Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
Official Title: A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18/ENGOT-cx11/GOG-3047)
Study ID: NCT04221945
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
HonorHealth Research Institute - Biltmore ( Site 8009), Phoenix, Arizona, United States
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0027), Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian ( Site 0038), Newport Beach, California, United States
UC Davis Comprehensive Cancer Center ( Site 0017), Sacramento, California, United States
University of Colorado Health Sciences Center and Hospital ( Site 0028), Denver, Colorado, United States
Smilow Cancer Center at Yale-New Haven ( Site 0023), New Haven, Connecticut, United States
AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 0009), Orlando, Florida, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0026), Fort Wayne, Indiana, United States
University of Kentucky Markey Cancer Center ( Site 0015), Lexington, Kentucky, United States
Our Lady of the Lake Regional Medical Center. ( Site 0031), Baton Rouge, Louisiana, United States
Women's Cancer Care ( Site 0039), Covington, Louisiana, United States
Karmanos Cancer Institute ( Site 0018), Detroit, Michigan, United States
Minnesota Oncology Hematology, PA ( Site 8007), Minneapolis, Minnesota, United States
University of New Mexico Comprehensive Cancer Center-Clinical Research Office ( Site 0019), Albuquerque, New Mexico, United States
University of North Carolina at Chapel Hill ( Site 0025), Chapel Hill, North Carolina, United States
Sanford Bismarck Medical Center ( Site 0046), Bismarck, North Dakota, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C, Columbus, Ohio, United States
Willamette Valley Cancer Institute and Research Center ( Site 8000), Eugene, Oregon, United States
Legacy Good Samaritan Medical Center ( Site 0013), Portland, Oregon, United States
Allegheny Health Network West Penn Hospital-Gynecologic Oncology ( Site 0030), Pittsburgh, Pennsylvania, United States
Hollings Cancer Center ( Site 0007), Charleston, South Carolina, United States
Sanford Gynecology Oncology ( Site 0003), Sioux Falls, South Dakota, United States
Texas Oncology-Austin Central ( Site 8006), Austin, Texas, United States
Texas Oncology-Fort Worth Cancer Center ( Site 8001), Fort Worth, Texas, United States
Texas Oncology-San Antonio Medical Center ( Site 8002), San Antonio, Texas, United States
Texas Oncology-The Woodlands ( Site 8003), The Woodlands, Texas, United States
UVA Health System ( Site 0005), Charlottesville, Virginia, United States
Virginia Commonwealth University ( Site 0024), Richmond, Virginia, United States
Westmead Hospital ( Site 0973), Westmead, New South Wales, Australia
Royal Brisbane and Women s Hospital ( Site 0972), Herston, Queensland, Australia
Monash Health-Monash Medical Centre ( Site 0970), Clayton, Victoria, Australia
Peter MacCallum Cancer Centre ( Site 0971), Melbourne, Victoria, Australia
St John of God Subiaco Hospital ( Site 0969), Subiaco, Western Australia, Australia
Medizinische Universitat Graz ( Site 0569), Graz, Steiermark, Austria
Medizinische Universitat Innsbruck ( Site 0566), Innsbruck, Tirol, Austria
Medizinische Universität Wien ( Site 0567), Vienna, Wien, Austria
UZA University Hospital Antwerp ( Site 0351), Edegem, Antwerpen, Belgium
GZA Sint Augustinus ( Site 0356), Wilrijk, Antwerpen, Belgium
C.I.U. Hopital Ambroise Pare ( Site 0353), Mons, Hainaut, Belgium
OLV Ziekenhuis ( Site 0352), Aalst, Oost-Vlaanderen, Belgium
AZ St Lucas ( Site 0349), Gent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0354), Leuven, Vlaams-Brabant, Belgium
Hospital das Clinicas da UFMG ( Site 0172), Belo Horizonte, Minas Gerais, Brazil
Liga Norte Riograndense Contra o Cancer ( Site 0170), Natal, Rio Grande Do Norte, Brazil
Hospital de Clínicas de Ribeirão Preto ( Site 0171), Ribeirão Preto, Sao Paulo, Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0166), São Paulo, Sao Paulo, Brazil
Instituto Nacional Do Cancer II ( Site 0173), Rio de Janeiro, , Brazil
Princess Margaret Cancer Centre ( Site 0102), Toronto, Ontario, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0101), Montreal, Quebec, Canada
McGill University Health Centre ( Site 0105), Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0, Quebec City, Quebec, Canada
Centro Investigación del Cáncer James Lind ( Site 0194), Temuco, Araucania, Chile
Sociedad Oncovida S.A. ( Site 0196), Santiago, Region M. De Santiago, Chile
Iram Cancer Research ( Site 0198), Santiago, Region M. De Santiago, Chile
Oncocentro ( Site 0195), Vina del Mar, Valparaiso, Chile
Anhui Provincial Hospital ( Site 1029), Hefei, Anhui, China
Anhui Provincial Cancer Hospital ( Site 1007), Hefei, Anhui, China
Peking Union Medical College Hospital ( Site 1001), Beijing, Beijing, China
Chongqing Cancer Hospital ( Site 1030), Chongqing, Chongqing, China
The First Affiliated Hospital of Xiamen University ( Site 1025), Xiamen, Fujian, China
The First Affiliated Hospital.Sun Yat-sen University ( Site 1005), Guangzhou, Guangdong, China
Affiliated Cancer Hospital of Guangxi Medical University ( Site 1036), Nanning, Guangxi, China
Harbin Medical University Cancer Hospital ( Site 1013), Harbin, Heilongjiang, China
Hunan Cancer Hospital ( Site 1015), Changsha, Hunan, China
Xiangya Hospital Central-South University ( Site 1009), Changsha, Hunan, China
Shanghai Cancer Hospital ( Site 1000), Shanghai, Shanghai, China
Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 1039), Shanghai, Shanghai, China
Sichuan Cancer Hospital ( Site 1018), Chengdu, Sichuan, China
The First Affiliated Hospital of Xinjiang Medical University ( Site 1012), Urumqi, Xinjiang, China
Zhejiang Provincial People's Hospital ( Site 1021), Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 1004), Hangzhou, Zhejiang, China
Fundacion Centro de Investigacion Clinica CIC ( Site 0231), Medellin, Antioquia, Colombia
Instituto Nacional de Cancerologia E.S.E ( Site 0228), Bogota, Distrito Capital De Bogota, Colombia
Fundacion Valle del Lili ( Site 0230), Cali, Valle Del Cauca, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0227), Cali, Valle Del Cauca, Colombia
Fakultni Nemocnice Brno Bohunice ( Site 0912), Brno, Brno-mesto, Czechia
Fakultni nemocnice Ostrava ( Site 0909), Ostrava, Moravskoslezsky Kraj, Czechia
Fakultni nemocnice Kralovske Vinohrady ( Site 0913), Praha 10, , Czechia
CHU Jean Minjoz ( Site 0411), Besancon, Doubs, France
Institut Claudius Regaud ( Site 0417), Toulouse, Haute-Garonne, France
Centre Hospitalier Lyon Sud ( Site 0413), Pierre Benite, Rhone, France
Universitaetsklinikum Freiburg ( Site 0454), Freiburg, Baden-Wurttemberg, Germany
Universitätsmedizin Mannheim-Department of Obstetrics and Gynecology ( Site 0443), Mannheim, Baden-Wurttemberg, Germany
Klinikum der Universitaet in Muenchen ( Site 0446), Muenchen, Bayern, Germany
Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0453), Muenchen, Bayern, Germany
Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 0452), Dresden, Sachsen, Germany
Universitaetsklinik Leipzig ( Site 0456), Leipzig, Sachsen, Germany
Charite Universitaetsmedizin Berlin ( Site 0442), Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0445), Hamburg, , Germany
General Hospital of Patras. St Andrews ( Site 0473), Patras, Achaia, Greece
Alexandra General Hospital ( Site 0477), Athens, Attiki, Greece
Hospital Hygeia ( Site 0478), Athens, Attiki, Greece
Euromedica General Clinic of Thessaloniki ( Site 0474), Thessaloniki, , Greece
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0321), Guatemala, , Guatemala
Oncologika S.A. ( Site 0323), Guatemala, , Guatemala
Oncomedica ( Site 0320), Guatemala, , Guatemala
Grupo Angeles SA ( Site 0319), Guatemala, , Guatemala
Medi-K Cayala ( Site 0318), Guatemala, , Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 0322), Quetzaltenango, , Guatemala
Orszagos Onkologiai Intezet ( Site 0846), Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 0845), Debrecen, , Hungary
Cork University Hospital ( Site 0504), Cork, , Ireland
St James Hospital ( Site 0505), Dublin, , Ireland
Rambam Medical Center ( Site 0815), Haifa, , Israel
Hadassah Medical Center. Ein Kerem ( Site 0816), Jerusalem, , Israel
Chaim Sheba Medical Center ( Site 0814), Ramat Gan, , Israel
Sourasky Medical Center ( Site 0819), Tel Aviv, , Israel
Istituto Europeo di Oncologia ( Site 0536), Milan, Milano, Italy
Istituto di Candiolo - IRCCS ( Site 0546), Candiolo, Piemonte, Italy
Istituto Nazionale Tumori Regina Elena ( Site 0540), Rome, Roma, Italy
A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 0541), Bologna, , Italy
Ospedale Vito Fazzi ( Site 0547), Lecce, , Italy
IRCCS Ospedale San Raffaele ( Site 0539), Milano, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0542), Milano, , Italy
Fondazione Giovanni Pascale Di Napoli ( Site 0544), Napoli, , Italy
Policlinico Universitario Gemelli ( Site 0538), Roma, , Italy
A.O.U. Citta della Salute e della Scienza di Torino ( Site 0535), Torino, , Italy
Aichi Cancer Center Hospital ( Site 1155), Nagoya, Aichi, Japan
National Cancer Center Hospital East ( Site 1159), Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center ( Site 1162), Matsuyama, Ehime, Japan
Ehime University Hospital ( Site 1157), Toon, Ehime, Japan
Kurume University Hospital ( Site 1164), Kurume, Fukuoka, Japan
Hokkaido University Hospital ( Site 1163), Sapporo, Hokkaido, Japan
Iwate Medical University Hospital ( Site 1165), Shiwa-gun, Iwate, Japan
University of the Ryukyus Hospital ( Site 1156), Nakagami-gun, Okinawa, Japan
Saitama Medical University International Medical Center ( Site 1168), Hidaka, Saitama, Japan
Saitama Cancer Center ( Site 1169), Kitaadachi-gun, Saitama, Japan
Kyorin University Hospital ( Site 1158), Mitaka, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center ( Site 1167), Fukuoka, , Japan
Kagoshima City Hospital ( Site 1166), Kagoshima, , Japan
Osaka International Cancer Institute ( Site 1161), Osaka, , Japan
National Cancer Center Hospital ( Site 1172), Tokyo, , Japan
Japanese Foundation for Cancer Research-Gynecologic Oncology ( Site 1171), Tokyo, , Japan
Keio University Hospital ( Site 1170), Tokyo, , Japan
National Cancer Center ( Site 1065), Goyang-si, Kyonggi-do, Korea, Republic of
Asan Medical Center ( Site 1062), Seoul., Seoul, Korea, Republic of
Keimyung University Dongsan Medical Center ( Site 1066), Daegu, Taegu-Kwangyokshi, Korea, Republic of
Severance Hospital ( Site 1063), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 1064), Seoul, , Korea, Republic of
Helse Bergen HF Haukeland Universitetssjukehus ( Site 0601), Bergen, Hordaland, Norway
Oslo Universitetssykehus Radiumhospitalet ( Site 0600), Oslo, , Norway
Centro Medico Monte Carmelo ( Site 0289), Arequipa, Ariqipa, Peru
Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 0287), Trujillo, La Libertad, Peru
Hospital Nacional Daniel Alcides Carrion ( Site 0293), Callao, Lima, Peru
Clinica San Gabriel ( Site 0296), San Miguel, Lima, Peru
Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 0290), Lima, , Peru
Hospital Nacional Arzobispo Loayza ( Site 0292), Lima, , Peru
Hospital Nacional Guillermo Almenara Irigoyen ( Site 0291), Lima, , Peru
Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 0741), Chelyabinsk, Chelyabinskaya Oblast, Russian Federation
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0729), Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation
MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 0722), Moscow, Moskva, Russian Federation
GBUZ SPb CRPCstmc(o) ( Site 0746), Saint Petersburg, Sankt-Peterburg, Russian Federation
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0725), St. Petersburg, Sankt-Peterburg, Russian Federation
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0734), Yaroslavl, Yaroslavskaya Oblast, Russian Federation
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0637), Badalona, Barcelona, Spain
Hosp Clin Univ de Santiago ( Site 0629), Santiago de Compostela, La Coruna, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 0638), Pozuelo de Alarcon, Madrid, Spain
Hospital Universitari Vall d Hebron ( Site 0634), Barcelona, , Spain
Complejo Hospitalario de Jaen ( Site 0632), Jaen, , Spain
Hospital Clinico Universitario Lozano Blesa ( Site 0630), Zaragoza, , Spain
Karolinska Universitetssjukhuset ( Site 0784), Stockholm, Stockholms Lan, Sweden
National Taiwan University Hospital ( Site 1095), Taipei, , Taiwan
Mackay Memorial Hospital ( Site 1094), Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital ( Site 1097), Taoyuan, , Taiwan
Srinagarind Hospital. Khon Kaen University ( Site 1132), Mueang, Khon Kaen, Thailand
Ramathibodi Hospital, Mahidol University ( Site 1131), Rajthevee, Krung Thep Maha Nakhon, Thailand
Songklanagarind Hospital ( Site 1130), Hatyai, Songkhla, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 1133), Chiang Mai, , Thailand
I.U. Cerrahpasa Medical Faculty ( Site 0755), Istambul, Istanbul, Turkey
Acibadem Adana Hastanesi ( Site 0756), Adana, , Turkey
Baskent Universitesi Ankara Hastanesi ( Site 0754), Ankara, , Turkey
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0876), Kharkiv, Kharkivska Oblast, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0882), Lviv, Lvivska Oblast, Ukraine
Royal Devon and Exeter Foundation Trust Hospital ( Site 0699), Exeter, England, United Kingdom
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0701), London, London, City Of, United Kingdom
Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 0696), London, Surrey, United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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