Avslutad studie (Beräknad)

14 augusti 2031

Studieregistreringsdatum

Först inskickad

22 augusti 2024

Först inskickad som uppfyllde QC-kriterierna

22 augusti 2024

Första postat (Faktisk)

23 augusti 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NCI-2024-03425
  • U10CA180868 (U.S.S. NIH-anslag/kontrakt)
  • NCI-2024-03425 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • NRG-HN014 (Annan identifierare: CTEP)
  • NRG-HN014 (Annan identifierare: NRG Oncology)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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