AzTrials
AzTrials

Endometrial NeoplasmsPhase 3LEAP-001NCT03884101

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

A Phase 3 study testing Lenvatinib, Pembrolizumab and Paclitaxel in people with Endometrial Neoplasms, run by Merck Sharp & Dohme LLC at 195 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Neoplasms
What is being tested?
Lenvatinib, Pembrolizumab and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
842 participants
Where
195 sitesin 22 countries
Study dates
11 Apr 2019to 5 Feb 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has Stage III, Stage IV, or recurrent, histologically-confirmed endometrial carcinoma with disease that is either measurable or nonmeasurable but radiographically apparent, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (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

Who cannot join

  • 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
Show all 25Show fewer
  • 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

Trial locations and contacts

195 sites in 22 countries.

195 sites in 22 countries

United States29 sites

  • Georgia Cancer Center at Augusta University ( Site 0222)

    Augusta, Georgia, 30912

  • University of Colorado Cancer Center ( Site 0204)

    Aurora, Colorado, 80045

  • Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 0268)

    Basking Ridge, New Jersey, 07920

  • University of North Carolina- Chapel Hill ( Site 0254)

    Chapel Hill, North Carolina, 27599

  • Memorial Sloan-Kettering Cancer Center at Commack ( Site 0267)

    Commack, New York, 11725

  • Women's Cancer Care ( Site 0208)

    Covington, Louisiana, 70433

  • Parkland Health & Hospital System ( Site 0272)

    Dallas, Texas, 75235

  • University of Texas Southwestern Medical Center ( Site 0264)

    Dallas, Texas, 75390-9015

  • Willamette Valley Cancer Institute and Research Center ( Site 8004)

    Eugene, Oregon, 97401

  • Roger Maris Cancer Center ( Site 0277)

    Fargo, North Dakota, 58102

  • John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0226)

    Hackensack, New Jersey, 07601

  • Memorial Sloan Kettering Cancer Center - West Harrison ( Site 0274)

    Harrison, New York, 10604

  • UCLA Hematology and Oncology Clinic (Westwood) ( Site 0233)

    Los Angeles, California, 90095

  • University of Miami Health System ( Site 0249)

    Miami, Florida, 33136

  • Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0273)

    Middletown, New Jersey, 07748

  • Minnesota Oncology Hematology, PA ( Site 8003)

    Minneapolis, Minnesota, 55404

  • University of South Alabama, Mitchell Cancer Institute ( Site 0245)

    Mobile, Alabama, 36604

  • MSKCC-Bergen ( Site 0276)

    Montvale, New Jersey, 07645

  • Smilow Cancer Hospital at Yale New Haven ( Site 0202)

    New Haven, Connecticut, 06511

  • The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0206)

    New York, New York, 10011

  • Memorial Sloan Kettering Cancer Center ( Site 0246)

    New York, New York, 10022

  • University of Rochester ( Site 0238)

    Rochester, New York, 14642

  • Maine Medical Partners ( Site 0217)

    Scarborough, Maine, 04074

  • Sanford Cancer Center Oncology Clinic ( Site 0205)

    Sioux Falls, South Dakota, 57104

  • Holy Name Medical Center ( Site 0235)

    Teaneck, New Jersey, 07666

  • Texas Oncology-The Woodlands ( Site 8000)

    The Woodlands, Texas, 77380

  • Arizona Oncology Associates PC- HOPE ( Site 8005)

    Tucson, Arizona, 85711

  • Memorial Sloan Kettering Cancer Center - Nassau ( Site 0275)

    Uniondale, New York, 11553

  • Legacy Salmon Creek Medical Center ( Site 0253)

    Vancouver, Washington, 98686

Other trials in United States

Japan18 sites

  • Hyogo Cancer Center ( Site 2414)

    Akashi, Hyōgo, 673-8558

  • National Hospital Organization Kyushu Cancer Center ( Site 2405)

    Fukuoka, 811-1395

  • Saitama Medical University International Medical Center ( Site 2410)

    Hidaka, Saitama, 350-1298

  • Nippon Medical School Musashi Kosugi Hospital ( Site 2417)

    Kawasaki, Kanagawa, 211-8533

  • St. Marianna University School of Medicine Hospital ( Site 2416)

    Kawasaki, Kanagawa, 216-8511

  • Saitama Cancer Center ( Site 2406)

    Kitaadachi-gun, Saitama, 362-0806

  • Kurume University Hospital ( Site 2403)

    Kurume, Fukuoka, 830-0011

  • Kyorin University Hospital ( Site 2402)

    Mitaka, Tokyo, 181-8611

  • University of the Ryukyus Hospital ( Site 2412)

    Nakagami-gun, Okinawa, 903-0215

  • Niigata Cancer Center Hospital ( Site 2415)

    Niigata, 951-8566

  • Osaka International Cancer Institute ( Site 2409)

    Osaka, 541-8567

  • Gunma Prefectural Cancer Center ( Site 2404)

    Ōta, Gunma, 373-8550

  • National Hospital Organization Hokkaido Cancer Center ( Site 2408)

    Sapporo, Hokkaido, 003-0804

  • National Defense Medical College Hospital ( Site 2418)

    Tokorozawa, Saitama, 359-8513

  • The Cancer Institute Hospital of JFCR ( Site 2401)

    Tokyo, 135-8550

  • Showa University Hospital ( Site 2419)

    Tokyo, 142-8666

  • Keio University Hospital ( Site 2411)

    Tokyo, 160-8582

  • Ehime University Hospital ( Site 2413)

    Tōon, Ehime, 791-0295

Other trials in Japan

China16 sites

  • Beijing Obstetrics and Gynecology Hospital Capital Medical University ( Site 2505)

    Beijing, Beijing Municipality, 100032

  • Peking Union Medical College Hospital ( Site 2501)

    Beijing, Beijing Municipality, 100032

  • Beijing Cancer Hospital ( Site 2504)

    Beijing, Beijing Municipality, 100142

  • Xiangya Hospital Central-South University ( Site 2512)

    Changsha, Hunan, 410008

  • Chongqing Cancer Hospital ( Site 2513)

    Chongqing, Chongqing Municipality, 400030

  • The First Affiliated Hospital.Sun Yat-sen University ( Site 2507)

    Guangzhou, Guangdong, 510080

  • Women s Hospital School of Medicine Zhejiang University ( Site 2511)

    Hangzhou, Zhejiang, 310006

  • Zhejiang Cancer Hospital ( Site 2506)

    Hangzhou, Zhejiang, 310022

  • Anhui Provincial Cancer Hospital ( Site 2509)

    Hefei, Anhui, 230001

  • Nanjing Maternity and Child Health Care Hospital ( Site 2508)

    Nanjing, Jiangsu, 210011

  • Guang Xi Tumour Hospital, Department of Chemotherapy ( Site 2517)

    Nanning, Guangxi, 530021

  • Fudan University Shanghai Cancer Center ( Site 2500)

    Shanghai, Shanghai Municipality, 200032

  • Obstetrics and Gynecology Hosp. Fudan University ( Site 2503)

    Shanghai, Shanghai Municipality, 200090

  • The First Affiliated Hospital of Xinjiang Medical University ( Site 2515)

    Ürümqi, Xinjiang, 830054

  • Hubei Cancer Hospital ( Site 2510)

    Wuhan, Hubei, 430079

  • The first affiliated Hospital of Xi an Jiaotong University ( Site 2502)

    Xi'an, Shaanxi, 710061

Other trials in China

Canada12 sites

  • Cross Cancer Institute ( Site 0408)

    Edmonton, Alberta, T6G 1Z2

  • Juravinski Cancer Centre ( Site 0406)

    Hamilton, Ontario, L8V 1C3

  • BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0402)

    Kelowna, British Columbia, V1Y 5L3

  • Kingston Health Sciences Centre ( Site 0401)

    Kingston, Ontario, K7L 2V7

  • The Credit Valley Hospital ( Site 0403)

    Mississauga, Ontario, L5M 2N1

  • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0414)

    Montreal, Quebec, H1T 2M4

  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0411)

    Montreal, Quebec, H2X 3E4

  • McGill University Health Centre ( Site 0404)

    Montreal, Quebec, H4A 3J1

  • CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0417)

    Sherbrooke, Quebec, J1H 5N4

  • Sunnybrook Research Institute ( Site 0410)

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre ( Site 0409)

    Toronto, Ontario, M5G 2M9

  • BC Cancer-Vancouver Center ( Site 0412)

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Russia11 sites

  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1108)

    Kazan', Tatarstan, Respublika, 420029

  • Krasnoyarsk Regional Clinical oncology dispensary ( Site 1118)

    Krasnoyarsk, Krasnoyarsk Krai, 660133

  • Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1100)

    Moscow, Moscow, 115478

  • FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 1102)

    Moscow, Moscow, 115682

  • Medical Rehabilitation Center ( Site 1101)

    Moscow, Moscow, 125367

  • St.Petersburg Clinical Hospital RAS ( Site 1124)

    Saint Petersburg, Sankt-Peterburg, 194017

  • Railway Hospital of OJSC ( Site 1122)

    Saint Petersburg, Sankt-Peterburg, 195271

  • National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1103)

    Saint Petersburg, Sankt-Peterburg, 197758

  • SPb SBHI City Clinical Oncological Dispensary ( Site 1104)

    Saint Petersburg, Sankt-Peterburg, 198255

  • Samara Regional Clinical Oncology Center ( Site 1117)

    Samara, Samara Oblast, 443031

  • Siberian State Medical University ( Site 1121)

    Tomsk, Tomsk Oblast, 634028

Other trials in Russia

Ukraine11 sites

  • Clinical oncology dispensary of Dnipro ( Site 1512)

    Dnipro, Dnipropetrovsk Oblast, 49055

  • City Clinical Hosp.4 of DCC ( Site 1501)

    Dnipro, Dnipropetrovsk Oblast, 49102

  • MI Precarpathian Clinical Oncology Center ( Site 1503)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

  • Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 1511)

    Kharkiv, Kharkiv Oblast, 61024

  • Communal non profit enterprise Regional Clinical Oncology Center ( Site 1509)

    Kharkiv, Kharkiv Oblast, 61070

  • Khmelnitskiy Regional Onkology Dispensary ( Site 1513)

    Khmelnitskiy, Khmelnytskyi Oblast, 29009

  • Medical Center Asklepion LLC ( Site 1514)

    Khodosovka, Kyivska Oblast, 08173

  • National Cancer Institute of the MoH of Ukraine ( Site 1510)

    Kyiv, Kyivska Oblast, 03022

  • Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 1507)

    Kyiv, Kyivska Oblast, 03126

  • Kyiv City Clinical Oncology Centre ( Site 1505)

    Kyiv, 03115

  • MI Odessa Regional Oncological Centre ( Site 1504)

    Odesa, Odesa Oblast, 65055

Other trials in Ukraine

Brazil10 sites

  • Faculdade de Medicina da Universidade Federal de Minas Gerais ( Site 2708)

    Belo Horizonte, Minas Gerais, 30130-100

  • Instituto do Cancer do Ceara ( Site 2703)

    Fortaleza, Ceará, 60430-230

  • Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2702)

    Goiânia, Goiás, 74605-070

  • Hospital de Caridade de Ijui ( Site 2712)

    Ijuí, Rio Grande do Sul, 98700-000

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 2701)

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Nacional do Cancer II ( Site 2707)

    Rio de Janeiro, 20220-410

  • Hospital de Base de Sao Jose de Rio Preto ( Site 2704)

    São José do Rio Preto, São Paulo, 15090-000

  • Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706)

    São Paulo, 01317-001

  • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2713)

    São Paulo, 01321-001

  • A.C. Camargo Cancer Center ( Site 2705)

    São Paulo, 01509-900

Other trials in Brazil

Italy9 sites

  • Medical Oncology Ospedale San Donato ( Site 0812)

    Arezzo, 52100

  • IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0801)

    Bari, 70124

  • Ospedale Policlinico S. Orsola-Malpighi ( Site 0803)

    Bologna, 40138

  • Ospedale Antonio Perrino ( Site 0806)

    Brindisi, 72100

  • Azienda Ospedaliera per l Emergenza Cannizzaro ( Site 0807)

    Catania, 95126

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0800)

    Meldola, Emilia-Romagna, 47014

  • Ospedale dell Angelo ( Site 0810)

    Mestre, Venezia, 30174

  • Istituto Nazionale Tumori Fondazione Pascale ( Site 0808)

    Naples, 80131

  • Policlinico Universitario Agostino Gemelli ( Site 0805)

    Rome, Roma, 00168

Other trials in Italy

Australia8 sites

  • Chris OBrien Lifehouse ( Site 1605)

    Camperdown, New South Wales, 2050

  • Monash Health ( Site 1606)

    Clayton, Victoria, 3168

  • Epworth Freemasons Hospital ( Site 1609)

    Melbourne, Victoria, 3002

  • Sir Charles Gairdner Hospital ( Site 1604)

    Nedlands, Western Australia, 6009

  • Prince of Wales Hospital [Australia] ( Site 1603)

    Randwick, New South Wales, 2031

  • Mater Misericordiae Ltd ( Site 1608)

    South Brisbane, Queensland, 4101

  • Royal North Shore Hospital ( Site 1600)

    St Leonards, New South Wales, 2065

  • The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 1602)

    Westmead, New South Wales, 2145

Other trials in Australia

Poland8 sites

  • Bialostockie Centrum Onkologii ( Site 1005)

    Bialystok, Podlaskie Voivodeship, 15-027

  • Centrum Onkologii Instytut im. MSC Oddział w Gliwicach ( Site 1017)

    Gliwice, Silesian Voivodeship, 44-102

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1019)

    Krakow, Lesser Poland Voivodeship, 31-826

  • Instytut Centrum Zdrowia Matki Polki ( Site 1020)

    Lodz, Łódź Voivodeship, 93-338

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1008)

    Lublin, Lower Silesian Voivodeship, 20-081

  • Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 1004)

    Poznan, Greater Poland Voivodeship, 61-866

  • Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 1011)

    Warsaw, Masovian Voivodeship, 00-315

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1009)

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Spain8 sites

  • Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1202)

    A Coruña, La Coruna, 15006

  • Institut Catala d Oncologia Badalona ( Site 1201)

    Badalona, Barcelona, 08916

  • Parc de Salut Mar ( Site 1200)

    Barcelona, 08003

  • Hospital Universitario Reina Sofia ( Site 1207)

    Córdoba, 14004

  • Hospital Clinico San Carlos ( Site 1209)

    Madrid, 28040

  • Hospital Materno Infantil [Malaga, Spain] ( Site 1208)

    Málaga, 29011

  • Instituto Valenciano de Oncologia - IVO ( Site 1205)

    Valencia, Valenciana, Comunitat, 46009

  • Hospital General Universitario de Valencia ( Site 1203)

    Valencia, Valenciana, Comunitat, 46014

Other trials in Spain

Germany7 sites

  • Charite Universitaetsmedizin Berlin ( Site 0609)

    Berlin, 13353

  • Universitaetsklinikum Essen ( Site 0616)

    Essen, North Rhine-Westphalia, 45147

  • Universitaetsklinikum Jena ( Site 0612)

    Jena, Thuringia, 07747

  • Universitaetsmedizin Mannheim. Klinik fuer Kinder und Jugendmedizin ( Site 0622)

    Mannheim, Baden-Wurttemberg, 68167

  • Universitaetsklinikum Muenster ( Site 0615)

    Münster, Baden-Wurttemberg, 48149

  • Caritas-Krankenhaus St. Josef Regensburg ( Site 0613)

    Regensburg, Bavaria, 93053

  • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0623)

    Wiesbaden, Hesse, 65199

Other trials in Germany

Argentina6 sites

  • Hospital Aleman ( Site 2600)

    Buenos Aires, C1118AAT

  • Hospital Italiano de Buenos Aires ( Site 2603)

    Buenos Aires, C1199ABB

  • IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2607)

    Caba, Buenos Aires, C1012AAR

  • Hospital Italiano de La Plata ( Site 2601)

    La Plata, Buenos Aires, B1900AXI

  • Centro Oncologico Riojano Integral ( Site 2605)

    La Rioja, 5300

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 2606)

    Mar del Plata, Buenos Aires, B7600FZO

Other trials in Argentina

Mexico6 sites

  • Centro Estatal de Cancerologia de Chihuahua ( Site 3101)

    Chihuahua City, 31000

  • Centro de Investigacion Clinica Gramel ( Site 3107)

    Mexico City, 03720

  • Centro Oncologico Internacional. SEDNA ( Site 3106)

    Mexico City, 04700

  • Consultorio Dentro de la Torre Medica Dalinde Oncologia Medica ( Site 3108)

    Mexico City, 06760

  • I CAN Oncology SA de SV ( Site 3102)

    Monterrey, Nuevo León, 64710

  • Hospital San Lucas Cardiologica del Sureste ( Site 3103)

    Tuxtla Gutiérrez, Chiapas, 29090

Other trials in Mexico

Turkey (Türkiye)6 sites

  • Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi ( Site 1303)

    Adana, 01120

  • Cukurova Uni. Tip Fakultesi ( Site 1302)

    Adana, 01330

  • Gazi Universitesi Tip Fakultesi ( Site 1308)

    Ankara, 05600

  • Baskent Universitesi Ankara Hastanesi ( Site 1300)

    Ankara, 06490

  • Akdeniz Universitesi Tıp Fakultesi ( Site 1301)

    Antalya, 07070

  • Uludag Universitesi Tip Fakultesi ( Site 1307)

    Bursa, 16059

Other trials in Turkey (Türkiye)

United Kingdom6 sites

  • Western General Hospital ( Site 1411)

    Edinburgh, Edinburgh, City of, EH4 2XU

  • UCLH NHS Foundation Trust ( Site 1405)

    London, London, City of, NW1 2PG

  • The James Cook University Hospital ( Site 1403)

    Middlesbrough, TS4 3BW

  • Northern Centre for Cancer Care ( Site 1408)

    Newcastle upon Tyne, NE7 7DN

  • Mount Vernon Cancer Centre ( Site 1409)

    Northwood, London, City of, HA6 2RN

  • Churchill Hospital ( Site 1406)

    Oxford, Oxfordshire, OX3 7LE

Other trials in United Kingdom

Belgium5 sites

  • Cliniques Universitaires Saint-Luc ( Site 3203)

    Brussels, Bruxelles-Capitale, Region de, 1200

  • UZA University Hospital Antwerp ( Site 3204)

    Edegem, Antwerpen, 2650

  • AZ Maria Middelares Gent ( Site 3202)

    Ghent, Oost-Vlaanderen, 9000

  • UZ Leuven ( Site 3200)

    Leuven, Antwerpen, 3000

  • AZ Delta ( Site 3206)

    Roeselare, West-Vlaanderen, 8800

Other trials in Belgium

South Korea5 sites

  • Seoul National University Bundang Hospital ( Site 1802)

    Seongnam-si, Kyonggi-do, 13620

  • Seoul National University Hospital ( Site 1801)

    Seoul, 03080

  • Severance Hospital Yonsei University Health System ( Site 1804)

    Seoul, 03722

  • Asan Medical Center ( Site 1800)

    Seoul, 05505

  • Samsung Medical Center ( Site 1803)

    Seoul, 06351

Other trials in South Korea

Taiwan5 sites

  • China Medical University Hospital ( Site 1903)

    Taichung, 404

  • Taichung Veterans General Hospital ( Site 1902)

    Taichung, 40705

  • National Taiwan University Hospital ( Site 1904)

    Taipei, 10002

  • Taipei Veterans General Hospital ( Site 1900)

    Taipei, 11217

  • Linkou Chang Gung Memorial Hospital ( Site 1901)

    Taoyuan, 333

Other trials in Taiwan

Israel4 sites

  • Rambam Medical Center ( Site 0700)

    Haifa, 3525408

  • Edith Wolfson Medical Center ( Site 0703)

    Holon, Tell Abib, 5822012

  • Meir Medical Center ( Site 0702)

    Kfar Saba, Central District, 4428132

  • Chaim Sheba Medical Center ( Site 0707)

    Ramat Gan, 5262000

Other trials in Israel

Austria3 sites

  • Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 3301)

    Graz, Styria, 8036

  • Medizinische Universitat Innsbruck ( Site 3302)

    Innsbruck, Tyrol, 6020

  • Medizinische Universitat Wien ( Site 3300)

    Vienna, State of Vienna, 1090

Other trials in Austria

Ireland2 sites

  • Cork University Hospital ( Site 1400)

    Cork, T12 YE02

  • St James Hospital ( Site 1401)

    Dublin, Dublin 8

Other trials in Ireland

About this study

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)

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.

Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenvatinibDrug

    Also called E7080, MK-7902, LENVIMA®

    Lenvatinib 4 mg or 10 mg capsules at a total daily dose of 20 mg taken by mouth once per day.

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    Pembrolizumab 200 mg intravenous (IV) infusion given on Day 1 of each cycle.

  • PaclitaxelDrug

    Also called TAXOL®, ONXAL®

    Paclitaxel 175 mg/m^2 IV infusion given on Day 1 of each cycle.

  • CarboplatinDrug

    Also called PARAPLATIN®

    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.

Study groups in NCT03884101
Study groupRoleWhat they receive
Lenvatinib + PembrolizumabExperimentalParticipants receive lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
Receives: Drug: Lenvatinib; Biological: Pembrolizumab
Paclitaxel + CarboplatinActive comparatorParticipants receive paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
Receives: Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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) in Mismatch Repair Proficient (pMMR) Participants

    PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS of pMMR participants was presented.

    Measured: Up to approximately 44 months

  2. PFS Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants

    PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS of all randomized participants was presented.

    Measured: Up to approximately 44 months

  3. Overall Survival (OS) in pMMR Participants

    OS was measured from the time of randomization up to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. The OS for pMMR participants is presented.

    Measured: Up to approximately 51 months

  4. OS in All Randomized Participants

    OS was measured from the time of randomization up to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. The OS for all randomized participants is presented.

    Measured: Up to approximately 51 months

Secondary outcomes (8)

  1. Objective Response Rate (ORR) Based on RECIST 1.1 as Assessed by BICR in pMMR Participants

    ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of pMMR participants who experienced a CR or PR is presented.

    Measured: Up to approximately 51 months

  2. ORR Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants

    ORR was defined as the percentage of participants who had a CR: Disappearance of all target lesions or a PR: At least a 30% decrease in the sum of diameters of target lesions as assessed using RECIST 1.1. The percentage of all randomized participants who experienced a CR or PR is presented.

    Measured: Up to approximately 51 months

  3. 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 Participants

    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.

    Measured: Baseline and up to approximately 18 weeks

  4. Mean Change From Baseline in the Global Health Status/Quality of Life Score of the EORTC QLQ-C30 in All Randomized Participants

    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 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.

    Measured: Baseline and up to approximately 18 weeks

  5. Number of Participants Who Experienced an Adverse Event (AE)

    An AE was 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. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). Per protocol, the number of participants who experienced one or more AEs was reported for the first course lenvatinib + pembrolizumab and paclitaxel + carboplatin arms.

    Measured: Up to approximately 68 months

  6. Number of Participants Who Experienced a Serious Adverse Event (SAE)

    An SAE was an AE that resulted in death, was life-threatening, required or prolonged hospitalization, resulted in persistent or significant disability, was a congenital birth defect, or was another important medical event. Per protocol, the number of participants who experienced one or more SAEs was reported for the first course lenvatinib + pembrolizumab and paclitaxel + carboplatin arms.

    Measured: Up to approximately 68 months

  7. Number of Participants Who Experienced an Immune-Related Adverse Event (irAE)

    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. Immune-related AEs (irAEs) were AEs that were considered immune-mediated or potentially immune-mediated and are well-documented for pembrolizumab. These irAEs may occur shortly after the first dose or several months after the last dose of pembrolizumab treatment and may affect more than one body system simultaneously. Per protocol, the number of participants who experienced one or more irAEs was reported for the first course lenvatinib + pembrolizumab and paclitaxel + carboplatin arms.

    Measured: Up to approximately 68 months

  8. Number of Participants Who Discontinued Study Intervention Due to an AE

    An AE was 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. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). Per protocol, the number of participants who discontinued any study intervention (pembrolizumab and/or lenvatinib or paclitaxel and/or carboplatin) due to an AE was reported for the first course lenvatinib + pembrolizumab and paclitaxel + carboplatin arms.

    Measured: Up to approximately 68 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2019
  2. Study start11 Apr 2019
  3. Primary completion2 Oct 2023
  4. Study completion5 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
842 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03884101
Sponsor's protocol ID
7902-001
Other IDs
MK-7902-001, ENGOT-en9, 194710, 2023-505614-17-00, U1111-1292-1245, 2018-003009-24, 2018, 2023
Acronym
LEAP-001
Status last verified
Jan 2026
First submitted
19 Mar 2019
Last updated
2 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Marth C, Moore RG, Bidzinski M, Pignata S, Ayhan A, Rubio MJ, Beiner M, Hall M, Vulsteke C, Braicu EI, Sonoda K, Wu X, Frentzas S, Mattar A, Lheureux S, Chen X, Hasegawa K, Magallanes-Maciel M, Choi CH, Shalkova M, Kaen D, Wang PH, Berger R, Okpara CE, McKenzie J, Yao L, Orlowski R, Khemka V, Gilbert L, Makker V; ENGOT-en9/LEAP-001 Investigators. First-Line Lenvatinib Plus Pembrolizumab Versus Chemotherapy for Advanced Endometrial Cancer: A Randomized, Open-Label, Phase III Trial. J Clin Oncol. 2025 Mar 20;43(9):1083-1100. doi: 10.1200/JCO-24-01326. Epub 2024 Nov 26.

    PubMed 39591551

  • Marth C, Lorusso D, Bidzinski M, Scollo P, Vardar MA, Oaknin A, Kaen DL, Nogueira-Rodrigues A, Miller DS, Hasegawa K, MacKay H, Moore RG, Santin AD, Yunokawa M, Romero I, Pignata S, Baron-Hay S, Kim YM, Amit A, Ghamande S, Danska-Bidzinska A, Tarnawski R, Wang PH, Yu Z, Slomovitz BM, Okpara CE, McKenzie J, Meng R, Orlowski R, Makker V. Lenvatinib plus pembrolizumab in participants with advanced or recurrent endometrial cancer: Study 309/KEYNOTE-775 and ENGOT-en9/LEAP-001 post-(neo)adjuvant therapy outcomes. Int J Gynecol Cancer. 2026 Jul;36(7):104693. doi: 10.1016/j.ijgc.2026.104693. Epub 2026 Apr 12.

    PubMed 42167105

  • Marth C, Moore RG, Bidzinski M, Salutari V, Altundag O, Rubio MJ, Levy T, Stillie A, Vulsteke C, Witteler R, Ariyoshi K, Wu X, Frentzas S, Mattar A, Slomovitz BM, Lheureux S, Chen X, Hasegawa K, Magallanes M, Choi CH, Shalkova M, Kaen DL, Cadoo K, Yao L, McKenzie J, Okpara CE, Meng R, Orlowski R, Gilbert L, Makker V. First-line lenvatinib plus pembrolizumab versus chemotherapy for advanced endometrial cancer: 1-Year follow-up after final analysis of the ENGOT-en9/LEAP-001 phase 3 trial. Int J Gynecol Cancer. 2026 Jan;36(1):102795. doi: 10.1016/j.ijgc.2025.102795. Epub 2025 Nov 11.

    PubMed 41494216

  • Marth C, Tarnawski R, Tyulyandina A, Pignata S, Gilbert L, Kaen D, Rubio MJ, Frentzas S, Beiner M, Magallanes-Maciel M, Farrelly L, Choi CH, Berger R, Lee C, Vulsteke C, Hasegawa K, Braicu EI, Wu X, McKenzie J, Lee JJ, Makker V. Phase 3, randomized, open-label study of pembrolizumab plus lenvatinib versus chemotherapy for first-line treatment of advanced or recurrent endometrial cancer: ENGOT-en9/LEAP-001. Int J Gynecol Cancer. 2022 Jan;32(1):93-100. doi: 10.1136/ijgc-2021-003017. Epub 2021 Nov 19.

    PubMed 34799418

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenvatinib, Pembrolizumab and Paclitaxel in people with Endometrial Neoplasms, run by Merck Sharp & Dohme LLC at 195 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 195 sites in United States, Japan, China, Canada, Russia and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) in Mismatch Repair Proficient (pMMR) Participants (time frame: Up to approximately 44 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03884101, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.

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