Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) (LEAP-001)

March 1, 2024 updated by: Merck Sharp & Dohme LLC

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

842

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1118AAT
        • Hospital Aleman ( Site 2600)
      • Buenos Aires, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires ( Site 2603)
      • La Rioja, Argentina, 5300
        • Centro Oncologico Riojano Integral ( Site 2605)
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1012AAR
        • IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2607)
      • La Plata, Buenos Aires, Argentina, B1900AXI
        • Hospital Italiano de La Plata ( Site 2601)
      • Mar del Plata, Buenos Aires, Argentina, B7600FZO
        • Instituto de Investigaciones Clinicas Mar del Plata ( Site 2606)
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris OBrien Lifehouse ( Site 1605)
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital [Australia] ( Site 1603)
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital ( Site 1600)
      • Westmead, New South Wales, Australia, 2145
        • The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 1602)
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Mater Misericordiae Ltd ( Site 1608)
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health ( Site 1606)
      • Melbourne, Victoria, Australia, 3002
        • Epworth Freemasons Hospital ( Site 1609)
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital ( Site 1604)
  • Austria
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 3301)
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Medizinische Universitat Innsbruck ( Site 3302)
    • Wien
      • Vienna, Wien, Austria, 1090
        • Medizinische Universitat Wien ( Site 3300)
  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • UZA University Hospital Antwerp ( Site 3204)
      • Leuven, Antwerpen, Belgium, 3000
        • UZ Leuven ( Site 3200)
    • Bruxelles-Capitale, Region De
      • Brussels, Bruxelles-Capitale, Region De, Belgium, 1200
        • Cliniques Universitaires Saint-Luc ( Site 3203)
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • AZ Maria Middelares Gent ( Site 3202)
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • AZ Delta ( Site 3206)
  • Brazil
      • Rio de Janeiro, Brazil, 20220-410
        • Instituto Nacional do Cancer II ( Site 2707)
      • Sao Paulo, Brazil, 01317-001
        • Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706)
      • Sao Paulo, Brazil, 01321-001
        • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2713)
      • Sao Paulo, Brazil, 01509-900
        • A.C. Camargo Cancer Center ( Site 2705)
    • Ceara
      • Fortaleza, Ceara, Brazil, 60430-230
        • Instituto do Cancer do Ceara ( Site 2703)
    • Goias
      • Goiania, Goias, Brazil, 74605-070
        • Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2702)
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100
        • Faculdade de Medicina da Universidade Federal de Minas Gerais ( Site 2708)
    • Rio Grande Do Sul
      • Ijui, Rio Grande Do Sul, Brazil, 98700-000
        • Hospital de Caridade de Ijui ( Site 2712)
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 2701)
    • Sao Paulo
      • Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000
        • Hospital de Base de Sao Jose de Rio Preto ( Site 2704)
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute ( Site 0408)
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0402)
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer-Vancouver Center ( Site 0412)
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Juravinski Cancer Centre ( Site 0406)
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre ( Site 0401)
      • Mississauga, Ontario, Canada, L5M 2N1
        • The Credit Valley Hospital ( Site 0403)
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Research Institute ( Site 0410)
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre ( Site 0409)
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0414)
      • Montreal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0411)
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre ( Site 0404)
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0417)
  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Cancer Hospital ( Site 2509)
    • Beijing
      • Beijing, Beijing, China, 100032
        • Beijing Obstetrics and Gynecology Hospital Capital Medical University ( Site 2505)
      • Beijing, Beijing, China, 100032
        • Peking Union Medical College Hospital ( Site 2501)
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital ( Site 2504)
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Chongqing Cancer Hospital ( Site 2513)
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital.Sun Yat-sen University ( Site 2507)
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Guang Xi Tumour Hospital, Department of Chemotherapy ( Site 2517)
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital ( Site 2510)
    • Hunan
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital Central-South University ( Site 2512)
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • Nanjing Maternity and Child Health Care Hospital ( Site 2508)
    • Shaanxi
      • XI An, Shaanxi, China, 710061
        • The first affiliated Hospital of Xi an Jiaotong University ( Site 2502)
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center ( Site 2500)
      • Shanghai, Shanghai, China, 200090
        • Obstetrics and Gynecology Hosp. Fudan University ( Site 2503)
    • Xinjiang
      • Urumqi, Xinjiang, China, 830054
        • The First Affiliated Hospital of Xinjiang Medical University ( Site 2515)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Women s Hospital School of Medicine Zhejiang University ( Site 2511)
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital ( Site 2506)
  • Germany
      • Berlin, Germany, 13353
        • Charite Universitaetsmedizin Berlin ( Site 0609)
    • Baden-Wurttemberg
      • Mannheim, Baden-Wurttemberg, Germany, 68167
        • Universitaetsmedizin Mannheim. Klinik fuer Kinder und Jugendmedizin ( Site 0622)
      • Muenster, Baden-Wurttemberg, Germany, 48149
        • Universitaetsklinikum Muenster ( Site 0615)
    • Bayern
      • Regensburg, Bayern, Germany, 93053
        • Caritas-Krankenhaus St. Josef Regensburg ( Site 0613)
    • Hessen
      • Wiesbaden, Hessen, Germany, 65199
        • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0623)
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45147
        • Universitaetsklinikum Essen ( Site 0616)
    • Thuringen
      • Jena, Thuringen, Germany, 07747
        • Universitaetsklinikum Jena ( Site 0612)
  • Ireland
      • Cork, Ireland, T12 YE02
        • Cork University Hospital ( Site 1400)
      • Dublin, Ireland, Dublin 8
        • St James Hospital ( Site 1401)
  • Israel
      • Haifa, Israel, 3525408
        • Rambam Medical Center ( Site 0700)
      • Ramat Gan, Israel, 5262000
        • Chaim Sheba Medical Center ( Site 0707)
    • Central
      • Kfar-Saba, Central, Israel, 4428132
        • Meir Medical Center ( Site 0702)
    • Tell Abib
      • Holon, Tell Abib, Israel, 5822012
        • Edith Wolfson Medical Center ( Site 0703)
  • Italy
      • Arezzo, Italy, 52100
        • Medical Oncology Ospedale San Donato ( Site 0812)
      • Bari, Italy, 70124
        • IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0801)
      • Bologna, Italy, 40138
        • Ospedale Policlinico S. Orsola-Malpighi ( Site 0803)
      • Brindisi, Italy, 72100
        • Ospedale Antonio Perrino ( Site 0806)
      • Catania, Italy, 95126
        • Azienda Ospedaliera per l Emergenza Cannizzaro ( Site 0807)
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori Fondazione Pascale ( Site 0808)
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0800)
    • Roma
      • Rome, Roma, Italy, 00168
        • Policlinico Universitario Agostino Gemelli ( Site 0805)
    • Venezia
      • Mestre, Venezia, Italy, 30174
        • Ospedale dell Angelo ( Site 0810)
  • Japan
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center ( Site 2405)
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital ( Site 2415)
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute ( Site 2409)
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR ( Site 2401)
      • Tokyo, Japan, 142-8666
        • Showa University Hospital ( Site 2419)
      • Tokyo, Japan, 160-8582
        • Keio University Hospital ( Site 2411)
    • Ehime
      • Toon, Ehime, Japan, 791-0295
        • Ehime University Hospital ( Site 2413)
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Kurume University Hospital ( Site 2403)
    • Gunma
      • Ota, Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center ( Site 2404)
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center ( Site 2408)
    • Hyogo
      • Akashi, Hyogo, Japan, 673-8558
        • Hyogo Cancer Center ( Site 2414)
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 211-8533
        • Nippon Medical School Musashi Kosugi Hospital ( Site 2417)
      • Kawasaki, Kanagawa, Japan, 216-8511
        • St. Marianna University School of Medicine Hospital ( Site 2416)
    • Okinawa
      • Nakagami-gun, Okinawa, Japan, 903-0215
        • University of the Ryukyus Hospital ( Site 2412)
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center ( Site 2410)
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Saitama Cancer Center ( Site 2406)
      • Tokorozawa, Saitama, Japan, 359-8513
        • National Defense Medical College Hospital ( Site 2418)
    • Tokyo
      • Mitaka, Tokyo, Japan, 181-8611
        • Kyorin University Hospital ( Site 2402)
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital ( Site 1801)
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital Yonsei University Health System ( Site 1804)
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center ( Site 1800)
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center ( Site 1803)
    • Kyonggi-do
      • Seongnam-si, Kyonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital ( Site 1802)
  • Mexico
      • Chihuahua, Mexico, 31000
        • Centro Estatal de Cancerologia de Chihuahua ( Site 3101)
      • Ciudad de Mexico, Mexico, 06760
        • Consultorio Dentro de la Torre Medica Dalinde Oncologia Medica ( Site 3108)
      • Mexico City, Mexico, 03720
        • Centro de Investigacion Clinica Gramel ( Site 3107)
      • Mexico City, Mexico, 04700
        • Centro Oncologico Internacional. SEDNA ( Site 3106)
    • Chiapas
      • Tuxtla Gutierrez, Chiapas, Mexico, 29090
        • Hospital San Lucas Cardiologica del Sureste ( Site 3103)
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64710
        • I CAN Oncology SA de SV ( Site 3102)
  • Poland
    • Dolnoslaskie
      • Lublin, Dolnoslaskie, Poland, 20-081
        • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1008)
    • Lodzkie
      • Lodz, Lodzkie, Poland, 93-338
        • Instytut Centrum Zdrowia Matki Polki ( Site 1020)
    • Malopolskie
      • Krakow, Malopolskie, Poland, 31-826
        • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1019)
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1009)
      • Warszawa, Mazowieckie, Poland, 00-315
        • Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 1011)
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-027
        • Bialostockie Centrum Onkologii ( Site 1005)
    • Slaskie
      • Gliwice, Slaskie, Poland, 44-102
        • Centrum Onkologii Instytut im. MSC Oddział w Gliwicach ( Site 1017)
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 61-866
        • Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 1004)
  • Russian Federation
    • Krasnoyarskiy Kray
      • Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation, 660133
        • Krasnoyarsk Regional Clinical oncology dispensary ( Site 1118)
    • Moskva
      • Moscow, Moskva, Russian Federation, 115478
        • Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1100)
      • Moscow, Moskva, Russian Federation, 115682
        • FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 1102)
      • Moscow, Moskva, Russian Federation, 125367
        • Medical Rehabilitation Center ( Site 1101)
    • Samarskaya Oblast
      • Samara, Samarskaya Oblast, Russian Federation, 443031
        • Samara Regional Clinical Oncology Center ( Site 1117)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 194017
        • St.Petersburg Clinical Hospital RAS ( Site 1124)
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 198255
        • SPb SBHI City Clinical Oncological Dispensary ( Site 1104)
      • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 195271
        • Railway Hospital of OJSC ( Site 1122)
      • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 197758
        • National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1103)
    • Tatarstan, Respublika
      • Kazan, Tatarstan, Respublika, Russian Federation, 420029
        • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1108)
    • Tomskaya Oblast
      • Tomsk, Tomskaya Oblast, Russian Federation, 634028
        • Siberian State Medical University ( Site 1121)
  • Spain
      • Barcelona, Spain, 08003
        • Parc de Salut Mar ( Site 1200)
      • Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia ( Site 1207)
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos ( Site 1209)
      • Malaga, Spain, 29011
        • Hospital Materno Infantil [Malaga, Spain] ( Site 1208)
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Institut Catala d Oncologia Badalona ( Site 1201)
    • La Coruna
      • A Coruna, La Coruna, Spain, 15006
        • Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1202)
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46009
        • Instituto Valenciano de Oncologia - IVO ( Site 1205)
      • Valencia, Valenciana, Comunitat, Spain, 46014
        • Hospital General Universitario de Valencia ( Site 1203)
  • Taiwan
      • Taichung, Taiwan, 404
        • China Medical University Hospital ( Site 1903)
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital ( Site 1902)
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital ( Site 1904)
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital ( Site 1900)
      • Taoyuan, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital ( Site 1901)
  • Turkey
      • Adana, Turkey, 01120
        • Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi ( Site 1303)
      • Adana, Turkey, 01330
        • Cukurova Uni. Tip Fakultesi ( Site 1302)
      • Ankara, Turkey, 05600
        • Gazi Universitesi Tip Fakultesi ( Site 1308)
      • Ankara, Turkey, 06490
        • Baskent Universitesi Ankara Hastanesi ( Site 1300)
      • Antalya, Turkey, 07070
        • Akdeniz Universitesi Tıp Fakultesi ( Site 1301)
      • Bursa, Turkey, 16059
        • Uludag Universitesi Tip Fakultesi ( Site 1307)
  • Ukraine
      • Kyiv, Ukraine, 03115
        • Kyiv City Clinical Oncology Centre ( Site 1505)
    • Dnipropetrovska Oblast
      • Dnipro, Dnipropetrovska Oblast, Ukraine, 49055
        • Clinical oncology dispensary of Dnipro ( Site 1512)
      • Dnipro, Dnipropetrovska Oblast, Ukraine, 49102
        • City Clinical Hosp.4 of DCC ( Site 1501)
    • Ivano-Frankivska Oblast
      • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76018
        • MI Precarpathian Clinical Oncology Center ( Site 1503)
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61024
        • Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 1511)
      • Kharkiv, Kharkivska Oblast, Ukraine, 61070
        • Communal non profit enterprise Regional Clinical Oncology Center ( Site 1509)
    • Khmelnytska Oblast
      • Khmelnitskiy, Khmelnytska Oblast, Ukraine, 29009
        • Khmelnitskiy Regional Onkology Dispensary ( Site 1513)
    • Kyivska Oblast
      • Khodosivka, Kyivska Oblast, Ukraine, 08173
        • Medical Center Asklepion LLC ( Site 1514)
      • Kyiv, Kyivska Oblast, Ukraine, 03022
        • National Cancer Institute of the MoH of Ukraine ( Site 1510)
      • Kyiv, Kyivska Oblast, Ukraine, 03126
        • Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 1507)
    • Odeska Oblast
      • Odesa, Odeska Oblast, Ukraine, 65055
        • MI Odessa Regional Oncological Centre ( Site 1504)
  • United Kingdom
      • Middlesbrough, United Kingdom, TS4 3BW
        • The James Cook University Hospital ( Site 1403)
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Northern Centre for Cancer Care ( Site 1408)
    • Edinburgh, City Of
      • Edinburgh, Edinburgh, City Of, United Kingdom, EH4 2XU
        • Western General Hospital ( Site 1411)
    • London, City Of
      • London, London, City Of, United Kingdom, NW1 2PG
        • UCLH NHS Foundation Trust ( Site 1405)
      • Northwood, London, City Of, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre ( Site 1409)
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Churchill Hospital ( Site 1406)
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • University of South Alabama, Mitchell Cancer Institute ( Site 0245)
    • Arizona
      • Tucson, Arizona, United States, 85711
        • Arizona Oncology Associates PC- HOPE ( Site 8005)
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Hematology and Oncology Clinic (Westwood) ( Site 0233)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center ( Site 0204)
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Smilow Cancer Hospital at Yale New Haven ( Site 0202)
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Health System ( Site 0249)
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Cancer Center at Augusta University ( Site 0222)
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Women's Cancer Care ( Site 0208)
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Medical Partners ( Site 0217)
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Hematology, PA ( Site 8003)
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 0268)
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0226)
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0273)
      • Montvale, New Jersey, United States, 07645
        • MSKCC-Bergen ( Site 0276)
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Medical Center ( Site 0235)
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan-Kettering Cancer Center at Commack ( Site 0267)
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Cancer Center - West Harrison ( Site 0274)
      • New York, New York, United States, 10011
        • The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0206)
      • New York, New York, United States, 10022
        • Memorial Sloan Kettering Cancer Center ( Site 0246)
      • Rochester, New York, United States, 14642
        • University of Rochester ( Site 0238)
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Cancer Center - Nassau ( Site 0275)
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina- Chapel Hill ( Site 0254)
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Roger Maris Cancer Center ( Site 0277)
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Willamette Valley Cancer Institute and Research Center ( Site 8004)
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center Oncology Clinic ( Site 0205)
    • Texas
      • Dallas, Texas, United States, 75235
        • Parkland Health & Hospital System ( Site 0272)
      • Dallas, Texas, United States, 75390-9015
        • University of Texas Southwestern Medical Center ( Site 0264)
      • The Woodlands, Texas, United States, 77380
        • Texas Oncology-The Woodlands ( Site 8000)
    • Washington
      • Vancouver, Washington, United States, 98686
        • Legacy Salmon Creek Medical Center ( Site 0253)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has Stage III, Stage IV, or recurrent, histologically-confirmed endometrial carcinoma with disease that is either measurable or nonmeasurable but radiographically apparent, per RECIST 1.1 as assessed by BICR (note: may have received prior chemotherapy only if administered concurrently with radiation; may have received prior radiation without concurrent chemotherapy; may have received prior hormonal therapy for treatment of endometrial carcinoma, provided that it was discontinued ≥1 week prior to randomization; and may have received 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy)
  • Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion that was not previously irradiated, for determination of mismatch repair (MMR) status
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to the first dose of study intervention
  • Is not pregnant or breastfeeding, and is either not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees to use contraception during the study and for ≥120 days after pembrolizumab, ≥30 days after lenvatinib, or ≥180 days after (chemotherapy) [if a WOCBP, a pregnancy test will be required within 24 hours of first dose of study drug]
  • Has adequately controlled blood pressure within 7 days prior to randomization
  • Has adequate organ function based on assessment within 7 days prior to the first dose of study intervention

Exclusion Criteria:

  • Has carcinosarcoma (malignant mixed Műllerian tumor), endometrial leiomyosarcoma or other high grade sarcomas, or endometrial stromal sarcomas
  • Has a central nervous system (CNS) metastasis, unless local therapy (e.g., whole brain radiation therapy, surgery, or radiosurgery) has been completed and have discontinued use of corticosteroids for this indication for ≥4 weeks prior to starting study medication (major surgery within 3 weeks of the first dose of study drug will be exclusionary)
  • Has a known additional malignancy (other than endometrial carcinoma) that is progressing or has required active treatment in the last 3 years
  • Has gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib
  • Has a pre-existing Grade ≥3 gastrointestinal or nongastrointestinal fistula
  • Has radiographic evidence of major blood vessel invasion/infiltration
  • Has active hemoptysis (bright red blood at ≥0.5 teaspoon) within 3 weeks prior to the first dose of study intervention or tumor bleeding within 2 weeks prior to randomization
  • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction or cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
  • Has any infection requiring systemic treatment
  • Has not recovered adequately from any toxicity and/or complications from major surgery prior to randomization
  • Has a known history of human immunodeficiency virus (HIV) infection (HIV test is required at screening)
  • Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV) [defined as HCV ribonucleic acid (RNA) is detected] (hepatitis B and C testing is required at screening only when mandated by local health authority)
  • Has a history of (noninfectious) pneumonitis that required treatment with steroids, or has current pneumonitis
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study
  • 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 to randomization
  • Has an active autoimmune disease (with the exception of psoriasis) that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
  • Has received prior systemic chemotherapy in any setting for the treatment of endometrial carcinoma (note: prior chemotherapy administered concurrently with radiation is permitted)
  • Has received prior radiotherapy within 4 weeks prior to randomization (participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis - a 2-week washout is permitted for palliative radiation to non-CNS disease and vaginal brachytherapy)
  • Has received prior hormonal therapy for the treatment of endometrial carcinoma within 1 week of randomization
  • Has received prior therapy with any treatment targeting vascular endothelial growth factor (VEGF)-directed angiogenesis, an anti-programmed cell death (PD)-1, anti-PD ligand (L)1, or anti-PD L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)
  • Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention
  • Has known intolerance to study intervention (or any of the excipients)
  • Has had an allogenic tissue/solid organ transplant
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lenvatinib + Pembrolizumab
Participants receive lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
Drug: Lenvatinib
Lenvatinib 4 mg or 10 mg capsules at a total daily dose of 20 mg taken by mouth once per day.
Other Names:
  • E7080, MK-7902, LENVIMA®
Biological: Pembrolizumab
Pembrolizumab 200 mg IV infusion given on Day 1 of each cycle.
Other Names:
  • MK-3475, KEYTRUDA®
Active Comparator: Paclitaxel + Carboplatin
Participants receive paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
Drug: Paclitaxel
Paclitaxel 175 mg/m^2 IV infusion given on Day 1 of each cycle.
Other Names:
  • TAXOL®, ONXAL®
Drug: Carboplatin
Carboplatin 10 mg/mL IV infusion at a total dose of are-under-the-curve (AUC) 6 (per Calvert's formula) given on Day 1 of each cycle.
Other Names:
  • PARAPLATIN®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR)
Time Frame: Up to approximately 31 months
Progression-free survival based on RECIST 1.1 as assessed by BICR. Progression-free survival is measured from the time of randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Up to approximately 31 months
Overall Survival (OS)
Time Frame: Up to approximately 45 months
Overall survival is measured from the time of randomization up to death due to any cause.
Up to approximately 45 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR ) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent review (BICR)
Time Frame: Up to approximately 31 months
The ORR (either confirmed complete response [CR] or partial response [PR]) based on RECIST 1.1 and assessed by BICR will be determined in mismatch repair proficient (pMMR) participants and in all-comer participants who have measurable disease at study entry.
Up to approximately 31 months
Mean change from baseline in the global health status/quality of life score of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) in pMMR and in all-comer participants
Time Frame: Baseline and designated time points up to 27 months
The EORTC QLQ-C30 was developed to assess the quality of life of patients with cancer. It contains 30 questions (items), 24 of which aggregate into nine multi-item scales representing various aspects, or dimensions, of quality of life (QoL): one global scale, five functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea, pain), and six additional single-symptom items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Individual items are scored on a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Raw scores for each scale are standardized into a range of 0 to 100 by linear transformation; a higher score on the global and functional scales represents a higher ("better") level of functioning, and a higher score on the symptom scale represents a higher ("worse") level of symptoms.
Baseline and designated time points up to 27 months
Percentage of participants experiencing an adverse event (AE)
Time Frame: Up to approximately 27 months (through 90 days after the last dose of study treatment)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 27 months (through 90 days after the last dose of study treatment)
Percentage of participants experiencing a serious adverse event (SAE)
Time Frame: Up to approximately 28 months (through 120 days after the last dose of study treatment)
An SAE is an AE that results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability, is a congenital birth defect, or is another important medical event.
Up to approximately 28 months (through 120 days after the last dose of study treatment)
Percentage of participants experiencing an immune-related AE (irAE)
Time Frame: Up to approximately 27 months (through 90 days after the last dose of study treatment)
Immune-related AEs will be monitored in both arms.
Up to approximately 27 months (through 90 days after the last dose of study treatment)
Percentage of participants discontinuing from study treatment due to an AE(s)
Time Frame: Up to approximately 24 months (through the last dose of study treatment)
Discontinuations related to AEs will be monitored in both arms.
Up to approximately 24 months (through the last dose of study treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Eisai Inc.

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2019

Primary Completion (Actual)

October 2, 2023

Study Completion (Estimated)

April 10, 2025

Study Registration Dates

First Submitted

March 19, 2019

First Submitted That Met QC Criteria

March 19, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7902-001
  • MK-7902-001 (Other Identifier: Merck)
  • ENGOT-en9 (Other Identifier: European Network for Gynaecological Oncological Trial groups)
  • 194710 (Registry Identifier: JAPIC-CTI)
  • 2018-003009-24 (EudraCT Number)
  • 2023-505614-17 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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