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

NCT03884101 | Completed Phase 3 Results DMC FDA Drug

• 7 other identifiers: 7902-001MK-7902-001ENGOT-en91947102023-505614-17-00U1111-1292-12452018-003009-24
• Study Type: interventional
• Target: 842
• Locations: 21 countries
• Sites: 192

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

Outcome Measures

Primary Outcomes (4)

• 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.

  Up to approximately 44 months

• 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.

  Up to approximately 44 months

• 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.

  Up to approximately 51 months

• 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.

  Up to approximately 51 months

Secondary Outcomes (8)

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

  Up to approximately 51 months

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

  Up to approximately 51 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 Participants

  Baseline and up to approximately 18 weeks

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

  Baseline and up to approximately 18 weeks

• Number of Participants Who Experienced an Adverse Event (AE)

  Up to approximately 68 months

Study Arms (2)

Lenvatinib + Pembrolizumab

EXPERIMENTAL

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

Drug: Lenvatinib; Biological: Pembrolizumab

Paclitaxel + Carboplatin

ACTIVE COMPARATOR

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

Drug: Paclitaxel; Drug: Carboplatin

Interventions

Lenvatinib DRUG

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

Also known as: E7080, MK-7902, LENVIMA®

Lenvatinib + Pembrolizumab

Pembrolizumab BIOLOGICAL

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

Also known as: MK-3475, KEYTRUDA®

Lenvatinib + Pembrolizumab

Paclitaxel DRUG

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

Also known as: TAXOL®, ONXAL®

Paclitaxel + Carboplatin

Carboplatin 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.

Also known as: PARAPLATIN®

Paclitaxel + Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Has carcinosarcoma (malignant mixed Műllerian tumor), endometrial leiomyosarcoma or other high grade sarcomas, or endometrial stromal sarcomas
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Eisai Inc.: collaborator

Study Sites (195)

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

Mobile, Alabama, 36604, United States

Location

Arizona Oncology Associates PC- HOPE ( Site 8005)

Tucson, Arizona, 85711, United States

Location

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

Los Angeles, California, 90095, United States

Location

University of Colorado Cancer Center ( Site 0204)

Aurora, Colorado, 80045, United States

Location

Smilow Cancer Hospital at Yale New Haven ( Site 0202)

New Haven, Connecticut, 06511, United States

Location

University of Miami Health System ( Site 0249)

Miami, Florida, 33136, United States

Location

Georgia Cancer Center at Augusta University ( Site 0222)

Augusta, Georgia, 30912, United States

Location

Women's Cancer Care ( Site 0208)

Covington, Louisiana, 70433, United States

Location

Maine Medical Partners ( Site 0217)

Scarborough, Maine, 04074, United States

Location

Minnesota Oncology Hematology, PA ( Site 8003)

Minneapolis, Minnesota, 55404, United States

Location

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

Basking Ridge, New Jersey, 07920, United States

Location

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

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0273)

Middletown, New Jersey, 07748, United States

Location

MSKCC-Bergen ( Site 0276)

Montvale, New Jersey, 07645, United States

Location

Holy Name Medical Center ( Site 0235)

Teaneck, New Jersey, 07666, United States

Location

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

Commack, New York, 11725, United States

Location

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

Harrison, New York, 10604, United States

Location

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

New York, New York, 10011, United States

Location

Memorial Sloan Kettering Cancer Center ( Site 0246)

New York, New York, 10022, United States

Location

University of Rochester ( Site 0238)

Rochester, New York, 14642, United States

Location

Memorial Sloan Kettering Cancer Center - Nassau ( Site 0275)

Uniondale, New York, 11553, United States

Location

University of North Carolina- Chapel Hill ( Site 0254)

Chapel Hill, North Carolina, 27599, United States

Location

Roger Maris Cancer Center ( Site 0277)

Fargo, North Dakota, 58102, United States

Location

Willamette Valley Cancer Institute and Research Center ( Site 8004)

Eugene, Oregon, 97401, United States

Location

Sanford Cancer Center Oncology Clinic ( Site 0205)

Sioux Falls, South Dakota, 57104, United States

Location

Parkland Health & Hospital System ( Site 0272)

Dallas, Texas, 75235, United States

Location

University of Texas Southwestern Medical Center ( Site 0264)

Dallas, Texas, 75390-9015, United States

Location

Texas Oncology-The Woodlands ( Site 8000)

The Woodlands, Texas, 77380, United States

Location

Legacy Salmon Creek Medical Center ( Site 0253)

Vancouver, Washington, 98686, United States

Location

IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2607)

Caba, Buenos Aires, C1012AAR, Argentina

Location

Hospital Italiano de La Plata ( Site 2601)

La Plata, Buenos Aires, B1900AXI, Argentina

Location

Instituto de Investigaciones Clinicas Mar del Plata ( Site 2606)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

Location

Hospital Aleman ( Site 2600)

Buenos Aires, C1118AAT, Argentina

Location

Hospital Italiano de Buenos Aires ( Site 2603)

Buenos Aires, C1199ABB, Argentina

Location

Centro Oncologico Riojano Integral ( Site 2605)

La Rioja, 5300, Argentina

Location

Chris OBrien Lifehouse ( Site 1605)

Camperdown, New South Wales, 2050, Australia

Location

Prince of Wales Hospital [Australia] ( Site 1603)

Randwick, New South Wales, 2031, Australia

Location

Royal North Shore Hospital ( Site 1600)

St Leonards, New South Wales, 2065, Australia

Location

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

Westmead, New South Wales, 2145, Australia

Location

Mater Misericordiae Ltd ( Site 1608)

South Brisbane, Queensland, 4101, Australia

Location

Monash Health ( Site 1606)

Clayton, Victoria, 3168, Australia

Location

Epworth Freemasons Hospital ( Site 1609)

Melbourne, Victoria, 3002, Australia

Location

Sir Charles Gairdner Hospital ( Site 1604)

Nedlands, Western Australia, 6009, Australia

Location

Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 3301)

Graz, Styria, 8036, Austria

Location

Medizinische Universitat Innsbruck ( Site 3302)

Innsbruck, Tyrol, 6020, Austria

Location

Medizinische Universitat Wien ( Site 3300)

Vienna, Vienna, 1090, Austria

Location

UZA University Hospital Antwerp ( Site 3204)

Edegem, Antwerpen, 2650, Belgium

Location

UZ Leuven ( Site 3200)

Leuven, Antwerpen, 3000, Belgium

Location

Cliniques Universitaires Saint-Luc ( Site 3203)

Brussels, Bruxelles-Capitale, Region de, 1200, Belgium

Location

AZ Maria Middelares Gent ( Site 3202)

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

AZ Delta ( Site 3206)

Roeselare, West-Vlaanderen, 8800, Belgium

Location

Instituto do Cancer do Ceara ( Site 2703)

Fortaleza, Ceará, 60430-230, Brazil

Location

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

Goiânia, Goiás, 74605-070, Brazil

Location

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

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Hospital de Caridade de Ijui ( Site 2712)

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

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

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

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

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

Location

Instituto Nacional do Cancer II ( Site 2707)

Rio de Janeiro, 20220-410, Brazil

Location

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

São Paulo, 01317-001, Brazil

Location

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2713)

São Paulo, 01321-001, Brazil

Location

A.C. Camargo Cancer Center ( Site 2705)

São Paulo, 01509-900, Brazil

Location

Cross Cancer Institute ( Site 0408)

Edmonton, Alberta, T6G 1Z2, Canada

Location

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

Kelowna, British Columbia, V1Y 5L3, Canada

Location

BC Cancer-Vancouver Center ( Site 0412)

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Juravinski Cancer Centre ( Site 0406)

Hamilton, Ontario, L8V 1C3, Canada

Location

Kingston Health Sciences Centre ( Site 0401)

Kingston, Ontario, K7L 2V7, Canada

Location

The Credit Valley Hospital ( Site 0403)

Mississauga, Ontario, L5M 2N1, Canada

Location

Sunnybrook Research Institute ( Site 0410)

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre ( Site 0409)

Toronto, Ontario, M5G 2M9, Canada

Location

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

Montreal, Quebec, H1T 2M4, Canada

Location

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

Montreal, Quebec, H2X 3E4, Canada

Location

McGill University Health Centre ( Site 0404)

Montreal, Quebec, H4A 3J1, Canada

Location

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

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Anhui Provincial Cancer Hospital ( Site 2509)

Hefei, Anhui, 230001, China

Location

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

Beijing, Beijing Municipality, 100032, China

Location

Peking Union Medical College Hospital ( Site 2501)

Beijing, Beijing Municipality, 100032, China

Location

Beijing Cancer Hospital ( Site 2504)

Beijing, Beijing Municipality, 100142, China

Location

Chongqing Cancer Hospital ( Site 2513)

Chongqing, Chongqing Municipality, 400030, China

Location

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

Guangzhou, Guangdong, 510080, China

Location

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

Nanning, Guangxi, 530021, China

Location

Hubei Cancer Hospital ( Site 2510)

Wuhan, Hubei, 430079, China

Location

Xiangya Hospital Central-South University ( Site 2512)

Changsha, Hunan, 410008, China

Location

Nanjing Maternity and Child Health Care Hospital ( Site 2508)

Nanjing, Jiangsu, 210011, China

Location

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

Xi'an, Shaanxi, 710061, China

Location

Fudan University Shanghai Cancer Center ( Site 2500)

Shanghai, Shanghai Municipality, 200032, China

Location

Obstetrics and Gynecology Hosp. Fudan University ( Site 2503)

Shanghai, Shanghai Municipality, 200090, China

Location

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

Ürümqi, Xinjiang, 830054, China

Location

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

Hangzhou, Zhejiang, 310006, China

Location

Zhejiang Cancer Hospital ( Site 2506)

Hangzhou, Zhejiang, 310022, China

Location

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

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Universitaetsklinikum Muenster ( Site 0615)

Münster, Baden-Wurttemberg, 48149, Germany

Location

Caritas-Krankenhaus St. Josef Regensburg ( Site 0613)

Regensburg, Bavaria, 93053, Germany

Location

HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0623)

Wiesbaden, Hesse, 65199, Germany

Location

Universitaetsklinikum Essen ( Site 0616)

Essen, North Rhine-Westphalia, 45147, Germany

Location

Universitaetsklinikum Jena ( Site 0612)

Jena, Thuringia, 07747, Germany

Location

Charite Universitaetsmedizin Berlin ( Site 0609)

Berlin, 13353, Germany

Location

Cork University Hospital ( Site 1400)

Cork, T12 YE02, Ireland

Location

St James Hospital ( Site 1401)

Dublin, Dublin 8, Ireland

Location

Meir Medical Center ( Site 0702)

Kfar Saba, Central District, 4428132, Israel

Location

Edith Wolfson Medical Center ( Site 0703)

Holon, Tell Abib, 5822012, Israel

Location

Rambam Medical Center ( Site 0700)

Haifa, 3525408, Israel

Location

Chaim Sheba Medical Center ( Site 0707)

Ramat Gan, 5262000, Israel

Location

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

Meldola, Emilia-Romagna, 47014, Italy

Location

Policlinico Universitario Agostino Gemelli ( Site 0805)

Rome, Roma, 00168, Italy

Location

Ospedale dell Angelo ( Site 0810)

Mestre, Venezia, 30174, Italy

Location

Medical Oncology Ospedale San Donato ( Site 0812)

Arezzo, 52100, Italy

Location

IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0801)

Bari, 70124, Italy

Location

Ospedale Policlinico S. Orsola-Malpighi ( Site 0803)

Bologna, 40138, Italy

Location

Ospedale Antonio Perrino ( Site 0806)

Brindisi, 72100, Italy

Location

Azienda Ospedaliera per l Emergenza Cannizzaro ( Site 0807)

Catania, 95126, Italy

Location

Istituto Nazionale Tumori Fondazione Pascale ( Site 0808)

Naples, 80131, Italy

Location

Ehime University Hospital ( Site 2413)

Tōon, Ehime, 791-0295, Japan

Location

Kurume University Hospital ( Site 2403)

Kurume, Fukuoka, 830-0011, Japan

Location

Gunma Prefectural Cancer Center ( Site 2404)

Ōta, Gunma, 373-8550, Japan

Location

National Hospital Organization Hokkaido Cancer Center ( Site 2408)

Sapporo, Hokkaido, 003-0804, Japan

Location

Hyogo Cancer Center ( Site 2414)

Akashi, Hyōgo, 673-8558, Japan

Location

Nippon Medical School Musashi Kosugi Hospital ( Site 2417)

Kawasaki, Kanagawa, 211-8533, Japan

Location

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

Kawasaki, Kanagawa, 216-8511, Japan

Location

University of the Ryukyus Hospital ( Site 2412)

Nakagami-gun, Okinawa, 903-0215, Japan

Location

Saitama Medical University International Medical Center ( Site 2410)

Hidaka, Saitama, 350-1298, Japan

Location

Saitama Cancer Center ( Site 2406)

Kitaadachi-gun, Saitama, 362-0806, Japan

Location

National Defense Medical College Hospital ( Site 2418)

Tokorozawa, Saitama, 359-8513, Japan

Location

Kyorin University Hospital ( Site 2402)

Mitaka, Tokyo, 181-8611, Japan

Location

National Hospital Organization Kyushu Cancer Center ( Site 2405)

Fukuoka, 811-1395, Japan

Location

Niigata Cancer Center Hospital ( Site 2415)

Niigata, 951-8566, Japan

Location

Osaka International Cancer Institute ( Site 2409)

Osaka, 541-8567, Japan

Location

The Cancer Institute Hospital of JFCR ( Site 2401)

Tokyo, 135-8550, Japan

Location

Showa University Hospital ( Site 2419)

Tokyo, 142-8666, Japan

Location

Keio University Hospital ( Site 2411)

Tokyo, 160-8582, Japan

Location

Hospital San Lucas Cardiologica del Sureste ( Site 3103)

Tuxtla Gutiérrez, Chiapas, 29090, Mexico

Location

I CAN Oncology SA de SV ( Site 3102)

Monterrey, Nuevo León, 64710, Mexico

Location

Centro Estatal de Cancerologia de Chihuahua ( Site 3101)

Chihuahua City, 31000, Mexico

Location

Centro de Investigacion Clinica Gramel ( Site 3107)

Mexico City, 03720, Mexico

Location

Centro Oncologico Internacional. SEDNA ( Site 3106)

Mexico City, 04700, Mexico

Location

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

Mexico City, 06760, Mexico

Location

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

Poznan, Greater Poland Voivodeship, 61-866, Poland

Location

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

Krakow, Lesser Poland Voivodeship, 31-826, Poland

Location

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

Lublin, Lower Silesian Voivodeship, 20-081, Poland

Location

Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 1011)

Warsaw, Masovian Voivodeship, 00-315, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Bialostockie Centrum Onkologii ( Site 1005)

Bialystok, Podlaskie Voivodeship, 15-027, Poland

Location

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

Gliwice, Silesian Voivodeship, 44-102, Poland

Location

Instytut Centrum Zdrowia Matki Polki ( Site 1020)

Lodz, Łódź Voivodeship, 93-338, Poland

Location

Krasnoyarsk Regional Clinical oncology dispensary ( Site 1118)

Krasnoyarsk, Krasnoyarsk Krai, 660133, Russia

Location

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

Moscow, Moscow, 115478, Russia

Location

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

Moscow, Moscow, 115682, Russia

Location

Medical Rehabilitation Center ( Site 1101)

Moscow, Moscow, 125367, Russia

Location

Samara Regional Clinical Oncology Center ( Site 1117)

Samara, Samara Oblast, 443031, Russia

Location

St.Petersburg Clinical Hospital RAS ( Site 1124)

Saint Petersburg, Sankt-Peterburg, 194017, Russia

Location

Railway Hospital of OJSC ( Site 1122)

Saint Petersburg, Sankt-Peterburg, 195271, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

SPb SBHI City Clinical Oncological Dispensary ( Site 1104)

Saint Petersburg, Sankt-Peterburg, 198255, Russia

Location

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1108)

Kazan', Tatarstan, Respublika, 420029, Russia

Location

Siberian State Medical University ( Site 1121)

Tomsk, Tomsk Oblast, 634028, Russia

Location

Seoul National University Bundang Hospital ( Site 1802)

Seongnam-si, Kyonggi-do, 13620, South Korea

Location

Seoul National University Hospital ( Site 1801)

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System ( Site 1804)

Seoul, 03722, South Korea

Location

Asan Medical Center ( Site 1800)

Seoul, 05505, South Korea

Location

Samsung Medical Center ( Site 1803)

Seoul, 06351, South Korea

Location

Institut Catala d Oncologia Badalona ( Site 1201)

Badalona, Barcelona, 08916, Spain

Location

Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1202)

A Coruña, La Coruna, 15006, Spain

Location

Instituto Valenciano de Oncologia - IVO ( Site 1205)

Valencia, Valenciana, Comunitat, 46009, Spain

Location

Hospital General Universitario de Valencia ( Site 1203)

Valencia, Valenciana, Comunitat, 46014, Spain

Location

Parc de Salut Mar ( Site 1200)

Barcelona, 08003, Spain

Location

Hospital Universitario Reina Sofia ( Site 1207)

Córdoba, 14004, Spain

Location

Hospital Clinico San Carlos ( Site 1209)

Madrid, 28040, Spain

Location

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

Málaga, 29011, Spain

Location

China Medical University Hospital ( Site 1903)

Taichung, 404, Taiwan

Location

Taichung Veterans General Hospital ( Site 1902)

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital ( Site 1904)

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital ( Site 1900)

Taipei, 11217, Taiwan

Location

Linkou Chang Gung Memorial Hospital ( Site 1901)

Taoyuan District, 333, Taiwan

Location

Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi ( Site 1303)

Adana, 01120, Turkey (Türkiye)

Location

Cukurova Uni. Tip Fakultesi ( Site 1302)

Adana, 01330, Turkey (Türkiye)

Location

Gazi Universitesi Tip Fakultesi ( Site 1308)

Ankara, 05600, Turkey (Türkiye)

Location

Baskent Universitesi Ankara Hastanesi ( Site 1300)

Ankara, 06490, Turkey (Türkiye)

Location

Akdeniz Universitesi Tıp Fakultesi ( Site 1301)

Antalya, 07070, Turkey (Türkiye)

Location

Uludag Universitesi Tip Fakultesi ( Site 1307)

Bursa, 16059, Turkey (Türkiye)

Location

Clinical oncology dispensary of Dnipro ( Site 1512)

Dnipro, Dnipropetrovsk Oblast, 49055, Ukraine

Location

City Clinical Hosp.4 of DCC ( Site 1501)

Dnipro, Dnipropetrovsk Oblast, 49102, Ukraine

Location

MI Precarpathian Clinical Oncology Center ( Site 1503)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

Location

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

Kharkiv, Kharkivs’ka Oblast’, 61024, Ukraine

Location

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

Kharkiv, Kharkivs’ka Oblast’, 61070, Ukraine

Location

Khmelnitskiy Regional Onkology Dispensary ( Site 1513)

Khmelnitskiy, Khmelnytskyi Oblast, 29009, Ukraine

Location

Medical Center Asklepion LLC ( Site 1514)

Khodosovka, Kyivska Oblast, 08173, Ukraine

Location

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

Kyiv, Kyivska Oblast, 03022, Ukraine

Location

Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 1507)

Kyiv, Kyivska Oblast, 03126, Ukraine

Location

MI Odessa Regional Oncological Centre ( Site 1504)

Odesa, Odesa Oblast, 65055, Ukraine

Location

Kyiv City Clinical Oncology Centre ( Site 1505)

Kyiv, 03115, Ukraine

Location

Western General Hospital ( Site 1411)

Edinburgh, Edinburgh, City of, EH4 2XU, United Kingdom

Location

UCLH NHS Foundation Trust ( Site 1405)

London, London, City of, NW1 2PG, United Kingdom

Location

Mount Vernon Cancer Centre ( Site 1409)

Northwood, London, City of, HA6 2RN, United Kingdom

Location

Churchill Hospital ( Site 1406)

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

The James Cook University Hospital ( Site 1403)

Middlesbrough, TS4 3BW, United Kingdom

Location

Northern Centre for Cancer Care ( Site 1408)

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 39591551 RESULT

• 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.

  PMID: 41494216 DERIVED

• 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.

  PMID: 34799418 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

lenvatinib; pembrolizumab; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: April 11, 2019
• Primary Completion: October 2, 2023
• Study Completion: February 5, 2025
• Last Updated: February 2, 2026
• Results First Posted: October 16, 2024

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

TU (6); KR (5); ME (6); DE (7); CA (12); JP (18); AU (8); US (29); ES (8); TW (5); PL (8); GB (6); UA (11); BE (5); BR (10); IT (9); AR (6); IE (2); IL (4); CN (16); RU (11)