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

NCT ID: NCT03884101

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 842 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-11
• Study Completion Date: 2025-02-05

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.

Conditions

Endometrial Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lenvatinib + Pembrolizumab

Participants receive lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.

Group Type: EXPERIMENTAL

Lenvatinib

Intervention Type: DRUG

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

Pembrolizumab

Intervention Type: BIOLOGICAL

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

Paclitaxel + Carboplatin

Participants receive paclitaxel and carboplatin once at the start of each 3-week treatment cycle.

Group Type: ACTIVE_COMPARATOR

Paclitaxel

Intervention Type: DRUG

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

Carboplatin

Intervention Type: DRUG

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.

Interventions

Lenvatinib

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

Intervention Type: DRUG

Pembrolizumab

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

Intervention Type: BIOLOGICAL

Paclitaxel

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

E7080, MK-7902, LENVIMA®; MK-3475, KEYTRUDA®; TAXOL®, ONXAL®; PARAPLATIN®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

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, Styria, Austria

Medizinische Universitat Innsbruck ( Site 3302)

Innsbruck, Tyrol, Austria

Medizinische Universitat Wien ( Site 3300)

Vienna, Vienna, 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)

Ghent, Oost-Vlaanderen, Belgium

AZ Delta ( Site 3206)

Roeselare, West-Vlaanderen, Belgium

Instituto do Cancer do Ceara ( Site 2703)

Fortaleza, Ceará, Brazil

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

Goiânia, Goiás, Brazil

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

Belo Horizonte, Minas Gerais, Brazil

Hospital de Caridade de Ijui ( Site 2712)

Ijuí, 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)

São José do Rio Preto, São 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)

São Paulo, , Brazil

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2713)

São Paulo, , Brazil

A.C. Camargo Cancer Center ( Site 2705)

São 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 Municipality, China

Peking Union Medical College Hospital ( Site 2501)

Beijing, Beijing Municipality, China

Beijing Cancer Hospital ( Site 2504)

Beijing, Beijing Municipality, China

Chongqing Cancer Hospital ( Site 2513)

Chongqing, Chongqing Municipality, 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 Municipality, China

Obstetrics and Gynecology Hosp. Fudan University ( Site 2503)

Shanghai, Shanghai Municipality, China

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

Ürümqi, 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)

Münster, Baden-Wurttemberg, Germany

Caritas-Krankenhaus St. Josef Regensburg ( Site 0613)

Regensburg, Bavaria, Germany

HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0623)

Wiesbaden, Hesse, Germany

Universitaetsklinikum Essen ( Site 0616)

Essen, North Rhine-Westphalia, Germany

Universitaetsklinikum Jena ( Site 0612)

Jena, Thuringia, 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 District, 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)

Tōon, Ehime, Japan

Kurume University Hospital ( Site 2403)

Kurume, Fukuoka, Japan

Gunma Prefectural Cancer Center ( Site 2404)

Ōta, Gunma, Japan

National Hospital Organization Hokkaido Cancer Center ( Site 2408)

Sapporo, Hokkaido, Japan

Hyogo Cancer Center ( Site 2414)

Akashi, Hyōgo, 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

Hospital San Lucas Cardiologica del Sureste ( Site 3103)

Tuxtla Gutiérrez, Chiapas, Mexico

I CAN Oncology SA de SV ( Site 3102)

Monterrey, Nuevo León, Mexico

Centro Estatal de Cancerologia de Chihuahua ( Site 3101)

Chihuahua City, , Mexico

Centro de Investigacion Clinica Gramel ( Site 3107)

Mexico City, , Mexico

Centro Oncologico Internacional. SEDNA ( Site 3106)

Mexico City, , Mexico

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

Mexico City, , Mexico

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

Poznan, Greater Poland Voivodeship, Poland

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

Krakow, Lesser Poland Voivodeship, Poland

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

Lublin, Lower Silesian Voivodeship, Poland

Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 1011)

Warsaw, Masovian Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

Bialostockie Centrum Onkologii ( Site 1005)

Bialystok, Podlaskie Voivodeship, Poland

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

Gliwice, Silesian Voivodeship, Poland

Instytut Centrum Zdrowia Matki Polki ( Site 1020)

Lodz, Łódź Voivodeship, Poland

Krasnoyarsk Regional Clinical oncology dispensary ( Site 1118)

Krasnoyarsk, Krasnoyarsk Krai, Russia

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

Moscow, Moscow, Russia

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

Moscow, Moscow, Russia

Medical Rehabilitation Center ( Site 1101)

Moscow, Moscow, Russia

Samara Regional Clinical Oncology Center ( Site 1117)

Samara, Samara Oblast, Russia

St.Petersburg Clinical Hospital RAS ( Site 1124)

Saint Petersburg, Sankt-Peterburg, Russia

Railway Hospital of OJSC ( Site 1122)

Saint Petersburg, Sankt-Peterburg, Russia

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

Saint Petersburg, Sankt-Peterburg, Russia

SPb SBHI City Clinical Oncological Dispensary ( Site 1104)

Saint Petersburg, Sankt-Peterburg, Russia

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1108)

Kazan', Tatarstan, Respublika, Russia

Siberian State Medical University ( Site 1121)

Tomsk, Tomsk Oblast, Russia

Seoul National University Bundang Hospital ( Site 1802)

Seongnam-si, Kyonggi-do, South Korea

Seoul National University Hospital ( Site 1801)

Seoul, , South Korea

Severance Hospital Yonsei University Health System ( Site 1804)

Seoul, , South Korea

Asan Medical Center ( Site 1800)

Seoul, , South Korea

Samsung Medical Center ( Site 1803)

Seoul, , South Korea

Institut Catala d Oncologia Badalona ( Site 1201)

Badalona, Barcelona, Spain

Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1202)

A Coruña, 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)

Córdoba, , Spain

Hospital Clinico San Carlos ( Site 1209)

Madrid, , Spain

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

Málaga, , 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 District, , Taiwan

Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi ( Site 1303)

Adana, , Turkey (Türkiye)

Cukurova Uni. Tip Fakultesi ( Site 1302)

Adana, , Turkey (Türkiye)

Gazi Universitesi Tip Fakultesi ( Site 1308)

Ankara, , Turkey (Türkiye)

Baskent Universitesi Ankara Hastanesi ( Site 1300)

Ankara, , Turkey (Türkiye)

Akdeniz Universitesi Tıp Fakultesi ( Site 1301)

Antalya, , Turkey (Türkiye)

Uludag Universitesi Tip Fakultesi ( Site 1307)

Bursa, , Turkey (Türkiye)

Clinical oncology dispensary of Dnipro ( Site 1512)

Dnipro, Dnipropetrovsk Oblast, Ukraine

City Clinical Hosp.4 of DCC ( Site 1501)

Dnipro, Dnipropetrovsk Oblast, Ukraine

MI Precarpathian Clinical Oncology Center ( Site 1503)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

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

Kharkiv, Kharkivs’ka Oblast’, Ukraine

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

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Khmelnitskiy Regional Onkology Dispensary ( Site 1513)

Khmelnitskiy, Khmelnytskyi Oblast, Ukraine

Medical Center Asklepion LLC ( Site 1514)

Khodosovka, 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, Odesa 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

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Canada; China; Germany; Ireland; Israel; Italy; Japan; Mexico; Poland; Russia; South Korea; Spain; Taiwan; Turkey (Türkiye); Ukraine; United Kingdom

References

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.

Reference Type: RESULT

PMID: 39591551 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34799418 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

https://msd.trialsummaries.com/Study/StudyDetails?id=26245&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

MK-7902-001

Identifier Type: OTHER

Identifier Source: secondary_id

ENGOT-en9

Identifier Type: OTHER

Identifier Source: secondary_id

194710

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-505614-17

Identifier Type: OTHER

Identifier Source: secondary_id

2018-003009-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

7902-001

Identifier Type: -

Identifier Source: org_study_id