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Testování přidání imunoterapeutického léku, cemiplimabu (REGN2810), plus chirurgie k obvyklé operaci samotné pro léčbu pokročilé rakoviny kůže

31. října 2026 aktualizováno: National Cancer Institute (NCI)

Randomizovaná studie fáze III perioperační imunoterapie s léčbou přizpůsobenou odpovědi versus standardní léčba u resekabilního kožního spinocelulárního karcinomu stadia 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.

Přehled studie

Postavení

Pozastaveno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

420

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.
Postup: Magnetic Resonance Imaging

Undergo MRI

Ostatní jména:
  • MRI
  • Magnetická rezonance
  • Skenování magnetickou rezonancí
  • Lékařské zobrazování, magnetická rezonance / nukleární magnetická rezonance
  • PAN
  • MR zobrazování
  • MRI skenování
  • NMR zobrazování
  • NMRI
  • Nukleární magnetická rezonance
  • Zobrazování magnetickou rezonancí (MRI)
  • sMRI
  • Magnetická rezonance (postup)
  • Strukturální MRI
Jiný: Questionnaire Administration

Ancillary studies

Postup: Positron Emission Tomography

Undergo PET/CT

Ostatní jména:
  • Lékařské zobrazování, pozitronová emisní tomografie
  • PET
  • PET skenování
  • Skenování pozitronové emisní tomografie
  • Pozitronová emisní tomografie
  • PT
  • Pozitronová emisní tomografie (postup)
Záření: Intensity-Modulated Radiation Therapy

Undergo IMRT

Ostatní jména:
  • IMRT
  • Intensity Modulated RT
  • Intenzivně modulovaná radioterapie
  • Radiace, Intensivně modulovaná radioterapie
  • Radiační terapie s modulovanou intenzitou (postup)
Postup: Computed Tomography

Undergo CT and/or PET/CT

Ostatní jména:
  • ČT
  • KOČKA
  • CAT skenování
  • Počítačová axiální tomografie
  • Počítačová tomografie
  • CT vyšetření
  • tomografie
  • Počítačová axiální tomografie (postup)
  • Počítačová tomografie (CT).
  • Diagnostické skenování CAT
  • Typ služby diagnostického skenování CAT
Postup: Biospecimen Collection

Undergo collection of blood and/or plasma

Ostatní jména:
  • Sběr biologických vzorků
  • Odebrán biovzorek
  • Sbírka vzorků
Záření: Image Guided Radiation Therapy

Undergo IGRT

Ostatní jména:
  • IGRT
  • radiační terapie řízená obrazem
  • Obrazem vedená radioterapie
  • Radioterapie vedená obrazem
Postup: Surgical Procedure

Undergo surgery per SOC

Ostatní jména:
  • Úkon
  • Chirurgická operace
  • Typ operace
  • Chirurgický
  • Chirurgická intervence
  • Chirurgické intervence
  • Chirurgické postupy
  • Typ chirurgie
  • Chirurgie, NOS
Postup: Surgical Procedure

Undergo response-adaptive surgery

Ostatní jména:
  • Úkon
  • Chirurgická operace
  • Typ operace
  • Chirurgický
  • Chirurgická intervence
  • Chirurgické intervence
  • Chirurgické postupy
  • Typ chirurgie
  • Chirurgie, NOS
Experimentální: 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.
Postup: Magnetic Resonance Imaging

Undergo MRI

Ostatní jména:
  • MRI
  • Magnetická rezonance
  • Skenování magnetickou rezonancí
  • Lékařské zobrazování, magnetická rezonance / nukleární magnetická rezonance
  • PAN
  • MR zobrazování
  • MRI skenování
  • NMR zobrazování
  • NMRI
  • Nukleární magnetická rezonance
  • Zobrazování magnetickou rezonancí (MRI)
  • sMRI
  • Magnetická rezonance (postup)
  • Strukturální MRI
Jiný: Questionnaire Administration

Ancillary studies

Postup: Positron Emission Tomography

Undergo PET/CT

Ostatní jména:
  • Lékařské zobrazování, pozitronová emisní tomografie
  • PET
  • PET skenování
  • Skenování pozitronové emisní tomografie
  • Pozitronová emisní tomografie
  • PT
  • Pozitronová emisní tomografie (postup)
Záření: Intensity-Modulated Radiation Therapy

Undergo IMRT

Ostatní jména:
  • IMRT
  • Intensity Modulated RT
  • Intenzivně modulovaná radioterapie
  • Radiace, Intensivně modulovaná radioterapie
  • Radiační terapie s modulovanou intenzitou (postup)
Biologický: Cemiplimab

Given IV

Ostatní jména:
  • REGN2810
  • Cemiplimab RWLC
  • Cemiplimab-rwlc
  • Libtayo
  • REGN 2810
  • REGN-2810
Postup: Computed Tomography

Undergo CT and/or PET/CT

Ostatní jména:
  • ČT
  • KOČKA
  • CAT skenování
  • Počítačová axiální tomografie
  • Počítačová tomografie
  • CT vyšetření
  • tomografie
  • Počítačová axiální tomografie (postup)
  • Počítačová tomografie (CT).
  • Diagnostické skenování CAT
  • Typ služby diagnostického skenování CAT
Postup: Biospecimen Collection

Undergo collection of blood and/or plasma

Ostatní jména:
  • Sběr biologických vzorků
  • Odebrán biovzorek
  • Sbírka vzorků
Záření: Image Guided Radiation Therapy

Undergo IGRT

Ostatní jména:
  • IGRT
  • radiační terapie řízená obrazem
  • Obrazem vedená radioterapie
  • Radioterapie vedená obrazem
Postup: Surgical Procedure

Undergo surgery per SOC

Ostatní jména:
  • Úkon
  • Chirurgická operace
  • Typ operace
  • Chirurgický
  • Chirurgická intervence
  • Chirurgické intervence
  • Chirurgické postupy
  • Typ chirurgie
  • Chirurgie, NOS
Postup: Surgical Procedure

Undergo response-adaptive surgery

Ostatní jména:
  • Úkon
  • Chirurgická operace
  • Typ operace
  • Chirurgický
  • Chirurgická intervence
  • Chirurgické intervence
  • Chirurgické postupy
  • Typ chirurgie
  • Chirurgie, NOS

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Event-free survival (EFS)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Utilization of adjuvant radiation
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Quality of life
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

National Cancer Institute (NCI)

Vyšetřovatelé

  • Vrchní vyšetřovatel: Neil D Gross, NRG Oncology

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

18. února 2025

Primární dokončení (Odhadovaný)

14. srpna 2031

Dokončení studie (Odhadovaný)

14. srpna 2031

Termíny zápisu do studia

První předloženo

22. srpna 2024

První předloženo, které splnilo kritéria kontroly kvality

22. srpna 2024

První zveřejněno (Aktuální)

23. srpna 2024

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

3. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

31. října 2026

Naposledy ověřeno

1. října 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • NCI-2024-03425
  • U10CA180868 (Grant/smlouva NIH USA)
  • NCI-2024-03425 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
  • NRG-HN014 (Jiný identifikátor: CTEP)
  • NRG-HN014 (Jiný identifikátor: NRG Oncology)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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