Clinical trial NCT03884101: Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)
Official title: A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometrial Neoplasms
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Eisai Inc.
First posted: 2019-03-21
Enrollment: 842
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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
timeFrame: Up to approximately 44 months
measure: PFS Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants
timeFrame: Up to approximately 44 months
measure: Overall Survival (OS) in pMMR Participants
timeFrame: Up to approximately 51 months
measure: OS in All Randomized Participants
timeFrame: Up to approximately 51 months
Secondary outcomes:
measure: Objective Response Rate (ORR) Based on RECIST 1.1 as Assessed by BICR in pMMR Participants
timeFrame: Up to approximately 51 months
measure: ORR Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants
timeFrame: Up to approximately 51 months
measure: 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
timeFrame: Baseline and up to approximately 18 weeks
measure: Mean Change From Baseline in the Global Health Status/Quality of Life Score of the EORTC QLQ-C30 in All Randomized Participants
timeFrame: Baseline and up to approximately 18 weeks
measure: Percentage of Participants Experiencing an Adverse Event (AE)
timeFrame: Up to approximately 27 months (through 90 days after the last dose of study treatment)
measure: Percentage of Participants Experiencing a Serious Adverse Event (SAE)
timeFrame: Up to approximately 28 months (through 120 days after the last dose of study treatment)
measure: Percentage of Participants Experiencing an Immune-Related AE (irAE)
timeFrame: Up to approximately 27 months (through 90 days after the last dose of study treatment)
measure: Percentage of Participants Discontinuing From Study Treatment Due to an AE(s)
timeFrame: Up to approximately 24 months (through the last dose of study treatment)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama, Mitchell Cancer Institute ( Site 0245)
state: Alabama
city: Tucson
country: United States
facility: Arizona Oncology Associates PC- HOPE ( Site 8005)
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Hematology and Oncology Clinic (Westwood) ( Site 0233)
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center ( Site 0204)
state: Colorado
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale New Haven ( Site 0202)
state: Connecticut
city: Miami
country: United States
facility: University of Miami Health System ( Site 0249)
state: Florida
city: Augusta
country: United States
facility: Georgia Cancer Center at Augusta University ( Site 0222)
state: Georgia
city: Covington
country: United States
facility: Women's Cancer Care ( Site 0208)
state: Louisiana
city: Scarborough
country: United States
facility: Maine Medical Partners ( Site 0217)
state: Maine
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, PA ( Site 8003)
state: Minnesota
city: Basking Ridge
country: United States
facility: Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 0268)
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0226)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0273)
state: New Jersey
city: Montvale
country: United States
facility: MSKCC-Bergen ( Site 0276)
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center ( Site 0235)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 0267)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Cancer Center - West Harrison ( Site 0274)
state: New York
city: New York
country: United States
facility: The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0206)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center ( Site 0246)
state: New York
city: Rochester
country: United States
facility: University of Rochester ( Site 0238)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Cancer Center - Nassau ( Site 0275)
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina- Chapel Hill ( Site 0254)
state: North Carolina
city: Fargo
country: United States
facility: Roger Maris Cancer Center ( Site 0277)
state: North Dakota
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center ( Site 8004)
state: Oregon
city: Sioux Falls
country: United States
facility: Sanford Cancer Center Oncology Clinic ( Site 0205)
state: South Dakota
city: Dallas
country: United States
facility: Parkland Health & Hospital System ( Site 0272)
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center ( Site 0264)
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology-The Woodlands ( Site 8000)
state: Texas
city: Vancouver
country: United States
facility: Legacy Salmon Creek Medical Center ( Site 0253)
state: Washington
city: Caba
country: Argentina
facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2607)
state: Buenos Aires
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata ( Site 2601)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clinicas Mar del Plata ( Site 2606)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Aleman ( Site 2600)
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires ( Site 2603)
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral ( Site 2605)
city: Camperdown
country: Australia
facility: Chris OBrien Lifehouse ( Site 1605)
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital [Australia] ( Site 1603)
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital ( Site 1600)
state: New South Wales
city: Westmead
country: Australia
facility: The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 1602)
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Misericordiae Ltd ( Site 1608)
state: Queensland
city: Clayton
country: Australia
facility: Monash Health ( Site 1606)
state: Victoria
city: Melbourne
country: Australia
facility: Epworth Freemasons Hospital ( Site 1609)
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital ( Site 1604)
state: Western Australia
city: Graz
country: Austria
facility: Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 3301)
state: Steiermark
city: Innsbruck
country: Austria
facility: Medizinische Universitat Innsbruck ( Site 3302)
state: Tirol
city: Vienna
country: Austria
facility: Medizinische Universitat Wien ( Site 3300)
state: Wien
city: Edegem
country: Belgium
facility: UZA University Hospital Antwerp ( Site 3204)
state: Antwerpen
city: Leuven
country: Belgium
facility: UZ Leuven ( Site 3200)
state: Antwerpen
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc ( Site 3203)
state: Bruxelles-Capitale, Region De
city: Gent
country: Belgium
facility: AZ Maria Middelares Gent ( Site 3202)
state: Oost-Vlaanderen
city: Roeselare
country: Belgium
facility: AZ Delta ( Site 3206)
state: West-Vlaanderen
city: Fortaleza
country: Brazil
facility: Instituto do Cancer do Ceara ( Site 2703)
state: Ceara
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2702)
state: Goias
city: Belo Horizonte
country: Brazil
facility: Faculdade de Medicina da Universidade Federal de Minas Gerais ( Site 2708)
state: Minas Gerais
city: Ijui
country: Brazil
facility: Hospital de Caridade de Ijui ( Site 2712)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 2701)
state: Rio Grande Do Sul
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose de Rio Preto ( Site 2704)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Cancer II ( Site 2707)
city: Sao Paulo
country: Brazil
facility: Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706)
city: Sao Paulo
country: Brazil
facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2713)
city: Sao Paulo
country: Brazil
facility: A.C. Camargo Cancer Center ( Site 2705)
city: Edmonton
country: Canada
facility: Cross Cancer Institute ( Site 0408)
state: Alberta
city: Kelowna
country: Canada
facility: BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0402)
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer-Vancouver Center ( Site 0412)
state: British Columbia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre ( Site 0406)
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre ( Site 0401)
state: Ontario
city: Mississauga
country: Canada
facility: The Credit Valley Hospital ( Site 0403)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute ( Site 0410)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0409)
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0414)
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0411)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre ( Site 0404)
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0417)
state: Quebec
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital ( Site 2509)
state: Anhui
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital Capital Medical University ( Site 2505)
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital ( Site 2501)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 2504)
state: Beijing
city: Chongqing
country: China
facility: Chongqing Cancer Hospital ( Site 2513)
state: Chongqing
city: Guangzhou
country: China
facility: The First Affiliated Hospital.Sun Yat-sen University ( Site 2507)
state: Guangdong
city: Nanning
country: China
facility: Guang Xi Tumour Hospital, Department of Chemotherapy ( Site 2517)
state: Guangxi
city: Wuhan
country: China
facility: Hubei Cancer Hospital ( Site 2510)
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central-South University ( Site 2512)
state: Hunan
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital ( Site 2508)
state: Jiangsu
city: XI An
country: China
facility: The first affiliated Hospital of Xi an Jiaotong University ( Site 2502)
state: Shaanxi
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center ( Site 2500)
state: Shanghai
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hosp. Fudan University ( Site 2503)
state: Shanghai
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University ( Site 2515)
state: Xinjiang
city: Hangzhou
country: China
facility: Women s Hospital School of Medicine Zhejiang University ( Site 2511)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 2506)
state: Zhejiang
city: Mannheim
country: Germany
facility: Universitaetsmedizin Mannheim. Klinik fuer Kinder und Jugendmedizin ( Site 0622)
state: Baden-Wurttemberg
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster ( Site 0615)
state: Baden-Wurttemberg
city: Regensburg
country: Germany
facility: Caritas-Krankenhaus St. Josef Regensburg ( Site 0613)
state: Bayern
city: Wiesbaden
country: Germany
facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0623)
state: Hessen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen ( Site 0616)
state: Nordrhein-Westfalen
city: Jena
country: Germany
facility: Universitaetsklinikum Jena ( Site 0612)
state: Thuringen
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin ( Site 0609)
city: Cork
country: Ireland
facility: Cork University Hospital ( Site 1400)
city: Dublin
country: Ireland
facility: St James Hospital ( Site 1401)
city: Kfar-Saba
country: Israel
facility: Meir Medical Center ( Site 0702)
state: Central
city: Holon
country: Israel
facility: Edith Wolfson Medical Center ( Site 0703)
state: Tell Abib
city: Haifa
country: Israel
facility: Rambam Medical Center ( Site 0700)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center ( Site 0707)
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0800)
state: Emilia-Romagna
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli ( Site 0805)
state: Roma
city: Mestre
country: Italy
facility: Ospedale dell Angelo ( Site 0810)
state: Venezia
city: Arezzo
country: Italy
facility: Medical Oncology Ospedale San Donato ( Site 0812)
city: Bari
country: Italy
facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0801)
city: Bologna
country: Italy
facility: Ospedale Policlinico S. Orsola-Malpighi ( Site 0803)
city: Brindisi
country: Italy
facility: Ospedale Antonio Perrino ( Site 0806)
city: Catania
country: Italy
facility: Azienda Ospedaliera per l Emergenza Cannizzaro ( Site 0807)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 0808)
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 2413)
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 2403)
state: Fukuoka
city: Ota
country: Japan
facility: Gunma Prefectural Cancer Center ( Site 2404)
state: Gunma
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center ( Site 2408)
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Cancer Center ( Site 2414)
state: Hyogo
city: Kawasaki
country: Japan
facility: Nippon Medical School Musashi Kosugi Hospital ( Site 2417)
state: Kanagawa
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital ( Site 2416)
state: Kanagawa
city: Nakagami-gun
country: Japan
facility: University of the Ryukyus Hospital ( Site 2412)
state: Okinawa
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center ( Site 2410)
state: Saitama
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center ( Site 2406)
state: Saitama
city: Tokorozawa
country: Japan
facility: National Defense Medical College Hospital ( Site 2418)
state: Saitama
city: Mitaka
country: Japan
facility: Kyorin University Hospital ( Site 2402)
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 2405)
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 2415)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 2409)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 2401)
city: Tokyo
country: Japan
facility: Showa University Hospital ( Site 2419)
city: Tokyo
country: Japan
facility: Keio University Hospital ( Site 2411)
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 1802)
state: Kyonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 1801)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 1804)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 1800)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 1803)
city: Tuxtla Gutierrez
country: Mexico
facility: Hospital San Lucas Cardiologica del Sureste ( Site 3103)
state: Chiapas
city: Monterrey
country: Mexico
facility: I CAN Oncology SA de SV ( Site 3102)
state: Nuevo Leon
city: Chihuahua
country: Mexico
facility: Centro Estatal de Cancerologia de Chihuahua ( Site 3101)
city: Ciudad de Mexico
country: Mexico
facility: Consultorio Dentro de la Torre Medica Dalinde Oncologia Medica ( Site 3108)
city: Mexico City
country: Mexico
facility: Centro de Investigacion Clinica Gramel ( Site 3107)
city: Mexico City
country: Mexico
facility: Centro Oncologico Internacional. SEDNA ( Site 3106)
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1008)
state: Dolnoslaskie
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki ( Site 1020)
state: Lodzkie
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1019)
state: Malopolskie
city: Warsaw
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1009)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 1011)
state: Mazowieckie
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii ( Site 1005)
state: Podlaskie
city: Gliwice
country: Poland
facility: Centrum Onkologii Instytut im. MSC Oddział w Gliwicach ( Site 1017)
state: Slaskie
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 1004)
state: Wielkopolskie
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Clinical oncology dispensary ( Site 1118)
state: Krasnoyarskiy Kray
city: Moscow
country: Russian Federation
facility: Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1100)
state: Moskva
city: Moscow
country: Russian Federation
facility: FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 1102)
state: Moskva
city: Moscow
country: Russian Federation
facility: Medical Rehabilitation Center ( Site 1101)
state: Moskva
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Oncology Center ( Site 1117)
state: Samarskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: St.Petersburg Clinical Hospital RAS ( Site 1124)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: SPb SBHI City Clinical Oncological Dispensary ( Site 1104)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: Railway Hospital of OJSC ( Site 1122)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1103)
state: Sankt-Peterburg
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1108)
state: Tatarstan, Respublika
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University ( Site 1121)
state: Tomskaya Oblast
city: Badalona
country: Spain
facility: Institut Catala d Oncologia Badalona ( Site 1201)
state: Barcelona
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1202)
state: La Coruna
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia - IVO ( Site 1205)
state: Valenciana, Comunitat
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia ( Site 1203)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Parc de Salut Mar ( Site 1200)
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia ( Site 1207)
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos ( Site 1209)
city: Malaga
country: Spain
facility: Hospital Materno Infantil [Malaga, Spain] ( Site 1208)
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 1903)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 1902)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 1904)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 1900)
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital ( Site 1901)
city: Adana
country: Turkey
facility: Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi ( Site 1303)
city: Adana
country: Turkey
facility: Cukurova Uni. Tip Fakultesi ( Site 1302)
city: Ankara
country: Turkey
facility: Gazi Universitesi Tip Fakultesi ( Site 1308)
city: Ankara
country: Turkey
facility: Baskent Universitesi Ankara Hastanesi ( Site 1300)
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Tıp Fakultesi ( Site 1301)
city: Bursa
country: Turkey
facility: Uludag Universitesi Tip Fakultesi ( Site 1307)
city: Dnipro
country: Ukraine
facility: Clinical oncology dispensary of Dnipro ( Site 1512)
state: Dnipropetrovska Oblast
city: Dnipro
country: Ukraine
facility: City Clinical Hosp.4 of DCC ( Site 1501)
state: Dnipropetrovska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: MI Precarpathian Clinical Oncology Center ( Site 1503)
state: Ivano-Frankivska Oblast
city: Kharkiv
country: Ukraine
facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 1511)
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1509)
state: Kharkivska Oblast
city: Khmelnitskiy
country: Ukraine
facility: Khmelnitskiy Regional Onkology Dispensary ( Site 1513)
state: Khmelnytska Oblast
city: Khodosivka
country: Ukraine
facility: Medical Center Asklepion LLC ( Site 1514)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: National Cancer Institute of the MoH of Ukraine ( Site 1510)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 1507)
state: Kyivska Oblast
city: Odesa
country: Ukraine
facility: MI Odessa Regional Oncological Centre ( Site 1504)
state: Odeska Oblast
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Centre ( Site 1505)
city: Edinburgh
country: United Kingdom
facility: Western General Hospital ( Site 1411)
state: Edinburgh, City Of
city: London
country: United Kingdom
facility: UCLH NHS Foundation Trust ( Site 1405)
state: London, City Of
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre ( Site 1409)
state: London, City Of
city: Oxford
country: United Kingdom
facility: Churchill Hospital ( Site 1406)
state: Oxfordshire
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital ( Site 1403)
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northern Centre for Cancer Care ( Site 1408)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.