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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)

Primary Purpose

Endometrial Neoplasms

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Carboplatin
Paclitaxel
Placebo for pembrolizumab
Docetaxel
Cisplatin
External Beam Radiotherapy (EBRT)
Cisplatin (as radiosensitizer)
Brachytherapy
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Neoplasms focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2 )

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama - Birmingham ( Site 3061)
  • University of South Alabama, Mitchell Cancer Institute ( Site 3058)
  • HonorHealth Research Institute - Biltmore ( Site 3043)
  • Arizona Oncology Associates PC- HOPE ( Site 3049)
  • UCSD Moores Cancer Center ( Site 3053)
  • University Of Colorado ( Site 3051)
  • Smilow Cancer Hospital at Yale New Haven ( Site 3070)
  • Mount Sinai Cancer Center ( Site 3081)
  • Northside Hospital ( Site 3036)
  • Northwestern Memorial Hospital ( Site 3044)
  • Parkview Cancer Institute ( Site 3067)
  • Indiana University Melvin and Bren Simon Cancer Center ( Site 3071)
  • University of Iowa Hospital and Clinics ( Site 3046)
  • Norton Cancer Institute - St. Matthews ( Site 3056)
  • WK Physicians Network/Gynecologic Oncology Associates ( Site 3047)
  • University of Massachusetts Medical School ( Site 3037)
  • Montefiore Medical Center ( Site 3065)
  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 3076)
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 3042)
  • Duke Cancer Center ( Site 3072)
  • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3080)
  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
  • Legacy Good Samaritan Medical Center ( Site 3033)
  • Sidney Kimmel Cancer Center - Jefferson Health ( Site 3078)
  • AHN West Penn Hospital ( Site 3060)
  • Abington Hospital - Asplundh Cancer Center ( Site 3073)
  • Sanford Gynecology Oncology ( Site 3045)
  • UT Southwestern Medical Center ( Site 3063)
  • VCU Massey Cancer Center ( Site 3068)
  • Centro de Oncología e Investigación de Buenos Aires ( Site 1005)
  • IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 1006)
  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 1003)
  • Hospital Britanico de Buenos Aires ( Site 1002)
  • Instituto de Oncologia de Rosario ( Site 1004)
  • IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 1010)
  • Hospital Aleman ( Site 1001)
  • CEMIC ( Site 1009)
  • Centro Oncologico Riojano Integral ( Site 1007)
  • Medizinische Universitat Graz ( Site 2004)
  • Medizinische Universitaet Innsbruck ( Site 2001)
  • Saint-Luc UCL ( Site 2042)
  • C.I.U. Hopital Ambroise Pare ( Site 2039)
  • CHR Verviers ( Site 2035)
  • OLV Ziekenhuis ( Site 2038)
  • AZ Maria Middelares Gent ( Site 2032)
  • Universitair Ziekenhuis Gent ( Site 2037)
  • AZ Nikolaas ( Site 2031)
  • UZ Leuven ( Site 2040)
  • AZ Groeninge ( Site 2036)
  • CHC - Groupe Sante ( Site 2041)
  • CHU Liege Sart-Tilman ( Site 2044)
  • Tom Baker Cancer Centre ( Site 3007)
  • Kingston Health Sciences Centre ( Site 3003)
  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 3006)
  • McGill University Health Centre ( Site 3005)
  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 3
  • Centro Investigación del Cáncer James Lind ( Site 1061)
  • Fundacion Arturo Lopez Perez FALP ( Site 1062)
  • Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063)
  • Bradfordhill-Clinical Area ( Site 1070)
  • Oncocentro ( Site 1065)
  • Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 4034)
  • Beijing Cancer Hospital ( Site 4048)
  • Peking Union Medical College Hospital ( Site 4036)
  • Chongqing Cancer Hospital ( Site 4040)
  • The First Affiliated Hospital of Xiamen University ( Site 4060)
  • The First Affiliated Hospital ( Site 4043)
  • Guangxi Medical University Affiliated Tumor Hospital ( Site 4049)
  • Harbin Medical University Cancer Hospital ( Site 4033)
  • Hubei Cancer Hospital ( Site 4059)
  • Xiangya Hospital Central-South University ( Site 4035)
  • Hunan Cancer Hospital ( Site 4050)
  • Nanjing Drum Tower Hospital ( Site 4037)
  • Jiangxi Maternal and Child Health Hospital ( Site 4051)
  • The First Bethune Hospital of Jilin University ( Site 4057)
  • The First Affiliated Hospital of Xi an Jiaotong University ( Site 4045)
  • Obstetrics and Gynecology Hosp. Fudan University ( Site 4041)
  • Shanghai Renji Hospital Affiliated to Jiao Tong University ( Site 4053)
  • Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 4001)
  • Sichuan Cancer Hospital ( Site 4039)
  • Tianjin Medical University Cancer Institute & Hospital ( Site 4054)
  • Yunnan Province Cancer Hospital-Gynecology Department ( Site 4055)
  • The First Affiliated Hospital, Zhejiang University-Gynecology ( Site 4002)
  • Women s Hospital School of Medicine Zhejiang University ( Site 4032)
  • The First Affiliated Hospital of Wenzhou Medical University ( Site 4056)
  • Clínica Vida Fundación - Sede Poblado ( Site 1096)
  • Instituto Nacional de Cancerología E.S.E ( Site 1094)
  • Instituto Cancerologico de Narino Ltda ( Site 1092)
  • Fundacion Valle del Lili ( Site 1093)
  • Fakultní nemocnice Brno Bohunice-Gynekologicko-porodnicka klinika ( Site 2394)
  • Fakultni nemocnice Kralovske Vinohrady ( Site 2393)
  • Vseobecna fakultni nemocnice v Praze ( Site 2391)
  • Fakultni nemocnice Olomouc ( Site 2392)
  • Rigshospitalet University Hospital ( Site 2515)
  • Herlev Hospital ( Site 2514)
  • Aalborg Universitetshospital ( Site 2511)
  • Roskilde Sygehus ( Site 2513)
  • Odense Universitetshospital ( Site 2512)
  • Tampere University Hospital ( Site 2541)
  • Kuopio University Hospital ( Site 2543)
  • Turku University Hospital ( Site 2542)
  • Institut De Cancerologie De Lorraine ( Site 2072)
  • Centre Antoine Lacassagne ( Site 2073)
  • Centre Francois Baclesse ( Site 2062)
  • Hôpital Privé Des Côtes d'Armor ( Site 2063)
  • CHU Besancon - Hopital Jean Minjoz ( Site 2068)
  • Institut Bergonie ( Site 2067)
  • Institut Universitaire du Cancer Toulouse - Oncopole ( Site 2065)
  • Institut Regional du Cancer de Montpellier - ICM ( Site 2069)
  • Hopital Cochin ( Site 2070)
  • Gustave Roussy ( Site 2071)
  • Hopital prive du Confluent ( Site 2061)
  • Centre Hospitalier Lyon Sud ( Site 2064)
  • SLK-Kliniken Heilbronn GmbH ( Site 2116)
  • Klinikum Ludwigsburg ( Site 2111)
  • Universitaetsklinikum Tuebingen ( Site 2113)
  • Medizinische Hochschule Hannover-Department of Obstetrics and Gynecology ( Site 2109)
  • Universitätsklinikum Bonn-Gynaecological oncology ( Site 2103)
  • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 2105)
  • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur
  • Universitätsklinikum Schleswig-Holstein ( Site 2101)
  • General Hospital of Patras. St Andrews ( Site 2421)
  • Geniko Panepistimako Nosokomeio ARETEIO ( Site 2423)
  • Perifereiako Geniko Nosokomeio ALEXANDRA ( Site 2425)
  • Athens University Hospital ATTIKON ( Site 2424)
  • Hospital Hygeia ( Site 2426)
  • Euromedica General Clinic of Thessaloniki ( Site 2422)
  • Rambam Medical Center ( Site 2307)
  • Edith Wolfson Medical Center ( Site 2306)
  • Hadassah Medical Center. Ein Kerem ( Site 2303)
  • Rabin Medical Center ( Site 2305)
  • Chaim Sheba Medical Center ( Site 2301)
  • Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 2121)
  • Fondazione Policlinico Universitario Agostino Gemelli ( Site 2124)
  • Istituto di Candiolo - IRCCS ( Site 2125)
  • Azienda Ospedaliera Spedali Civili di Brescia ( Site 2135)
  • IRCCS Ospedale San Raffaele ( Site 2130)
  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2122)
  • Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 2132)
  • Azienda Ospedaliera Universitaria Federico II ( Site 2123)
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2127)
  • Istituto Oncologico Veneto IRCCS-Oncologia 2 ( Site 2134)
  • Aichi Cancer Center Hospital ( Site 4190)
  • National Cancer Center Hospital East ( Site 4197)
  • National Hospital Organization Shikoku Cancer Center ( Site 4181)
  • Ehime University Hospital ( Site 4187)
  • Kurume University Hospital ( Site 4186)
  • Gunma Prefectural Cancer Center ( Site 4183)
  • Hokkaido University Hospital ( Site 4194)
  • Hyogo Cancer Center ( Site 4195)
  • Iwate Medical University Hospital ( Site 4189)
  • University of the Ryukyus Hospital ( Site 4184)
  • Saitama Medical University International Medical Center ( Site 4182)
  • Shizuoka Cancer Center Hospital and Research Institute ( Site 4192)
  • National Hospital Organization Kyushu Cancer Center ( Site 4193)
  • Niigata Cancer Center Hospital ( Site 4185)
  • Osaka International Cancer Institute ( Site 4188)
  • The Cancer Institute Hospital of JFCR ( Site 4196)
  • Keio University Hospital ( Site 4191)
  • National Cancer Center ( Site 4065)
  • Seoul National University Bundang Hospital ( Site 4063)
  • Severance Hospital Yonsei University Health System ( Site 4062)
  • Asan Medical Center ( Site 4061)
  • Samsung Medical Center ( Site 4064)
  • Investigacion Onco Farmaceutica S de RL de CV ( Site 1127)
  • Hospital San Lucas Cardiologica del Sureste ( Site 1122)
  • Instituto Nacional de Cancerologia ( Site 1124)
  • Christus Muguerza Clinica Vidriera ( Site 1125)
  • I Can Oncology Center SA de CV ( Site 1126)
  • Hospital Angeles Roma ( Site 1123)
  • Centro Oncologico Internacional. SEDNA ( Site 1121)
  • University Hospital of North Norway ( Site 2153)
  • Soerlandet sykehus HF Kristiansand ( Site 2152)
  • Oslo Universitetssykehus Radiumhospitalet ( Site 2151)
  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2487)
  • Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2481)
  • Bialostockie Centrum Onkologii ( Site 2483)
  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2482)
  • Swietokrzyskie Centrum Onkologii SPZOZ ( Site 2485)
  • SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2486)
  • Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 2484)
  • Arkhangelsk Clinical Oncological Dispensary ( Site 2637)
  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 2645)
  • Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 2644)
  • Krasnoyarsk Regional Clinical oncology dispensary ( Site 2643)
  • National Research Ogarev Mordovia State University ( Site 2648)
  • FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 2634)
  • Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2631)
  • Nizhegorodsky Regional Oncology Dispensary-chemotherapy department (Branch№1) ( Site 2639)
  • Samara Regional Clinical Oncology Center-Chemotherapy Dapartment ( Site 2649)
  • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2636)
  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2646)
  • Tomsk Scientific Research Institute of Oncology-Chemotherapy ( Site 2638)
  • Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2641)
  • Hospital Josep Trueta ( Site 2184)
  • Clinica Universitaria de Navarra ( Site 2181)
  • Hospital Vall D Hebron ( Site 2182)
  • Hospital Clinic i Provincial ( Site 2185)
  • Hospital Universitario Reina Sofia ( Site 2183)
  • Hospital Clinico San Carlos ( Site 2187)
  • Hospital Universitario La Paz ( Site 2186)
  • Universitetssjukhuset i Linkoping. ( Site 2222)
  • Karolinska Universitetssjukhuset Solna ( Site 2220)
  • Blod-och Tumorsjukdomar ( Site 2221)
  • Changhua Christian Hospital ( Site 4095)
  • Taichung Veterans General Hospital ( Site 4094)
  • MacKay Memorial Hospital ( Site 4092)
  • Taipei Veterans General Hospital ( Site 4093)
  • Linkou Chang Gung Memorial Hospital ( Site 4091)
  • Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2355)
  • Cukurova Uni. Tip Fakultesi ( Site 2353)
  • Baskent Universitesi Ankara Hastanesi ( Site 2354)
  • Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 2350)
  • Medipol Universite Hastanesi ( Site 2352)
  • Ege University Medical Faculty ( Site 2351)
  • I.E.U. Medical Point Hastanesi ( Site 2356)
  • Chernihiv Medical Center of Modern Oncology ( Site 2368)
  • Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 2366)
  • SO Grigoriev Institute for Medical Radiology and Oncology of NAMS of Ukraine ( Site 2363)
  • MNE "Khmelnytskyi regional antitumor center" ( Site 2365)
  • LISOD - Israeli Oncological Hospital MedX-ray International Group, LLC ( Site 2364)
  • Lviv State Regional Oncological Center ( Site 2361)
  • The Municipal Enterprise Volyn Regional Medical Oncology Centre ( Site 2362)
  • Bristol Haematology and Oncology Centre ( Site 2244)
  • Castle Hill Hospital-Academic Oncology ( Site 2252)
  • Beatson West of Scotland Cancer Centre ( Site 2247)
  • UCLH NHS Foundation Trust ( Site 2242)
  • Royal Marsden NHS Foundation Trust ( Site 2248)
  • Royal Marsden Hospital Sutton-Surrey ( Site 2241)
  • Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 2249)
  • The Christie Hospital NHS Foundation Trust ( Site 2243)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pembrolizumab + Chemotherapy

Placebo + Chemotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 12, 2020
Last Updated
October 10, 2022
Sponsor
Merck Sharp & Dohme LLC
Collaborators
European Network for Gynaecological Oncological Trial Groups, Gynecologic Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT04634877
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
June 18, 2025 (Anticipated)
Study Completion Date
June 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
European Network for Gynaecological Oncological Trial Groups, Gynecologic Oncology Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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 )

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
990 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab + Chemotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo + Chemotherapy
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
KEYTRUDA®, MK-3475
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo for pembrolizumab
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol®, Platinol®-AQ
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiotherapy (EBRT)
Intervention Description
≥4500 cGY given according to local practice, at the discretion of the investigator
Intervention Type
Drug
Intervention Name(s)
Cisplatin (as radiosensitizer)
Other Intervention Name(s)
Platinol®, Platinol®-AQ
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
Brachytherapy
Other Intervention Name(s)
Internal radiation therapy
Intervention Description
Given according to local practice, at the discretion of the investigator
Primary Outcome Measure Information:
Title
Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence
Description
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.
Time Frame
Up to approximately 42 months
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 54 months
Secondary Outcome Measure Information:
Title
Disease-Free Survival (DFS) as Assessed Radiographically by Blinded Independent Central Review (BICR) or by Histopathologic Confirmation of Suspected Disease Recurrence
Description
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.
Time Frame
Up to approximately 42 months
Title
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
Description
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.
Time Frame
Up to approximately 42 months
Title
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
Description
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.
Time Frame
Up to approximately 54 months
Title
Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Tumor Mutation Burden (TMB) Status
Description
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.
Time Frame
Up to approximately 42 months
Title
Overall Survival (OS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Tumor Mutation Burden (TMB) Status
Description
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.
Time Frame
Up to approximately 54 months
Title
Number of Participants Who Experience One or More Adverse Events (AEs)
Description
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.
Time Frame
Up to approximately 54 months
Title
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Description
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.
Time Frame
Up to approximately 52 weeks
Title
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
Description
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.
Time Frame
Baseline and up to approximately 54 months
Title
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Function Score
Description
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.
Time Frame
Baseline and up to approximately 54 months
Title
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
Description
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.
Time Frame
Baseline and up to approximately 54 months

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
http://merckoncologyclinicaltrials.com
Description
Merck Oncology Clinical Trials Information

Learn more about this trial

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)

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