Spots Global Cancer Trial Database for Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)
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Trial Identification
Brief Title: Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)
Official Title: A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001)
Study ID: NCT03884101
Conditions
Study Description
Brief Summary: The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS). As of Amendment 7 eligible participants on study completion will be able to transition to an extension study, if available, in which they can continue to receive pembrolizumab monotherapy, lenvatinib monotherapy, or a combination of both pembrolizumab and lenvatinib as received in the parent study.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of South Alabama, Mitchell Cancer Institute ( Site 0245), Mobile, Alabama, United States
Arizona Oncology Associates PC- HOPE ( Site 8005), Tucson, Arizona, United States
UCLA Hematology and Oncology Clinic (Westwood) ( Site 0233), Los Angeles, California, United States
University of Colorado Cancer Center ( Site 0204), Aurora, Colorado, United States
Smilow Cancer Hospital at Yale New Haven ( Site 0202), New Haven, Connecticut, United States
University of Miami Health System ( Site 0249), Miami, Florida, United States
Georgia Cancer Center at Augusta University ( Site 0222), Augusta, Georgia, United States
Women's Cancer Care ( Site 0208), Covington, Louisiana, United States
Maine Medical Partners ( Site 0217), Scarborough, Maine, United States
Minnesota Oncology Hematology, PA ( Site 8003), Minneapolis, Minnesota, United States
Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 0268), Basking Ridge, New Jersey, United States
John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0226), Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0273), Middletown, New Jersey, United States
MSKCC-Bergen ( Site 0276), Montvale, New Jersey, United States
Holy Name Medical Center ( Site 0235), Teaneck, New Jersey, United States
Memorial Sloan-Kettering Cancer Center at Commack ( Site 0267), Commack, New York, United States
Memorial Sloan Kettering Cancer Center - West Harrison ( Site 0274), Harrison, New York, United States
The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0206), New York, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0246), New York, New York, United States
University of Rochester ( Site 0238), Rochester, New York, United States
Memorial Sloan Kettering Cancer Center - Nassau ( Site 0275), Uniondale, New York, United States
University of North Carolina- Chapel Hill ( Site 0254), Chapel Hill, North Carolina, United States
Roger Maris Cancer Center ( Site 0277), Fargo, North Dakota, United States
Willamette Valley Cancer Institute and Research Center ( Site 8004), Eugene, Oregon, United States
Sanford Cancer Center Oncology Clinic ( Site 0205), Sioux Falls, South Dakota, United States
Parkland Health & Hospital System ( Site 0272), Dallas, Texas, United States
University of Texas Southwestern Medical Center ( Site 0264), Dallas, Texas, United States
Texas Oncology-The Woodlands ( Site 8000), The Woodlands, Texas, United States
Legacy Salmon Creek Medical Center ( Site 0253), Vancouver, Washington, United States
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2607), Caba, Buenos Aires, Argentina
Hospital Italiano de La Plata ( Site 2601), La Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 2606), Mar del Plata, Buenos Aires, Argentina
Hospital Aleman ( Site 2600), Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires ( Site 2603), Buenos Aires, , Argentina
Centro Oncologico Riojano Integral ( Site 2605), La Rioja, , Argentina
Chris OBrien Lifehouse ( Site 1605), Camperdown, New South Wales, Australia
Prince of Wales Hospital [Australia] ( Site 1603), Randwick, New South Wales, Australia
Royal North Shore Hospital ( Site 1600), St Leonards, New South Wales, Australia
The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 1602), Westmead, New South Wales, Australia
Mater Misericordiae Ltd ( Site 1608), South Brisbane, Queensland, Australia
Monash Health ( Site 1606), Clayton, Victoria, Australia
Epworth Freemasons Hospital ( Site 1609), Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital ( Site 1604), Nedlands, Western Australia, Australia
Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 3301), Graz, Steiermark, Austria
Medizinische Universitat Innsbruck ( Site 3302), Innsbruck, Tirol, Austria
Medizinische Universitat Wien ( Site 3300), Vienna, Wien, Austria
UZA University Hospital Antwerp ( Site 3204), Edegem, Antwerpen, Belgium
UZ Leuven ( Site 3200), Leuven, Antwerpen, Belgium
Cliniques Universitaires Saint-Luc ( Site 3203), Brussels, Bruxelles-Capitale, Region De, Belgium
AZ Maria Middelares Gent ( Site 3202), Gent, Oost-Vlaanderen, Belgium
AZ Delta ( Site 3206), Roeselare, West-Vlaanderen, Belgium
Instituto do Cancer do Ceara ( Site 2703), Fortaleza, Ceara, Brazil
Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2702), Goiania, Goias, Brazil
Faculdade de Medicina da Universidade Federal de Minas Gerais ( Site 2708), Belo Horizonte, Minas Gerais, Brazil
Hospital de Caridade de Ijui ( Site 2712), Ijui, Rio Grande Do Sul, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 2701), Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Base de Sao Jose de Rio Preto ( Site 2704), Sao Jose do Rio Preto, Sao Paulo, Brazil
Instituto Nacional do Cancer II ( Site 2707), Rio de Janeiro, , Brazil
Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706), Sao Paulo, , Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2713), Sao Paulo, , Brazil
A.C. Camargo Cancer Center ( Site 2705), Sao Paulo, , Brazil
Cross Cancer Institute ( Site 0408), Edmonton, Alberta, Canada
BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0402), Kelowna, British Columbia, Canada
BC Cancer-Vancouver Center ( Site 0412), Vancouver, British Columbia, Canada
Juravinski Cancer Centre ( Site 0406), Hamilton, Ontario, Canada
Kingston Health Sciences Centre ( Site 0401), Kingston, Ontario, Canada
The Credit Valley Hospital ( Site 0403), Mississauga, Ontario, Canada
Sunnybrook Research Institute ( Site 0410), Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0409), Toronto, Ontario, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0414), Montreal, Quebec, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0411), Montreal, Quebec, Canada
McGill University Health Centre ( Site 0404), Montreal, Quebec, Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0417), Sherbrooke, Quebec, Canada
Anhui Provincial Cancer Hospital ( Site 2509), Hefei, Anhui, China
Beijing Obstetrics and Gynecology Hospital Capital Medical University ( Site 2505), Beijing, Beijing, China
Peking Union Medical College Hospital ( Site 2501), Beijing, Beijing, China
Beijing Cancer Hospital ( Site 2504), Beijing, Beijing, China
Chongqing Cancer Hospital ( Site 2513), Chongqing, Chongqing, China
The First Affiliated Hospital.Sun Yat-sen University ( Site 2507), Guangzhou, Guangdong, China
Guang Xi Tumour Hospital, Department of Chemotherapy ( Site 2517), Nanning, Guangxi, China
Hubei Cancer Hospital ( Site 2510), Wuhan, Hubei, China
Xiangya Hospital Central-South University ( Site 2512), Changsha, Hunan, China
Nanjing Maternity and Child Health Care Hospital ( Site 2508), Nanjing, Jiangsu, China
The first affiliated Hospital of Xi an Jiaotong University ( Site 2502), XI An, Shaanxi, China
Fudan University Shanghai Cancer Center ( Site 2500), Shanghai, Shanghai, China
Obstetrics and Gynecology Hosp. Fudan University ( Site 2503), Shanghai, Shanghai, China
The First Affiliated Hospital of Xinjiang Medical University ( Site 2515), Urumqi, Xinjiang, China
Women s Hospital School of Medicine Zhejiang University ( Site 2511), Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 2506), Hangzhou, Zhejiang, China
Universitaetsmedizin Mannheim. Klinik fuer Kinder und Jugendmedizin ( Site 0622), Mannheim, Baden-Wurttemberg, Germany
Universitaetsklinikum Muenster ( Site 0615), Muenster, Baden-Wurttemberg, Germany
Caritas-Krankenhaus St. Josef Regensburg ( Site 0613), Regensburg, Bayern, Germany
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0623), Wiesbaden, Hessen, Germany
Universitaetsklinikum Essen ( Site 0616), Essen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Jena ( Site 0612), Jena, Thuringen, Germany
Charite Universitaetsmedizin Berlin ( Site 0609), Berlin, , Germany
Cork University Hospital ( Site 1400), Cork, , Ireland
St James Hospital ( Site 1401), Dublin, , Ireland
Meir Medical Center ( Site 0702), Kfar-Saba, Central, Israel
Edith Wolfson Medical Center ( Site 0703), Holon, Tell Abib, Israel
Rambam Medical Center ( Site 0700), Haifa, , Israel
Chaim Sheba Medical Center ( Site 0707), Ramat Gan, , Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0800), Meldola, Emilia-Romagna, Italy
Policlinico Universitario Agostino Gemelli ( Site 0805), Rome, Roma, Italy
Ospedale dell Angelo ( Site 0810), Mestre, Venezia, Italy
Medical Oncology Ospedale San Donato ( Site 0812), Arezzo, , Italy
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0801), Bari, , Italy
Ospedale Policlinico S. Orsola-Malpighi ( Site 0803), Bologna, , Italy
Ospedale Antonio Perrino ( Site 0806), Brindisi, , Italy
Azienda Ospedaliera per l Emergenza Cannizzaro ( Site 0807), Catania, , Italy
Istituto Nazionale Tumori Fondazione Pascale ( Site 0808), Napoli, , Italy
Ehime University Hospital ( Site 2413), Toon, Ehime, Japan
Kurume University Hospital ( Site 2403), Kurume, Fukuoka, Japan
Gunma Prefectural Cancer Center ( Site 2404), Ota, Gunma, Japan
National Hospital Organization Hokkaido Cancer Center ( Site 2408), Sapporo, Hokkaido, Japan
Hyogo Cancer Center ( Site 2414), Akashi, Hyogo, Japan
Nippon Medical School Musashi Kosugi Hospital ( Site 2417), Kawasaki, Kanagawa, Japan
St. Marianna University School of Medicine Hospital ( Site 2416), Kawasaki, Kanagawa, Japan
University of the Ryukyus Hospital ( Site 2412), Nakagami-gun, Okinawa, Japan
Saitama Medical University International Medical Center ( Site 2410), Hidaka, Saitama, Japan
Saitama Cancer Center ( Site 2406), Kitaadachi-gun, Saitama, Japan
National Defense Medical College Hospital ( Site 2418), Tokorozawa, Saitama, Japan
Kyorin University Hospital ( Site 2402), Mitaka, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center ( Site 2405), Fukuoka, , Japan
Niigata Cancer Center Hospital ( Site 2415), Niigata, , Japan
Osaka International Cancer Institute ( Site 2409), Osaka, , Japan
The Cancer Institute Hospital of JFCR ( Site 2401), Tokyo, , Japan
Showa University Hospital ( Site 2419), Tokyo, , Japan
Keio University Hospital ( Site 2411), Tokyo, , Japan
Seoul National University Bundang Hospital ( Site 1802), Seongnam-si, Kyonggi-do, Korea, Republic of
Seoul National University Hospital ( Site 1801), Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 1804), Seoul, , Korea, Republic of
Asan Medical Center ( Site 1800), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 1803), Seoul, , Korea, Republic of
Hospital San Lucas Cardiologica del Sureste ( Site 3103), Tuxtla Gutierrez, Chiapas, Mexico
I CAN Oncology SA de SV ( Site 3102), Monterrey, Nuevo Leon, Mexico
Centro Estatal de Cancerologia de Chihuahua ( Site 3101), Chihuahua, , Mexico
Consultorio Dentro de la Torre Medica Dalinde Oncologia Medica ( Site 3108), Ciudad de Mexico, , Mexico
Centro de Investigacion Clinica Gramel ( Site 3107), Mexico City, , Mexico
Centro Oncologico Internacional. SEDNA ( Site 3106), Mexico City, , Mexico
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1008), Lublin, Dolnoslaskie, Poland
Instytut Centrum Zdrowia Matki Polki ( Site 1020), Lodz, Lodzkie, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1019), Krakow, Malopolskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1009), Warsaw, Mazowieckie, Poland
Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 1011), Warszawa, Mazowieckie, Poland
Bialostockie Centrum Onkologii ( Site 1005), Bialystok, Podlaskie, Poland
Centrum Onkologii Instytut im. MSC Oddział w Gliwicach ( Site 1017), Gliwice, Slaskie, Poland
Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 1004), Poznan, Wielkopolskie, Poland
Krasnoyarsk Regional Clinical oncology dispensary ( Site 1118), Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation
Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1100), Moscow, Moskva, Russian Federation
FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 1102), Moscow, Moskva, Russian Federation
Medical Rehabilitation Center ( Site 1101), Moscow, Moskva, Russian Federation
Samara Regional Clinical Oncology Center ( Site 1117), Samara, Samarskaya Oblast, Russian Federation
St.Petersburg Clinical Hospital RAS ( Site 1124), Saint Petersburg, Sankt-Peterburg, Russian Federation
SPb SBHI City Clinical Oncological Dispensary ( Site 1104), Saint Petersburg, Sankt-Peterburg, Russian Federation
Railway Hospital of OJSC ( Site 1122), Saint-Petersburg, Sankt-Peterburg, Russian Federation
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1103), Saint-Petersburg, Sankt-Peterburg, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1108), Kazan, Tatarstan, Respublika, Russian Federation
Siberian State Medical University ( Site 1121), Tomsk, Tomskaya Oblast, Russian Federation
Institut Catala d Oncologia Badalona ( Site 1201), Badalona, Barcelona, Spain
Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1202), A Coruna, La Coruna, Spain
Instituto Valenciano de Oncologia - IVO ( Site 1205), Valencia, Valenciana, Comunitat, Spain
Hospital General Universitario de Valencia ( Site 1203), Valencia, Valenciana, Comunitat, Spain
Parc de Salut Mar ( Site 1200), Barcelona, , Spain
Hospital Universitario Reina Sofia ( Site 1207), Cordoba, , Spain
Hospital Clinico San Carlos ( Site 1209), Madrid, , Spain
Hospital Materno Infantil [Malaga, Spain] ( Site 1208), Malaga, , Spain
China Medical University Hospital ( Site 1903), Taichung, , Taiwan
Taichung Veterans General Hospital ( Site 1902), Taichung, , Taiwan
National Taiwan University Hospital ( Site 1904), Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 1900), Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital ( Site 1901), Taoyuan, , Taiwan
Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi ( Site 1303), Adana, , Turkey
Cukurova Uni. Tip Fakultesi ( Site 1302), Adana, , Turkey
Gazi Universitesi Tip Fakultesi ( Site 1308), Ankara, , Turkey
Baskent Universitesi Ankara Hastanesi ( Site 1300), Ankara, , Turkey
Akdeniz Universitesi Tıp Fakultesi ( Site 1301), Antalya, , Turkey
Uludag Universitesi Tip Fakultesi ( Site 1307), Bursa, , Turkey
Clinical oncology dispensary of Dnipro ( Site 1512), Dnipro, Dnipropetrovska Oblast, Ukraine
City Clinical Hosp.4 of DCC ( Site 1501), Dnipro, Dnipropetrovska Oblast, Ukraine
MI Precarpathian Clinical Oncology Center ( Site 1503), Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 1511), Kharkiv, Kharkivska Oblast, Ukraine
Communal non profit enterprise Regional Clinical Oncology Center ( Site 1509), Kharkiv, Kharkivska Oblast, Ukraine
Khmelnitskiy Regional Onkology Dispensary ( Site 1513), Khmelnitskiy, Khmelnytska Oblast, Ukraine
Medical Center Asklepion LLC ( Site 1514), Khodosivka, Kyivska Oblast, Ukraine
National Cancer Institute of the MoH of Ukraine ( Site 1510), Kyiv, Kyivska Oblast, Ukraine
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 1507), Kyiv, Kyivska Oblast, Ukraine
MI Odessa Regional Oncological Centre ( Site 1504), Odesa, Odeska Oblast, Ukraine
Kyiv City Clinical Oncology Centre ( Site 1505), Kyiv, , Ukraine
Western General Hospital ( Site 1411), Edinburgh, Edinburgh, City Of, United Kingdom
UCLH NHS Foundation Trust ( Site 1405), London, London, City Of, United Kingdom
Mount Vernon Cancer Centre ( Site 1409), Northwood, London, City Of, United Kingdom
Churchill Hospital ( Site 1406), Oxford, Oxfordshire, United Kingdom
The James Cook University Hospital ( Site 1403), Middlesbrough, , United Kingdom
Northern Centre for Cancer Care ( Site 1408), Newcastle Upon Tyne, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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