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진행성 피부암 치료를 위한 일반 수술 단독에 면역치료제 세미플리맙(REGN2810) + 수술 추가 테스트

2026년 10월 31일 업데이트: National Cancer Institute (NCI)

절제 가능한 III/IV기 피부 편평 세포 암종에 대한 반응 적응 치료와 표준 치료를 이용한 수술 전후 면역요법의 무작위 제3상 시험

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.

연구 개요

상태

정지된

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

420

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

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공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
절차: Magnetic Resonance Imaging

Undergo MRI

다른 이름들:
  • MRI
  • 자기 공명
  • 자기공명영상 스캔
  • 의료영상, 자기공명 / 핵자기공명
  • 씨
  • MR 이미징
  • MRI 검사
  • NMR 이미징
  • NMRI
  • 핵자기공명영상
  • 자기공명영상(MRI)
  • SMRI
  • 자기공명영상(시술)
  • 구조적 MRI
다른: Questionnaire Administration

Ancillary studies

절차: Positron Emission Tomography

Undergo PET/CT

다른 이름들:
  • 의료 영상, 양전자 방출 단층 촬영
  • 애완 동물
  • PET 스캔
  • 양전자 방출 단층 촬영 스캔
  • 양전자 방출 단층 촬영
  • PT
  • 양전자방출단층촬영(시술)
방사능: Intensity-Modulated Radiation Therapy

Undergo IMRT

다른 이름들:
  • IMRT
  • 강도 변조 RT
  • 강도 변조 방사선 요법
  • 방사선, 강도 변조 방사선 요법
  • 강도 조절 방사선 요법(시술)
절차: Computed Tomography

Undergo CT and/or PET/CT

다른 이름들:
  • CT
  • 고양이
  • 고양이 스캔
  • 컴퓨터 축 단층 촬영
  • 전산화 단층 촬영
  • CT 스캔
  • 단층 촬영
  • 컴퓨터 축 단층 촬영(시술)
  • 컴퓨터 단층촬영(CT) 스캔
  • 진단 CAT 스캔
  • 진단 CAT 스캔 서비스 유형
절차: Biospecimen Collection

Undergo collection of blood and/or plasma

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
방사능: Image Guided Radiation Therapy

Undergo IGRT

다른 이름들:
  • IGRT
  • 영상 유도 방사선 치료
  • 이미지 유도 방사선 요법
  • 이미지 안내 방사선 요법
절차: Surgical Procedure

Undergo surgery per SOC

다른 이름들:
  • 작업
  • 수술
  • 수술 종류
  • 외과
  • 외과 개입
  • 수술 절차
  • 수술의 종류
  • 수술, NOS
절차: Surgical Procedure

Undergo response-adaptive surgery

다른 이름들:
  • 작업
  • 수술
  • 수술 종류
  • 외과
  • 외과 개입
  • 수술 절차
  • 수술의 종류
  • 수술, NOS
실험적: 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.
절차: Magnetic Resonance Imaging

Undergo MRI

다른 이름들:
  • MRI
  • 자기 공명
  • 자기공명영상 스캔
  • 의료영상, 자기공명 / 핵자기공명
  • 씨
  • MR 이미징
  • MRI 검사
  • NMR 이미징
  • NMRI
  • 핵자기공명영상
  • 자기공명영상(MRI)
  • SMRI
  • 자기공명영상(시술)
  • 구조적 MRI
다른: Questionnaire Administration

Ancillary studies

절차: Positron Emission Tomography

Undergo PET/CT

다른 이름들:
  • 의료 영상, 양전자 방출 단층 촬영
  • 애완 동물
  • PET 스캔
  • 양전자 방출 단층 촬영 스캔
  • 양전자 방출 단층 촬영
  • PT
  • 양전자방출단층촬영(시술)
방사능: Intensity-Modulated Radiation Therapy

Undergo IMRT

다른 이름들:
  • IMRT
  • 강도 변조 RT
  • 강도 변조 방사선 요법
  • 방사선, 강도 변조 방사선 요법
  • 강도 조절 방사선 요법(시술)
생물학적: Cemiplimab

Given IV

다른 이름들:
  • REGN2810
  • 세미플리맙 RWLC
  • 세미플리맙-rwlc
  • 리브타요
  • REGN 2810
  • REGN-2810
절차: Computed Tomography

Undergo CT and/or PET/CT

다른 이름들:
  • CT
  • 고양이
  • 고양이 스캔
  • 컴퓨터 축 단층 촬영
  • 전산화 단층 촬영
  • CT 스캔
  • 단층 촬영
  • 컴퓨터 축 단층 촬영(시술)
  • 컴퓨터 단층촬영(CT) 스캔
  • 진단 CAT 스캔
  • 진단 CAT 스캔 서비스 유형
절차: Biospecimen Collection

Undergo collection of blood and/or plasma

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
방사능: Image Guided Radiation Therapy

Undergo IGRT

다른 이름들:
  • IGRT
  • 영상 유도 방사선 치료
  • 이미지 유도 방사선 요법
  • 이미지 안내 방사선 요법
절차: Surgical Procedure

Undergo surgery per SOC

다른 이름들:
  • 작업
  • 수술
  • 수술 종류
  • 외과
  • 외과 개입
  • 수술 절차
  • 수술의 종류
  • 수술, NOS
절차: Surgical Procedure

Undergo response-adaptive surgery

다른 이름들:
  • 작업
  • 수술
  • 수술 종류
  • 외과
  • 외과 개입
  • 수술 절차
  • 수술의 종류
  • 수술, NOS

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Event-free survival (EFS)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Utilization of adjuvant radiation
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Quality of life
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Cancer Institute (NCI)

수사관

  • 수석 연구원: Neil D Gross, NRG Oncology

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 2월 18일

기본 완료 (추정된)

2031년 8월 14일

연구 완료 (추정된)

2031년 8월 14일

연구 등록 날짜

최초 제출

2024년 8월 22일

QC 기준을 충족하는 최초 제출

2024년 8월 22일

처음 게시됨 (실제)

2024년 8월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 31일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NCI-2024-03425
  • U10CA180868 (미국 NIH 보조금/계약)
  • NCI-2024-03425 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
  • NRG-HN014 (기타 식별자: CTEP)
  • NRG-HN014 (기타 식별자: NRG Oncology)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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