Clinical trial NCT04634877: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Endometrial Neoplasms
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2 )
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: European Network for Gynaecological Oncological Trial Groups
name: Gynecologic Oncology Group
First posted: 2020-11-18
Enrollment: 990
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence
timeFrame: Up to approximately 42 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 54 months
Secondary outcomes:
measure: Disease-Free Survival (DFS) as Assessed Radiographically by Blinded Independent Central Review (BICR) or by Histopathologic Confirmation of Suspected Disease Recurrence
timeFrame: Up to approximately 42 months
measure: 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
timeFrame: Up to approximately 42 months
measure: 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
timeFrame: Up to approximately 54 months
measure: Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Tumor Mutation Burden (TMB) Status
timeFrame: Up to approximately 42 months
measure: Overall Survival (OS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Tumor Mutation Burden (TMB) Status
timeFrame: Up to approximately 54 months
measure: Number of Participants Who Experience One or More Adverse Events (AEs)
timeFrame: Up to approximately 54 months
measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to approximately 52 weeks
measure: 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
timeFrame: Baseline and up to approximately 54 months
measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Function Score
timeFrame: Baseline and up to approximately 54 months
measure: 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
timeFrame: Baseline and up to approximately 54 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Birmingham ( Site 3061)
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama, Mitchell Cancer Institute ( Site 3058)
state: Alabama
city: Phoenix
country: United States
facility: HonorHealth Research Institute - Biltmore ( Site 3043)
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates PC- HOPE ( Site 3049)
state: Arizona
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center ( Site 3053)
state: California
city: Aurora
country: United States
facility: University Of Colorado ( Site 3051)
state: Colorado
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale New Haven ( Site 3070)
state: Connecticut
city: Miami Beach
country: United States
facility: Mount Sinai Cancer Center ( Site 3081)
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital ( Site 3036)
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital ( Site 3044)
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Cancer Institute ( Site 3067)
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center ( Site 3071)
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics ( Site 3046)
state: Iowa
city: Louisville
country: United States
facility: Norton Cancer Institute - St. Matthews ( Site 3056)
state: Kentucky
city: Shreveport
country: United States
facility: WK Physicians Network/Gynecologic Oncology Associates ( Site 3047)
state: Louisiana
city: Worcester
country: United States
facility: University of Massachusetts Medical School ( Site 3037)
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center ( Site 3065)
state: New York
city: Mineola
country: United States
facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 3076)
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 3042)
state: New York
city: Durham
country: United States
facility: Duke Cancer Center ( Site 3072)
state: North Carolina
city: Fargo
country: United States
facility: Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3080)
state: North Dakota
city: Columbus
country: United States
facility: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
state: Ohio
city: Portland
country: United States
facility: Legacy Good Samaritan Medical Center ( Site 3033)
state: Oregon
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center - Jefferson Health ( Site 3078)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: AHN West Penn Hospital ( Site 3060)
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Hospital - Asplundh Cancer Center ( Site 3073)
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Gynecology Oncology ( Site 3045)
state: South Dakota
city: Dallas
country: United States
facility: UT Southwestern Medical Center ( Site 3063)
state: Texas
city: Richmond
country: United States
facility: VCU Massey Cancer Center ( Site 3068)
state: Virginia
city: Berazategui
country: Argentina
facility: Centro de Oncología e Investigación de Buenos Aires ( Site 1005)
state: Buenos Aires
city: Caba
country: Argentina
facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 1006)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clinicas Mar del Plata ( Site 1003)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires ( Site 1002)
state: Caba
city: Rosario
country: Argentina
facility: Instituto de Oncologia de Rosario ( Site 1004)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 1010)
city: Buenos Aires
country: Argentina
facility: Hospital Aleman ( Site 1001)
city: Buenos Aires
country: Argentina
facility: CEMIC ( Site 1009)
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral ( Site 1007)
city: Graz
country: Austria
facility: Medizinische Universitat Graz ( Site 2004)
state: Steiermark
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck ( Site 2001)
state: Tirol
city: Bruxelles
country: Belgium
facility: Saint-Luc UCL ( Site 2042)
state: Bruxelles-Capitale, Region De
city: Mons
country: Belgium
facility: C.I.U. Hopital Ambroise Pare ( Site 2039)
state: Hainaut
city: Verviers
country: Belgium
facility: CHR Verviers ( Site 2035)
state: Liege
city: Aalst
country: Belgium
facility: OLV Ziekenhuis ( Site 2038)
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: AZ Maria Middelares Gent ( Site 2032)
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent ( Site 2037)
state: Oost-Vlaanderen
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas ( Site 2031)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven ( Site 2040)
state: Vlaams-Brabant
city: Kortrijk
country: Belgium
facility: AZ Groeninge ( Site 2036)
state: West-Vlaanderen
city: Liege
country: Belgium
facility: CHC - Groupe Sante ( Site 2041)
city: Liege
country: Belgium
facility: CHU Liege Sart-Tilman ( Site 2044)
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre ( Site 3007)
state: Alberta
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre ( Site 3003)
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 3006)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre ( Site 3005)
state: Quebec
city: Quebec City
country: Canada
facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 3
state: Quebec
city: Temuco
country: Chile
facility: Centro Investigación del Cáncer James Lind ( Site 1061)
state: Araucania
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez FALP ( Site 1062)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill-Clinical Area ( Site 1070)
state: Region M. De Santiago
city: Vina del Mar
country: Chile
facility: Oncocentro ( Site 1065)
state: Valparaiso
city: Hefei
country: China
facility: Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 4034)
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 4048)
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital ( Site 4036)
state: Beijing
city: Chongqing
country: China
facility: Chongqing Cancer Hospital ( Site 4040)
state: Chongqing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University ( Site 4060)
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital ( Site 4043)
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital ( Site 4049)
state: Guangxi
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital ( Site 4033)
state: Heilongjiang
city: Wuhan
country: China
facility: Hubei Cancer Hospital ( Site 4059)
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central-South University ( Site 4035)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 4050)
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital ( Site 4037)
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health Hospital ( Site 4051)
state: Jiangxi
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University ( Site 4057)
state: Jilin
city: XI An
country: China
facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 4045)
state: Shaanxi
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hosp. Fudan University ( Site 4041)
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Renji Hospital Affiliated to Jiao Tong University ( Site 4053)
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 4001)
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Cancer Hospital ( Site 4039)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital ( Site 4054)
state: Tianjin
city: Kunming
country: China
facility: Yunnan Province Cancer Hospital-Gynecology Department ( Site 4055)
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University-Gynecology ( Site 4002)
state: Zhejiang
city: Hangzhou
country: China
facility: Women s Hospital School of Medicine Zhejiang University ( Site 4032)
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University ( Site 4056)
state: Zhejiang
city: Medellin
country: Colombia
facility: Clínica Vida Fundación - Sede Poblado ( Site 1096)
state: Antioquia
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerología E.S.E ( Site 1094)
state: Distrito Capital De Bogota
city: San Juan De Pasto
country: Colombia
facility: Instituto Cancerologico de Narino Ltda ( Site 1092)
state: Narino
city: Cali
country: Colombia
facility: Fundacion Valle del Lili ( Site 1093)
state: Valle Del Cauca
city: Brno
country: Czechia
facility: Fakultní nemocnice Brno Bohunice-Gynekologicko-porodnicka klinika ( Site 2394)
state: Brno-mesto
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady ( Site 2393)
state: Praha 10
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze ( Site 2391)
state: Praha 2
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc ( Site 2392)
city: Copehagen
country: Denmark
facility: Rigshospitalet University Hospital ( Site 2515)
state: Hovedstaden
city: Herlev
country: Denmark
facility: Herlev Hospital ( Site 2514)
state: Hovedstaden
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital ( Site 2511)
state: Nordjylland
city: Roskilde
country: Denmark
facility: Roskilde Sygehus ( Site 2513)
state: Sjaelland
city: Odense
country: Denmark
facility: Odense Universitetshospital ( Site 2512)
state: Syddanmark
city: Tampere
country: Finland
facility: Tampere University Hospital ( Site 2541)
state: Pirkanmaa
city: Kuopio
country: Finland
facility: Kuopio University Hospital ( Site 2543)
state: Pohjois-Savo
city: Turku
country: Finland
facility: Turku University Hospital ( Site 2542)
state: Varsinais-Suomi
city: Vandoeuvre les Nancy
country: France
facility: Institut De Cancerologie De Lorraine ( Site 2072)
state: Ain
city: Nice
country: France
facility: Centre Antoine Lacassagne ( Site 2073)
state: Alpes-Maritimes
city: Caen
country: France
facility: Centre Francois Baclesse ( Site 2062)
state: Calvados
city: Plérin
country: France
facility: Hôpital Privé Des Côtes d'Armor ( Site 2063)
state: Cotes-d Armor
city: Besancon
country: France
facility: CHU Besancon - Hopital Jean Minjoz ( Site 2068)
state: Doubs
city: Bordeaux
country: France
facility: Institut Bergonie ( Site 2067)
state: Gironde
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole ( Site 2065)
state: Haute-Garonne
city: Montpellier
country: France
facility: Institut Regional du Cancer de Montpellier - ICM ( Site 2069)
state: Herault
city: Paris
country: France
facility: Hopital Cochin ( Site 2070)
state: Ile-de-France
city: Villejuif
country: France
facility: Gustave Roussy ( Site 2071)
state: Ile-de-France
city: Nantes
country: France
facility: Hopital prive du Confluent ( Site 2061)
state: Loire-Atlantique
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud ( Site 2064)
state: Rhone
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn GmbH ( Site 2116)
state: Baden-Wurttemberg
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg ( Site 2111)
state: Baden-Wurttemberg
city: Tübingen
country: Germany
facility: Universitaetsklinikum Tuebingen ( Site 2113)
state: Baden-Wurttemberg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover-Department of Obstetrics and Gynecology ( Site 2109)
state: Niedersachsen
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn-Gynaecological oncology ( Site 2103)
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 2105)
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur
state: Sachsen
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein ( Site 2101)
state: Schleswig-Holstein
city: Patras
country: Greece
facility: General Hospital of Patras. St Andrews ( Site 2421)
state: Achaia
city: Athens
country: Greece
facility: Geniko Panepistimako Nosokomeio ARETEIO ( Site 2423)
state: Attiki
city: Athens
country: Greece
facility: Perifereiako Geniko Nosokomeio ALEXANDRA ( Site 2425)
state: Attiki
city: Chaidari
country: Greece
facility: Athens University Hospital ATTIKON ( Site 2424)
state: Attiki
city: Marousi
country: Greece
facility: Hospital Hygeia ( Site 2426)
state: Attiki
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic of Thessaloniki ( Site 2422)
city: Haifa
country: Israel
facility: Rambam Medical Center ( Site 2307)
city: Holon
country: Israel
facility: Edith Wolfson Medical Center ( Site 2306)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center. Ein Kerem ( Site 2303)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 2305)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center ( Site 2301)
city: Roma
country: Italy
facility: Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 2121)
state: Abruzzo
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli ( Site 2124)
state: Lazio
city: Candiolo
country: Italy
facility: Istituto di Candiolo - IRCCS ( Site 2125)
state: Piemonte
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia ( Site 2135)
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele ( Site 2130)
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2122)
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 2132)
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II ( Site 2123)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2127)
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS-Oncologia 2 ( Site 2134)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 4190)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 4197)
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 4181)
state: Ehime
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 4187)
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 4186)
state: Fukuoka
city: Ota
country: Japan
facility: Gunma Prefectural Cancer Center ( Site 4183)
state: Gunma
city: Sapporo
country: Japan
facility: Hokkaido University Hospital ( Site 4194)
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Cancer Center ( Site 4195)
state: Hyogo
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital ( Site 4189)
state: Iwate
city: Nakagami-gun
country: Japan
facility: University of the Ryukyus Hospital ( Site 4184)
state: Okinawa
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center ( Site 4182)
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 4192)
state: Shizuoka
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 4193)
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 4185)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 4188)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 4196)
city: Tokyo
country: Japan
facility: Keio University Hospital ( Site 4191)
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 4065)
state: Kyonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 4063)
state: Kyonggi-do
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 4062)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 4061)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 4064)
city: La Paz
country: Mexico
facility: Investigacion Onco Farmaceutica S de RL de CV ( Site 1127)
state: Baja California Sur
city: Tuxtla Gutierrez
country: Mexico
facility: Hospital San Lucas Cardiologica del Sureste ( Site 1122)
state: Chiapas
city: Cdmx
country: Mexico
facility: Instituto Nacional de Cancerologia ( Site 1124)
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Christus Muguerza Clinica Vidriera ( Site 1125)
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: I Can Oncology Center SA de CV ( Site 1126)
state: Nuevo Leon
city: Ciudad de Mexico
country: Mexico
facility: Hospital Angeles Roma ( Site 1123)
city: Mexico City
country: Mexico
facility: Centro Oncologico Internacional. SEDNA ( Site 1121)
city: Tromso
country: Norway
facility: University Hospital of North Norway ( Site 2153)
state: Troms
city: Kristiansand
country: Norway
facility: Soerlandet sykehus HF Kristiansand ( Site 2152)
state: Vest-Agder
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Radiumhospitalet ( Site 2151)
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2487)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2481)
state: Mazowieckie
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii ( Site 2483)
state: Podlaskie
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2482)
state: Slaskie
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii SPZOZ ( Site 2485)
state: Swietokrzyskie
city: Olsztyn
country: Poland
facility: SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2486)
state: Warminsko-mazurskie
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 2484)
state: Wielkopolskie
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Clinical Oncological Dispensary ( Site 2637)
state: Arkhangel Skaya Oblast
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 2645)
state: Baskortostan, Respublika
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 2644)
state: Chelyabinskaya Oblast
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Clinical oncology dispensary ( Site 2643)
state: Krasnoyarskiy Kray
city: Saransk
country: Russian Federation
facility: National Research Ogarev Mordovia State University ( Site 2648)
state: Mordoviya, Respublika
city: Moscow
country: Russian Federation
facility: FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 2634)
state: Moskva
city: Moscow
country: Russian Federation
facility: Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2631)
state: Moskva
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhegorodsky Regional Oncology Dispensary-chemotherapy department (Branch№1) ( Site 2639)
state: Nizhegorodskaya Oblast
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Oncology Center-Chemotherapy Dapartment ( Site 2649)
state: Samarskaya Oblast
city: Saint-Petersburg
country: Russian Federation
facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2636)
state: Sankt-Peterburg
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2646)
state: Tatarstan, Respublika
city: Tomsk
country: Russian Federation
facility: Tomsk Scientific Research Institute of Oncology-Chemotherapy ( Site 2638)
state: Tomskaya Oblast
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2641)
state: Yaroslavskaya Oblast
city: Girona
country: Spain
facility: Hospital Josep Trueta ( Site 2184)
state: Gerona
city: Madrid
country: Spain
facility: Clinica Universitaria de Navarra ( Site 2181)
state: Madrid, Comunidad De
city: Barcelona
country: Spain
facility: Hospital Vall D Hebron ( Site 2182)
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial ( Site 2185)
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia ( Site 2183)
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos ( Site 2187)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz ( Site 2186)
city: Linkoping
country: Sweden
facility: Universitetssjukhuset i Linkoping. ( Site 2222)
state: Ostergotlands Lan
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset Solna ( Site 2220)
state: Stockholms Lan
city: Uppsala
country: Sweden
facility: Blod-och Tumorsjukdomar ( Site 2221)
state: Uppsala Lan
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital ( Site 4095)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 4094)
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital ( Site 4092)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 4093)
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital ( Site 4091)
city: Adana
country: Turkey
facility: Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2355)
city: Adana
country: Turkey
facility: Cukurova Uni. Tip Fakultesi ( Site 2353)
city: Ankara
country: Turkey
facility: Baskent Universitesi Ankara Hastanesi ( Site 2354)
city: Ankara
country: Turkey
facility: Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 2350)
city: Istanbul
country: Turkey
facility: Medipol Universite Hastanesi ( Site 2352)
city: Izmir
country: Turkey
facility: Ege University Medical Faculty ( Site 2351)
city: Izmir
country: Turkey
facility: I.E.U. Medical Point Hastanesi ( Site 2356)
city: Chernihiv
country: Ukraine
facility: Chernihiv Medical Center of Modern Oncology ( Site 2368)
state: Chernihivska Oblast
city: Chernivtsi
country: Ukraine
facility: Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 2366)
state: Chernivetska Oblast
city: Kharkiv
country: Ukraine
facility: SO Grigoriev Institute for Medical Radiology and Oncology of NAMS of Ukraine ( Site 2363)
state: Kharkivska Oblast
city: Khmelnitskyi
country: Ukraine
facility: MNE "Khmelnytskyi regional antitumor center" ( Site 2365)
state: Khmelnytska Oblast
city: Kiev
country: Ukraine
facility: LISOD - Israeli Oncological Hospital MedX-ray International Group, LLC ( Site 2364)
state: Kyivska Oblast
city: Lviv
country: Ukraine
facility: Lviv State Regional Oncological Center ( Site 2361)
state: Lvivska Oblast
city: Lutsk
country: Ukraine
facility: The Municipal Enterprise Volyn Regional Medical Oncology Centre ( Site 2362)
state: Volynska Oblast
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre ( Site 2244)
state: Bristol, City Of
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital-Academic Oncology ( Site 2252)
state: East Riding Of Yorkshire
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre ( Site 2247)
state: Glasgow City
city: London
country: United Kingdom
facility: UCLH NHS Foundation Trust ( Site 2242)
state: London, City Of
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust ( Site 2248)
state: London, City Of
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital Sutton-Surrey ( Site 2241)
state: London, City Of
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 2249)
city: Manchester
country: United Kingdom
facility: The Christie Hospital NHS Foundation Trust ( Site 2243)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Van Gorp T, Cibula D, Lv W, Backes F, Ortac F, Hasegawa K, Lindemann K, Savarese A, Laenen A, Kim YM, Bodnar L, Barretina-Ginesta MP, Gilbert L, Pothuri B, Chen X, Flores MB, Levy T, Colombo N, Papadimitriou C, Buchanan T, Hanker LC, Eminowicz G, Rob L, Black D, Lichfield J, Lin G, Orlowski R, Keefe S, Lortholary A, Slomovitz B; ENGOT-en11/GOG-3053/KEYNOTE-B21 investigators. ENGOT-en11/GOG-3053/KEYNOTE-B21: a randomised, double-blind, phase III study of pembrolizumab or placebo plus adjuvant chemotherapy with or without radiotherapy in patients with newly diagnosed, high-risk endometrial cancer. Ann Oncol. 2024 Nov;35(11):968-980. doi: 10.1016/j.annonc.2024.08.2242. Epub 2024 Sep 14.
citation: Slomovitz BM, Cibula D, Lv W, Ortac F, Hietanen S, Backes F, Kikuchi A, Lorusso D, Danska-Bidzinska A, Samouelian V, Barretina-Ginesta MP, Vulsteke C, Lai CH, Pothuri B, Zhang Y, Magallanes-Maciel M, Amit A, Guarneri V, Zagouri F, Bell M, Welz J, Eminowicz G, Hruda M, Willmott LJ, Lichfield J, Wang W, Orlowski R, Aktan G, Gladieff L, Van Gorp T. Pembrolizumab or Placebo Plus Adjuvant Chemotherapy With or Without Radiotherapy for Newly Diagnosed, High-Risk Endometrial Cancer: Results in Mismatch Repair-Deficient Tumors. J Clin Oncol. 2025 Jan 20;43(3):251-259. doi: 10.1200/JCO-24-01887. Epub 2024 Oct 16.