Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.

Study Overview

• Status: Active, not recruiting
• Conditions: Endometrial Neoplasms
• Intervention / Treatment: Biological: Pembrolizumab; Drug: Paclitaxel; Drug: Carboplatin; Drug: Placebo for pembrolizumab; Drug: Docetaxel; Drug: Cisplatin; Radiation: External Beam Radiotherapy (EBRT); Drug: Cisplatin (as radiosensitizer); Radiation: Brachytherapy

• Study Type: Interventional
• Enrollment (Estimated): 990
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1012AAR
    • IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 1010)
  • Buenos Aires, Argentina, C1118AAT
    • Hospital Aleman ( Site 1001)
  • Buenos Aires, Argentina, C1431FWO
    • CEMIC ( Site 1009)
  • La Rioja, Argentina, F5300COE
    • Centro Oncologico Riojano Integral ( Site 1007)
  • Buenos Aires
    • Berazategui, Buenos Aires, Argentina, B1884BBF
      • Centro de Oncología e Investigación de Buenos Aires ( Site 1005)
    • Caba, Buenos Aires, Argentina, C1012AAR
      • IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 1006)
    • Mar del Plata, Buenos Aires, Argentina, B7600FZO
      • Instituto de Investigaciones Clinicas Mar del Plata ( Site 1003)
  • Caba
    • Buenos Aires, Caba, Argentina, C1280AEB
      • Hospital Britanico de Buenos Aires ( Site 1002)
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000KZE
      • Instituto de Oncologia de Rosario ( Site 1004)
• Austria
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Medizinische Universitat Graz ( Site 2004)
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Medizinische Universitaet Innsbruck ( Site 2001)
• Belgium
  • Liege, Belgium, 4000
    • CHC - Groupe Sante ( Site 2041)
  • Liege, Belgium, 4000
    • CHU Liege Sart-Tilman ( Site 2044)
  • Bruxelles-Capitale, Region De
    • Bruxelles, Bruxelles-Capitale, Region De, Belgium, 1200
      • Saint-Luc UCL ( Site 2042)
  • Hainaut
    • Mons, Hainaut, Belgium, 7000
      • C.I.U. Hopital Ambroise Pare ( Site 2039)
  • Liege
    • Verviers, Liege, Belgium, 4800
      • CHR Verviers ( Site 2035)
  • Oost-Vlaanderen
    • Aalst, Oost-Vlaanderen, Belgium, 9300
      • OLV Ziekenhuis ( Site 2038)
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • AZ Maria Middelares Gent ( Site 2032)
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • Universitair Ziekenhuis Gent ( Site 2037)
    • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
      • AZ Nikolaas ( Site 2031)
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • UZ Leuven ( Site 2040)
  • West-Vlaanderen
    • Kortrijk, West-Vlaanderen, Belgium, 8500
      • AZ Groeninge ( Site 2036)
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre ( Site 3007)
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston Health Sciences Centre ( Site 3003)
  • Quebec
    • Montreal, Quebec, Canada, H2X 0C1
      • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 3006)
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre ( Site 3005)
    • Quebec City, Quebec, Canada, G1J 1Z4
      • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 3
• Chile
  • Araucania
    • Temuco, Araucania, Chile, 4800827
      • Centro Investigación del Cáncer James Lind ( Site 1061)
  • Region M. De Santiago
    • Santiago, Region M. De Santiago, Chile, 7500921
      • Fundacion Arturo Lopez Perez FALP ( Site 1062)
    • Santiago, Region M. De Santiago, Chile, 8330032
      • Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063)
    • Santiago, Region M. De Santiago, Chile, 8420383
      • Bradfordhill-Clinical Area ( Site 1070)
  • Valparaiso
    • Vina del Mar, Valparaiso, Chile
      • Oncocentro ( Site 1065)
• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 4034)
  • Beijing
    • Beijing, Beijing, China, 100036
      • Beijing Cancer Hospital ( Site 4048)
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital ( Site 4036)
  • Chongqing
    • Chongqing, Chongqing, China, 400030
      • Chongqing Cancer Hospital ( Site 4040)
  • Fujian
    • Xiamen, Fujian, China, 361003
      • The First Affiliated Hospital of Xiamen University ( Site 4060)
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital ( Site 4043)
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Guangxi Medical University Affiliated Tumor Hospital ( Site 4049)
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital ( Site 4033)
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital ( Site 4059)
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central-South University ( Site 4035)
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital ( Site 4050)
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital ( Site 4037)
  • Jiangxi
    • Nanchang, Jiangxi, China, 530021
      • Jiangxi Maternal and Child Health Hospital ( Site 4051)
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Bethune Hospital of Jilin University ( Site 4057)
  • Shaanxi
    • XI An, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi an Jiaotong University ( Site 4045)
  • Shanghai
    • Shanghai, Shanghai, China, 200090
      • Obstetrics and Gynecology Hosp. Fudan University ( Site 4041)
    • Shanghai, Shanghai, China, 200127
      • Shanghai Renji Hospital Affiliated to Jiao Tong University ( Site 4053)
    • Shanghai, Shanghai, China, 201204
      • Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 4001)
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Sichuan Cancer Hospital ( Site 4039)
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute & Hospital ( Site 4054)
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Yunnan Province Cancer Hospital-Gynecology Department ( Site 4055)
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University-Gynecology ( Site 4002)
    • Hangzhou, Zhejiang, China, 310006
      • Women s Hospital School of Medicine Zhejiang University ( Site 4032)
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University ( Site 4056)
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 050030
      • Clínica Vida Fundación - Sede Poblado ( Site 1096)
  • Distrito Capital De Bogota
    • Bogota, Distrito Capital De Bogota, Colombia, 111511
      • Instituto Nacional de Cancerología E.S.E ( Site 1094)
  • Narino
    • San Juan De Pasto, Narino, Colombia, 520002
      • Instituto Cancerologico de Narino Ltda ( Site 1092)
  • Valle Del Cauca
    • Cali, Valle Del Cauca, Colombia, 760032
      • Fundacion Valle del Lili ( Site 1093)
• Czechia
  • Olomouc, Czechia, 775 20
    • Fakultni nemocnice Olomouc ( Site 2392)
  • Brno-mesto
    • Brno, Brno-mesto, Czechia, 62500
      • Fakultní nemocnice Brno Bohunice-Gynekologicko-porodnicka klinika ( Site 2394)
  • Praha 10
    • Praha, Praha 10, Czechia, 100 34
      • Fakultni nemocnice Kralovske Vinohrady ( Site 2393)
  • Praha 2
    • Praha, Praha 2, Czechia, 120 00
      • Vseobecna fakultni nemocnice v Praze ( Site 2391)
• Denmark
  • Hovedstaden
    • Copehagen, Hovedstaden, Denmark, 2100
      • Rigshospitalet University Hospital ( Site 2515)
    • Herlev, Hovedstaden, Denmark, 2730
      • Herlev Hospital ( Site 2514)
  • Nordjylland
    • Aalborg, Nordjylland, Denmark, 9100
      • Aalborg Universitetshospital ( Site 2511)
  • Sjaelland
    • Roskilde, Sjaelland, Denmark, 4000
      • Roskilde Sygehus ( Site 2513)
  • Syddanmark
    • Odense, Syddanmark, Denmark, 5000
      • Odense Universitetshospital ( Site 2512)
• Finland
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33520
      • Tampere University Hospital ( Site 2541)
  • Pohjois-Savo
    • Kuopio, Pohjois-Savo, Finland, 70029
      • Kuopio University Hospital ( Site 2543)
  • Varsinais-Suomi
    • Turku, Varsinais-Suomi, Finland, 20760
      • Turku University Hospital ( Site 2542)
• France
  • Ain
    • Vandoeuvre les Nancy, Ain, France, 54519
      • Institut De Cancerologie De Lorraine ( Site 2072)
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06189
      • Centre Antoine Lacassagne ( Site 2073)
  • Calvados
    • Caen, Calvados, France, 14076
      • Centre Francois Baclesse ( Site 2062)
  • Cotes-d Armor
    • Plérin, Cotes-d Armor, France, 22190
      • Hôpital Privé Des Côtes d'Armor ( Site 2063)
  • Doubs
    • Besancon, Doubs, France, 25000
      • CHU Besancon - Hopital Jean Minjoz ( Site 2068)
  • Gironde
    • Bordeaux, Gironde, France, 33076
      • Institut Bergonie ( Site 2067)
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31059
      • Institut Universitaire du Cancer Toulouse - Oncopole ( Site 2065)
  • Herault
    • Montpellier, Herault, France, 34298
      • Institut Regional du Cancer de Montpellier - ICM ( Site 2069)
  • Ile-de-France
    • Paris, Ile-de-France, France, 75014
      • Hopital Cochin ( Site 2070)
    • Villejuif, Ile-de-France, France, 94800
      • Gustave Roussy ( Site 2071)
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44277
      • Hopital prive du Confluent ( Site 2061)
  • Rhone
    • Pierre Benite, Rhone, France, 69310
      • Centre Hospitalier Lyon Sud ( Site 2064)
• Germany
  • Baden-Wurttemberg
    • Heilbronn, Baden-Wurttemberg, Germany, 74078
      • SLK-Kliniken Heilbronn GmbH ( Site 2116)
    • Ludwigsburg, Baden-Wurttemberg, Germany, 71640
      • Klinikum Ludwigsburg ( Site 2111)
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen ( Site 2113)
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Medizinische Hochschule Hannover-Department of Obstetrics and Gynecology ( Site 2109)
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53127
      • Universitätsklinikum Bonn-Gynaecological oncology ( Site 2103)
    • Essen, Nordrhein-Westfalen, Germany, 45136
      • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 2105)
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Universitätsklinikum Schleswig-Holstein ( Site 2101)
• Greece
  • Thessaloniki, Greece, 546 45
    • Euromedica General Clinic of Thessaloniki ( Site 2422)
  • Achaia
    • Patras, Achaia, Greece, 263 32
      • General Hospital of Patras. St Andrews ( Site 2421)
  • Attiki
    • Athens, Attiki, Greece, 115 28
      • Geniko Panepistimako Nosokomeio ARETEIO ( Site 2423)
    • Athens, Attiki, Greece, 115 28
      • Perifereiako Geniko Nosokomeio ALEXANDRA ( Site 2425)
    • Chaidari, Attiki, Greece, 124 62
      • Athens University Hospital ATTIKON ( Site 2424)
    • Marousi, Attiki, Greece, 151 23
      • Hospital Hygeia ( Site 2426)
• Israel
  • Haifa, Israel, 3109601
    • Rambam Medical Center ( Site 2307)
  • Holon, Israel, 5822012
    • Edith Wolfson Medical Center ( Site 2306)
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center. Ein Kerem ( Site 2303)
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center ( Site 2305)
  • Ramat Gan, Israel, 5262000
    • Chaim Sheba Medical Center ( Site 2301)
• Italy
  • Brescia, Italy, 25123
    • Azienda Ospedaliera Spedali Civili di Brescia ( Site 2135)
  • Milano, Italy, 20132
    • IRCCS Ospedale San Raffaele ( Site 2130)
  • Milano, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2122)
  • Milano, Italy, 20141
    • Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 2132)
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Universitaria Federico II ( Site 2123)
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2127)
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto IRCCS-Oncologia 2 ( Site 2134)
  • Abruzzo
    • Roma, Abruzzo, Italy, 00144
      • Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 2121)
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli ( Site 2124)
  • Piemonte
    • Candiolo, Piemonte, Italy, 10060
      • Istituto di Candiolo - IRCCS ( Site 2125)
• Japan
  • Fukuoka, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center ( Site 4193)
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital ( Site 4185)
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute ( Site 4188)
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital of JFCR ( Site 4196)
  • Tokyo, Japan, 160-8582
    • Keio University Hospital ( Site 4191)
  • Aichi
    • Nagoya, Aichi, Japan, 464-8681
      • Aichi Cancer Center Hospital ( Site 4190)
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East ( Site 4197)
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • National Hospital Organization Shikoku Cancer Center ( Site 4181)
    • Toon, Ehime, Japan, 7910295
      • Ehime University Hospital ( Site 4187)
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Kurume University Hospital ( Site 4186)
  • Gunma
    • Ota, Gunma, Japan, 373-8550
      • Gunma Prefectural Cancer Center ( Site 4183)
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital ( Site 4194)
  • Hyogo
    • Akashi, Hyogo, Japan, 673-8558
      • Hyogo Cancer Center ( Site 4195)
  • Iwate
    • Shiwa-gun, Iwate, Japan, 028-3695
      • Iwate Medical University Hospital ( Site 4189)
  • Okinawa
    • Nakagami-gun, Okinawa, Japan, 903-0215
      • University of the Ryukyus Hospital ( Site 4184)
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Saitama Medical University International Medical Center ( Site 4182)
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center Hospital and Research Institute ( Site 4192)
• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital Yonsei University Health System ( Site 4062)
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center ( Site 4061)
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center ( Site 4064)
  • Kyonggi-do
    • Goyang-si, Kyonggi-do, Korea, Republic of, 10408
      • National Cancer Center ( Site 4065)
    • Seongnam-si, Kyonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital ( Site 4063)
• Mexico
  • Ciudad de Mexico, Mexico, 06700
    • Hospital Angeles Roma ( Site 1123)
  • Mexico City, Mexico, 04700
    • Centro Oncologico Internacional. SEDNA ( Site 1121)
  • Baja California Sur
    • La Paz, Baja California Sur, Mexico, 23040
      • Investigacion Onco Farmaceutica S de RL de CV ( Site 1127)
  • Chiapas
    • Tuxtla Gutierrez, Chiapas, Mexico, 29090
      • Hospital San Lucas Cardiologica del Sureste ( Site 1122)
  • Distrito Federal
    • Cdmx, Distrito Federal, Mexico, 14080
      • Instituto Nacional de Cancerologia ( Site 1124)
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64570
      • Christus Muguerza Clinica Vidriera ( Site 1125)
    • Monterrey, Nuevo Leon, Mexico, 64710
      • I Can Oncology Center SA de CV ( Site 1126)
• Norway
  • Oslo, Norway, 0379
    • Oslo Universitetssykehus Radiumhospitalet ( Site 2151)
  • Troms
    • Tromso, Troms, Norway, 9019
      • University Hospital of North Norway ( Site 2153)
  • Vest-Agder
    • Kristiansand, Vest-Agder, Norway, 4615
      • Soerlandet sykehus HF Kristiansand ( Site 2152)
• Poland
  • Mazowieckie
    • Siedlce, Mazowieckie, Poland, 08-110
      • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2487)
    • Warszawa, Mazowieckie, Poland, 00-315
      • Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2481)
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-027
      • Bialostockie Centrum Onkologii ( Site 2483)
  • Slaskie
    • Gliwice, Slaskie, Poland, 44101
      • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2482)
  • Swietokrzyskie
    • Kielce, Swietokrzyskie, Poland, 25-734
      • Swietokrzyskie Centrum Onkologii SPZOZ ( Site 2485)
  • Warminsko-mazurskie
    • Olsztyn, Warminsko-mazurskie, Poland, 10-228
      • SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2486)
  • Wielkopolskie
    • Poznan, Wielkopolskie, Poland, 61-866
      • Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 2484)
• Russian Federation
  • Arkhangel Skaya Oblast
    • Arkhangelsk, Arkhangel Skaya Oblast, Russian Federation, 163045
      • Arkhangelsk Clinical Oncological Dispensary ( Site 2637)
  • Baskortostan, Respublika
    • Ufa, Baskortostan, Respublika, Russian Federation, 450054
      • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 2645)
  • Chelyabinskaya Oblast
    • Chelyabinsk, Chelyabinskaya Oblast, Russian Federation, 454087
      • Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 2644)
  • Krasnoyarskiy Kray
    • Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation, 660133
      • Krasnoyarsk Regional Clinical oncology dispensary ( Site 2643)
  • Mordoviya, Respublika
    • Saransk, Mordoviya, Respublika, Russian Federation, 430032
      • National Research Ogarev Mordovia State University ( Site 2648)
  • Moskva
    • Moscow, Moskva, Russian Federation, 115478
      • FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 2634)
    • Moscow, Moskva, Russian Federation, 125284
      • Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2631)
  • Nizhegorodskaya Oblast
    • Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603126
      • Nizhegorodsky Regional Oncology Dispensary-chemotherapy department (Branch№1) ( Site 2639)
  • Samarskaya Oblast
    • Samara, Samarskaya Oblast, Russian Federation, 443031
      • Samara Regional Clinical Oncology Center-Chemotherapy Dapartment ( Site 2649)
  • Sankt-Peterburg
    • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 197758
      • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2636)
  • Tatarstan, Respublika
    • Kazan, Tatarstan, Respublika, Russian Federation, 420029
      • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2646)
  • Tomskaya Oblast
    • Tomsk, Tomskaya Oblast, Russian Federation, 634028
      • Tomsk Scientific Research Institute of Oncology-Chemotherapy ( Site 2638)
  • Yaroslavskaya Oblast
    • Yaroslavl, Yaroslavskaya Oblast, Russian Federation, 150054
      • Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2641)
• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall D Hebron ( Site 2182)
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial ( Site 2185)
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia ( Site 2183)
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos ( Site 2187)
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz ( Site 2186)
  • Gerona
    • Girona, Gerona, Spain, 17007
      • Hospital Josep Trueta ( Site 2184)
  • Madrid, Comunidad De
    • Madrid, Madrid, Comunidad De, Spain, 28027
      • Clinica Universitaria de Navarra ( Site 2181)
• Sweden
  • Ostergotlands Lan
    • Linkoping, Ostergotlands Lan, Sweden, 581 85
      • Universitetssjukhuset i Linkoping. ( Site 2222)
  • Stockholms Lan
    • Solna, Stockholms Lan, Sweden, 171 76
      • Karolinska Universitetssjukhuset Solna ( Site 2220)
  • Uppsala Lan
    • Uppsala, Uppsala Lan, Sweden, 751 85
      • Blod-och Tumorsjukdomar ( Site 2221)
• Taiwan
  • Changhua, Taiwan, 50006
    • Changhua Christian Hospital ( Site 4095)
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital ( Site 4094)
  • Taipei, Taiwan, 10449
    • MacKay Memorial Hospital ( Site 4092)
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital ( Site 4093)
  • Taoyuan, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital ( Site 4091)
• Turkey
  • Adana, Turkey, 01250
    • Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2355)
  • Adana, Turkey, 01330
    • Cukurova Uni. Tip Fakultesi ( Site 2353)
  • Ankara, Turkey, 06490
    • Baskent Universitesi Ankara Hastanesi ( Site 2354)
  • Ankara, Turkey, 06590
    • Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 2350)
  • Istanbul, Turkey, 34214
    • Medipol Universite Hastanesi ( Site 2352)
  • Izmir, Turkey, 35100
    • Ege University Medical Faculty ( Site 2351)
  • Izmir, Turkey, 35575
    • I.E.U. Medical Point Hastanesi ( Site 2356)
• Ukraine
  • Chernihivska Oblast
    • Chernihiv, Chernihivska Oblast, Ukraine, 14029
      • Chernihiv Medical Center of Modern Oncology ( Site 2368)
  • Chernivetska Oblast
    • Chernivtsi, Chernivetska Oblast, Ukraine, 58000
      • Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 2366)
  • Kharkivska Oblast
    • Kharkiv, Kharkivska Oblast, Ukraine, 61024
      • SO Grigoriev Institute for Medical Radiology and Oncology of NAMS of Ukraine ( Site 2363)
  • Khmelnytska Oblast
    • Khmelnitskyi, Khmelnytska Oblast, Ukraine, 29009
      • MNE "Khmelnytskyi regional antitumor center" ( Site 2365)
  • Kyivska Oblast
    • Kiev, Kyivska Oblast, Ukraine, 08720
      • LISOD - Israeli Oncological Hospital MedX-ray International Group, LLC ( Site 2364)
  • Lvivska Oblast
    • Lviv, Lvivska Oblast, Ukraine, 79031
      • Lviv State Regional Oncological Center ( Site 2361)
  • Volynska Oblast
    • Lutsk, Volynska Oblast, Ukraine, 43018
      • The Municipal Enterprise Volyn Regional Medical Oncology Centre ( Site 2362)
• United Kingdom
  • Leicester, United Kingdom
    • Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 2249)
  • Manchester, United Kingdom, M20 4BX
    • The Christie Hospital NHS Foundation Trust ( Site 2243)
  • Bristol, City Of
    • Bristol, Bristol, City Of, United Kingdom, BS2 8ED
      • Bristol Haematology and Oncology Centre ( Site 2244)
  • East Riding Of Yorkshire
    • Cottingham, East Riding Of Yorkshire, United Kingdom, HU165JQ
      • Castle Hill Hospital-Academic Oncology ( Site 2252)
  • Glasgow City
    • Glasgow, Glasgow City, United Kingdom, G12 0YN
      • Beatson West of Scotland Cancer Centre ( Site 2247)
  • London, City Of
    • London, London, City Of, United Kingdom, NW1 2PG
      • UCLH NHS Foundation Trust ( Site 2242)
    • London, London, City Of, United Kingdom, SW3 6JJ
      • Royal Marsden NHS Foundation Trust ( Site 2248)
    • Sutton, London, City Of, United Kingdom, SM25PT
      • Royal Marsden Hospital Sutton-Surrey ( Site 2241)
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama - Birmingham ( Site 3061)
    • Mobile, Alabama, United States, 36604
      • University of South Alabama, Mitchell Cancer Institute ( Site 3058)
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • HonorHealth Research Institute - Biltmore ( Site 3043)
    • Tucson, Arizona, United States, 85711
      • Arizona Oncology Associates PC- HOPE ( Site 3049)
  • California
    • La Jolla, California, United States, 92093-0698
      • UCSD Moores Cancer Center ( Site 3053)
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University Of Colorado ( Site 3051)
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Smilow Cancer Hospital at Yale New Haven ( Site 3070)
  • Florida
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Cancer Center ( Site 3081)
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital ( Site 3036)
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital ( Site 3044)
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Cancer Institute ( Site 3067)
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Melvin and Bren Simon Cancer Center ( Site 3071)
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospital and Clinics ( Site 3046)
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute - St. Matthews ( Site 3056)
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • WK Physicians Network/Gynecologic Oncology Associates ( Site 3047)
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School ( Site 3037)
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center ( Site 3065)
    • Mineola, New York, United States, 11501
      • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 3076)
    • New York, New York, United States, 10016
      • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 3042)
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Center ( Site 3072)
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3080)
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
  • Oregon
    • Portland, Oregon, United States, 97210
      • Legacy Good Samaritan Medical Center ( Site 3033)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center - Jefferson Health ( Site 3078)
    • Pittsburgh, Pennsylvania, United States, 15224
      • AHN West Penn Hospital ( Site 3060)
    • Willow Grove, Pennsylvania, United States, 19090
      • Abington Hospital - Asplundh Cancer Center ( Site 3073)
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Gynecology Oncology ( Site 3045)
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center ( Site 3063)
  • Virginia
    • Richmond, Virginia, United States, 23298
      • VCU Massey Cancer Center ( Site 3068)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Has a histologically confirmed new diagnosis of Endometrial Carcinoma or Carcinosarcoma (Mixed Mullerian Tumor) and:

  • Has undergone curative intent surgery that included hysterectomy and bilateral salpingo-oophorectomy; and
  • Is at high risk for recurrence following treatment with curative intent surgery, ie: Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) 2009 surgical stage I/II with myometrial invasion of non-endometrioid histology; FIGO 2009 surgical stage I/II with myometrial invasion of any histology with known aberrant p53 expression or p53 mutation; or FIGO (2009) surgical stage III or IVA of any histology.
• Is disease-free with no evidence of loco-regional disease or distant metastasis post operatively and on imaging.
• Has not received any radiation or systemic therapy, including immunotherapy, hormonal therapy, or hyperthermic intraperitoneal chemotherapy (HIPEC), in any setting including the neoadjuvant setting for endometrial cancer (EC).
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
• Submission of a tumor tissue sample from current diagnosis of Endometrial Carcinoma or Carcinosarcoma for prospective determination of histology and mismatch repair (MMR) status by central vendor is required for all participants.
• Has adequate organ function within 7 days of randomization.

Exclusion Criteria:

• Has recurrent endometrial carcinoma or carcinosarcoma.
• Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas are also not allowed.
• Has FIGO (2009) Surgical Stage I/II EC of endometrioid histology without a known aberrant p53 expression or p53 mutation.
• Is known to have a deoxyribonucleic acid (DNA) polymerase epsilon catalytic subunit A (POLE) mutation.
• Has FIGO Stage IVB disease of any histology even if there is no evidence of disease after surgery.
• Has residual tumor whether measurable or non-measurable after surgery.

• Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.

  • Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in situ cancers.
• Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).

• Has received a live vaccine within 30 days before the first dose of study intervention.

  • Note: killed vaccines are allowed.
• Has a known intolerance to study intervention (or any of the excipients).

• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.

  • Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
• Has any contraindication to the use of carboplatin or paclitaxel.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
• Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
• Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
• Has an active infection requiring systemic therapy.
• Has a known history of HIV infection.
• Has a known history of Hepatitis B or known active Hepatitis C virus infection.
• Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
• Has had an allogenic tissue/solid organ transplant.
• Has not recovered adequately from surgery and/or any complications from the surgery.
• Is breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pembrolizumab + Chemotherapy; Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation.	Biological: Pembrolizumab; IV infusion; Other Names: MK-3475; KEYTRUDA®; Drug: Paclitaxel; IV infusion; Drug: Carboplatin; IV infusion; Drug: Docetaxel; IV infusion docetaxel 75 mg/m^2 Q3W or 25 mg/m2 QW may be given in place of paclitaxel following sponsor consultation if a participant experiences severe hypersensitivity to paclitaxel or an adverse event requiring discontinuation of paclitaxel.; Drug: Cisplatin; Cisplatin 75 mg/m^2 IV infusion Q3W may be given in place of carboplatin following sponsor consultation if a participant experiences severe hypersensitivity to carboplatin or an adverse event requiring discontinuation of carboplatin.; Other Names: Platinol®; Platinol®-AQ; Radiation: External Beam Radiotherapy (EBRT); ≥4500 cGY given according to local practice, at the discretion of the investigator; Drug: Cisplatin (as radiosensitizer); If a participant receives external beam radiotherapy (EBRT), then cisplatin 50 mg/m^2 IV infusion may be administered as a radiosensitizer at the discretion of the investigator, on days 1 and 29; Other Names: Platinol®; Platinol®-AQ; Radiation: Brachytherapy; Given according to local practice, at the discretion of the investigator; Other Names: Internal radiation therapy
Placebo Comparator: Placebo + Chemotherapy; Participants receive placebo to pembrolizumab intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of placebo, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation.	Drug: Paclitaxel; IV infusion; Drug: Carboplatin; IV infusion; Drug: Placebo for pembrolizumab; IV infusion; Drug: Docetaxel; IV infusion docetaxel 75 mg/m^2 Q3W or 25 mg/m2 QW may be given in place of paclitaxel following sponsor consultation if a participant experiences severe hypersensitivity to paclitaxel or an adverse event requiring discontinuation of paclitaxel.; Drug: Cisplatin; Cisplatin 75 mg/m^2 IV infusion Q3W may be given in place of carboplatin following sponsor consultation if a participant experiences severe hypersensitivity to carboplatin or an adverse event requiring discontinuation of carboplatin.; Other Names: Platinol®; Platinol®-AQ; Radiation: External Beam Radiotherapy (EBRT); ≥4500 cGY given according to local practice, at the discretion of the investigator; Drug: Cisplatin (as radiosensitizer); If a participant receives external beam radiotherapy (EBRT), then cisplatin 50 mg/m^2 IV infusion may be administered as a radiosensitizer at the discretion of the investigator, on days 1 and 29; Other Names: Platinol®; Platinol®-AQ; Radiation: Brachytherapy; Given according to local practice, at the discretion of the investigator; Other Names: Internal radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence	DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence, will be presented.	Up to approximately 42 months
Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to approximately 54 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-Free Survival (DFS) as Assessed Radiographically by Blinded Independent Central Review (BICR) or by Histopathologic Confirmation of Suspected Disease Recurrence	DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by BICR or by histopathologic confirmation of suspected disease recurrence, will be presented.	Up to approximately 42 months
Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Combined Positivity Score (CPS)-Determined Programmed Cell Death 1 Ligand 1 (PD-L1) Status	DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence by CPS-determined PD-L1 status will be presented.	Up to approximately 42 months
Overall Survival (OS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Combined Positivity Score (CPS)-Determined Programmed Cell Death 1 Ligand 1 (PD-L1) Status	OS is defined as the time from randomization to death due to any cause. The OS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence by CPS-determined PD-L1 status will be presented.	Up to approximately 54 months
Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Tumor Mutation Burden (TMB) Status	DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence by tumor mutation burden (TMB) status, will be presented.	Up to approximately 42 months
Overall Survival (OS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Tumor Mutation Burden (TMB) Status	OS is defined as the time from randomization to death due to any cause. The OS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence by tumor mutation burden (TMB) status will be presented.	Up to approximately 54 months
Number of Participants Who Experience One or More Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.	Up to approximately 54 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.	Up to approximately 52 weeks
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (QoL) Score	The EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. Participant responses to questions 29 ("How would you rate your overall health during the past week?") and 30 ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). A higher score indicates a better overall health/quality of life status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined scores will be presented.	Baseline and up to approximately 54 months
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Function Score	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=not at all to 4=very much). A higher score indicates a better quality of life. The change from baseline in physical function (EORTC QLQ-C30 Items 1-5) score will be presented.	Baseline and up to approximately 54 months
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Endometrial Cancer (EORTC QLQ-EN24) Score	The EORTC-QLQ-EN24 is a 24-item questionnaire developed to be used in conjunction with the EORTC-QLQ-C30 to assess the quality of life of endometrial cancer patients. Participant responses are scored on a 4-point scale (1=not at all to 4=very much). A higher score indicates a better quality of life. The change from baseline in EORTC QLQ-E24 score will be presented.	Baseline and up to approximately 54 months

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Collaborators: Gynecologic Oncology Group; European Network for Gynaecological Oncological Trial Groups
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2021
• Primary Completion (Estimated): June 18, 2025
• Study Completion (Estimated): June 18, 2025

Study Registration Dates

• First Submitted: November 12, 2020
• First Submitted That Met QC Criteria: November 12, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1); Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2 )
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometrial Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Docetaxel; Carboplatin; Paclitaxel; Cisplatin; Pembrolizumab
• Other Study ID Numbers: 3475-B21; KEYNOTE-B21 (Other Identifier: Merck); ENGOT-en11 (Other Identifier: European Network for Gynaecological Oncological Trial groups); GOG-3053 (Other Identifier: Gynecologic Oncology Group); jRCT2031200399 (Registry Identifier: jRCT); 2020-003424-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No