Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)
研究单位：[1]Merck Sharp & Dohme LLC[2]European Network for Gynaecological Oncological Trial Groups[3]Gynecologic Oncology Group[4]HonorHealth Research Institute - Biltmore ( Site 8009),Phoenix,Arizona,United States,85016[5]UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0027),Los Angeles,California,United States,90095[6]Hoag Memorial Hospital Presbyterian ( Site 0038),Newport Beach,California,United States,92663[7]UC Davis Comprehensive Cancer Center ( Site 0017),Sacramento,California,United States,95817[8]University of Colorado Health Sciences Center and Hospital ( Site 0028),Denver,Colorado,United States,80262[9]Smilow Cancer Center at Yale-New Haven ( Site 0023),New Haven,Connecticut,United States,06510[10]AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 0009),Orlando,Florida,United States,32804[11]Parkview Research Center at Parkview Regional Medical Center ( Site 0026),Fort Wayne,Indiana,United States,46845[12]University of Kentucky Markey Cancer Center ( Site 0015),Lexington,Kentucky,United States,40536[13]Our Lady of the Lake Regional Medical Center. ( Site 0031),Baton Rouge,Louisiana,United States,70817[14]Women's Cancer Care ( Site 0039),Covington,Louisiana,United States,70433[15]Karmanos Cancer Institute ( Site 0018),Detroit,Michigan,United States,48201[16]Minnesota Oncology Hematology, PA ( Site 8007),Minneapolis,Minnesota,United States,55404[17]University of New Mexico Comprehensive Cancer Center-Clinical Research Office ( Site 0019),Albuquerque,New Mexico,United States,87106[18]University of North Carolina at Chapel Hill ( Site 0025),Chapel Hill,North Carolina,United States,27514[19]Sanford Bismarck Medical Center ( Site 0046),Bismarck,North Dakota,United States,58501[20]The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C,Columbus,Ohio,United States,43210[21]Willamette Valley Cancer Institute and Research Center ( Site 8000),Eugene,Oregon,United States,97401[22]Legacy Good Samaritan Medical Center ( Site 0013),Portland,Oregon,United States,97210[23]Allegheny Health Network West Penn Hospital-Gynecologic Oncology ( Site 0030),Pittsburgh,Pennsylvania,United States,15244[24]Hollings Cancer Center ( Site 0007),Charleston,South Carolina,United States,29425[25]Sanford Gynecology Oncology ( Site 0003),Sioux Falls,South Dakota,United States,57104[26]Texas Oncology-Austin Central ( Site 8006),Austin,Texas,United States,78731[27]Texas Oncology-Fort Worth Cancer Center ( Site 8001),Fort Worth,Texas,United States,76104[28]Texas Oncology-San Antonio Medical Center ( Site 8002),San Antonio,Texas,United States,78240[29]Texas Oncology-The Woodlands ( Site 8003),The Woodlands,Texas,United States,77380[30]UVA Health System ( Site 0005),Charlottesville,Virginia,United States,22908[31]Virginia Commonwealth University ( Site 0024),Richmond,Virginia,United States,23219[32]Westmead Hospital ( Site 0973),Westmead,New South Wales,Australia,2145[33]Royal Brisbane and Women s Hospital ( Site 0972),Herston,Queensland,Australia,4029[34]Monash Health-Monash Medical Centre ( Site 0970),Clayton,Victoria,Australia,3168[35]Peter MacCallum Cancer Centre ( Site 0971),Melbourne,Victoria,Australia,3000[36]St John of God Subiaco Hospital ( Site 0969),Subiaco,Western Australia,Australia,6008[37]Medizinische Universitat Graz ( Site 0569),Graz,Steiermark,Austria,8036[38]Medizinische Universitat Innsbruck ( Site 0566),Innsbruck,Tirol,Austria,6020[39]Medizinische Universität Wien ( Site 0567),Vienna,Wien,Austria,1090[40]UZA University Hospital Antwerp ( Site 0351),Edegem,Antwerpen,Belgium,2650[41]GZA Sint Augustinus ( Site 0356),Wilrijk,Antwerpen,Belgium,2610[42]C.I.U. Hopital Ambroise Pare ( Site 0353),Mons,Hainaut,Belgium,7000[43]OLV Ziekenhuis ( Site 0352),Aalst,Oost-Vlaanderen,Belgium,9300[44]AZ St Lucas ( Site 0349),Gent,Oost-Vlaanderen,Belgium,9000[45]Sichuan Cancer Hospital ( Site 1018),Chengdu, Sichuan, China, 610041
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival. Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.
