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

Primary Purpose

Endometrial Neoplasms

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lenvatinib
Pembrolizumab
Paclitaxel
Carboplatin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Alabama, Mitchell Cancer Institute ( Site 0245)
  • Arizona Oncology Associates PC- HOPE ( Site 8005)
  • UCLA Hematology and Oncology Clinic (Westwood) ( Site 0233)
  • University of Colorado Cancer Center ( Site 0204)
  • Smilow Cancer Hospital at Yale New Haven ( Site 0202)
  • University of Miami Health System ( Site 0249)
  • Georgia Cancer Center at Augusta University ( Site 0222)
  • Women's Cancer Care ( Site 0208)
  • Maine Medical Partners ( Site 0217)
  • Minnesota Oncology Hematology, PA ( Site 8003)
  • Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 0268)
  • John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0226)
  • Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0273)
  • MSKCC-Bergen ( Site 0276)
  • Holy Name Medical Center ( Site 0235)
  • Memorial Sloan-Kettering Cancer Center at Commack ( Site 0267)
  • Memorial Sloan Kettering Cancer Center - West Harrison ( Site 0274)
  • The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0206)
  • Memorial Sloan Kettering Cancer Center ( Site 0246)
  • University of Rochester ( Site 0238)
  • Memorial Sloan Kettering Cancer Center - Nassau ( Site 0275)
  • University of North Carolina- Chapel Hill ( Site 0254)
  • Roger Maris Cancer Center ( Site 0277)
  • Willamette Valley Cancer Institute and Research Center ( Site 8004)
  • Sanford Cancer Center Oncology Clinic ( Site 0205)
  • Parkland Health & Hospital System ( Site 0272)
  • University of Texas Southwestern Medical Center ( Site 0264)
  • Texas Oncology-The Woodlands ( Site 8000)
  • Legacy Salmon Creek Medical Center ( Site 0253)
  • IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2607)
  • Hospital Italiano de La Plata ( Site 2601)
  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 2606)
  • Hospital Aleman ( Site 2600)
  • Hospital Italiano de Buenos Aires ( Site 2603)
  • Centro Oncologico Riojano Integral ( Site 2605)
  • Chris OBrien Lifehouse ( Site 1605)
  • Prince of Wales Hospital [Australia] ( Site 1603)
  • Royal North Shore Hospital ( Site 1600)
  • The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 1602)
  • Mater Misericordiae Ltd ( Site 1608)
  • Monash Health ( Site 1606)
  • Epworth Freemasons Hospital ( Site 1609)
  • Sir Charles Gairdner Hospital ( Site 1604)
  • Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 3301)
  • Medizinische Universitat Innsbruck ( Site 3302)
  • Medizinische Universitat Wien ( Site 3300)
  • UZA University Hospital Antwerp ( Site 3204)
  • UZ Leuven ( Site 3200)
  • Cliniques Universitaires Saint-Luc ( Site 3203)
  • AZ Maria Middelares Gent ( Site 3202)
  • AZ Delta ( Site 3206)
  • Instituto do Cancer do Ceara ( Site 2703)
  • Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2702)
  • Faculdade de Medicina da Universidade Federal de Minas Gerais ( Site 2708)
  • Hospital de Caridade de Ijui ( Site 2712)
  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 2701)
  • Hospital de Base de Sao Jose de Rio Preto ( Site 2704)
  • Instituto Nacional do Cancer II ( Site 2707)
  • Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706)
  • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2713)
  • A.C. Camargo Cancer Center ( Site 2705)
  • Cross Cancer Institute ( Site 0408)
  • BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0402)
  • BC Cancer-Vancouver Center ( Site 0412)
  • Juravinski Cancer Centre ( Site 0406)
  • Kingston Health Sciences Centre ( Site 0401)
  • The Credit Valley Hospital ( Site 0403)
  • Sunnybrook Research Institute ( Site 0410)
  • Princess Margaret Cancer Centre ( Site 0409)
  • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0414)
  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0411)
  • McGill University Health Centre ( Site 0404)
  • CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0417)
  • Anhui Provincial Cancer Hospital ( Site 2509)
  • Beijing Obstetrics and Gynecology Hospital Capital Medical University ( Site 2505)
  • Peking Union Medical College Hospital ( Site 2501)
  • Beijing Cancer Hospital ( Site 2504)
  • Chongqing Cancer Hospital ( Site 2513)
  • The First Affiliated Hospital.Sun Yat-sen University ( Site 2507)
  • Guang Xi Tumour Hospital, Department of Chemotherapy ( Site 2517)
  • Hubei Cancer Hospital ( Site 2510)
  • Xiangya Hospital Central-South University ( Site 2512)
  • Nanjing Maternity and Child Health Care Hospital ( Site 2508)
  • The first affiliated Hospital of Xi an Jiaotong University ( Site 2502)
  • Fudan University Shanghai Cancer Center ( Site 2500)
  • Obstetrics and Gynecology Hosp. Fudan University ( Site 2503)
  • The First Affiliated Hospital of Xinjiang Medical University ( Site 2515)
  • Women s Hospital School of Medicine Zhejiang University ( Site 2511)
  • Zhejiang Cancer Hospital ( Site 2506)
  • Universitaetsmedizin Mannheim. Klinik fuer Kinder und Jugendmedizin ( Site 0622)
  • Universitaetsklinikum Muenster ( Site 0615)
  • Caritas-Krankenhaus St. Josef Regensburg ( Site 0613)
  • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0623)
  • Universitaetsklinikum Essen ( Site 0616)
  • Universitaetsklinikum Jena ( Site 0612)
  • Charite Universitaetsmedizin Berlin ( Site 0609)
  • Cork University Hospital ( Site 1400)
  • St James Hospital ( Site 1401)
  • Meir Medical Center ( Site 0702)
  • Edith Wolfson Medical Center ( Site 0703)
  • Rambam Medical Center ( Site 0700)
  • Chaim Sheba Medical Center ( Site 0707)
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0800)
  • Policlinico Universitario Agostino Gemelli ( Site 0805)
  • Ospedale dell Angelo ( Site 0810)
  • Medical Oncology Ospedale San Donato ( Site 0812)
  • IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0801)
  • Ospedale Policlinico S. Orsola-Malpighi ( Site 0803)
  • Ospedale Antonio Perrino ( Site 0806)
  • Azienda Ospedaliera per l Emergenza Cannizzaro ( Site 0807)
  • Istituto Nazionale Tumori Fondazione Pascale ( Site 0808)
  • Ehime University Hospital ( Site 2413)
  • Kurume University Hospital ( Site 2403)
  • Gunma Prefectural Cancer Center ( Site 2404)
  • National Hospital Organization Hokkaido Cancer Center ( Site 2408)
  • Hyogo Cancer Center ( Site 2414)
  • Nippon Medical School Musashi Kosugi Hospital ( Site 2417)
  • St. Marianna University School of Medicine Hospital ( Site 2416)
  • University of the Ryukyus Hospital ( Site 2412)
  • Saitama Medical University International Medical Center ( Site 2410)
  • Saitama Cancer Center ( Site 2406)
  • National Defense Medical College Hospital ( Site 2418)
  • Kyorin University Hospital ( Site 2402)
  • National Hospital Organization Kyushu Cancer Center ( Site 2405)
  • Niigata Cancer Center Hospital ( Site 2415)
  • Osaka International Cancer Institute ( Site 2409)
  • The Cancer Institute Hospital of JFCR ( Site 2401)
  • Showa University Hospital ( Site 2419)
  • Keio University Hospital ( Site 2411)
  • Seoul National University Bundang Hospital ( Site 1802)
  • Seoul National University Hospital ( Site 1801)
  • Severance Hospital Yonsei University Health System ( Site 1804)
  • Asan Medical Center ( Site 1800)
  • Samsung Medical Center ( Site 1803)
  • Hospital San Lucas Cardiologica del Sureste ( Site 3103)
  • I CAN Oncology SA de SV ( Site 3102)
  • Centro Estatal de Cancerologia de Chihuahua ( Site 3101)
  • Consultorio Dentro de la Torre Medica Dalinde Oncologia Medica ( Site 3108)
  • Centro de Investigacion Clinica Gramel ( Site 3107)
  • Centro Oncologico Internacional. SEDNA ( Site 3106)
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1008)
  • Instytut Centrum Zdrowia Matki Polki ( Site 1020)
  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1019)
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1009)
  • Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 1011)
  • Bialostockie Centrum Onkologii ( Site 1005)
  • Centrum Onkologii Instytut im. MSC Oddział w Gliwicach ( Site 1017)
  • Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 1004)
  • Krasnoyarsk Regional Clinical oncology dispensary ( Site 1118)
  • Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1100)
  • FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 1102)
  • Medical Rehabilitation Center ( Site 1101)
  • Samara Regional Clinical Oncology Center ( Site 1117)
  • St.Petersburg Clinical Hospital RAS ( Site 1124)
  • SPb SBHI City Clinical Oncological Dispensary ( Site 1104)
  • Railway Hospital of OJSC ( Site 1122)
  • National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1103)
  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1108)
  • Siberian State Medical University ( Site 1121)
  • Institut Catala d Oncologia Badalona ( Site 1201)
  • Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1202)
  • Instituto Valenciano de Oncologia - IVO ( Site 1205)
  • Hospital General Universitario de Valencia ( Site 1203)
  • Parc de Salut Mar ( Site 1200)
  • Hospital Universitario Reina Sofia ( Site 1207)
  • Hospital Clinico San Carlos ( Site 1209)
  • Hospital Materno Infantil [Malaga, Spain] ( Site 1208)
  • China Medical University Hospital ( Site 1903)
  • Taichung Veterans General Hospital ( Site 1902)
  • National Taiwan University Hospital ( Site 1904)
  • Taipei Veterans General Hospital ( Site 1900)
  • Linkou Chang Gung Memorial Hospital ( Site 1901)
  • Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi ( Site 1303)
  • Cukurova Uni. Tip Fakultesi ( Site 1302)
  • Gazi Universitesi Tip Fakultesi ( Site 1308)
  • Baskent Universitesi Ankara Hastanesi ( Site 1300)
  • Akdeniz Universitesi Tıp Fakultesi ( Site 1301)
  • Uludag Universitesi Tip Fakultesi ( Site 1307)
  • Clinical oncology dispensary of Dnipro ( Site 1512)
  • City Clinical Hosp.4 of DCC ( Site 1501)
  • MI Precarpathian Clinical Oncology Center ( Site 1503)
  • Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 1511)
  • Communal non profit enterprise Regional Clinical Oncology Center ( Site 1509)
  • Khmelnitskiy Regional Onkology Dispensary ( Site 1513)
  • Medical Center Asklepion LLC ( Site 1514)
  • National Cancer Institute of the MoH of Ukraine ( Site 1510)
  • Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 1507)
  • MI Odessa Regional Oncological Centre ( Site 1504)
  • Kyiv City Clinical Oncology Centre ( Site 1505)
  • Western General Hospital ( Site 1411)
  • UCLH NHS Foundation Trust ( Site 1405)
  • Mount Vernon Cancer Centre ( Site 1409)
  • Churchill Hospital ( Site 1406)
  • The James Cook University Hospital ( Site 1403)
  • Northern Centre for Cancer Care ( Site 1408)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lenvatinib + Pembrolizumab

Paclitaxel + Carboplatin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
Progression-free survival based on RECIST 1.1 as assessed by BICR. Progression-free survival is measured from the time of randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Overall Survival (OS)
Overall survival is measured from the time of randomization up to death due to any cause.

Secondary Outcome Measures

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

Full Information

First Posted
March 19, 2019
Last Updated
September 29, 2023
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03884101
Brief Title
Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)
Acronym
LEAP-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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 11, 2019 (Actual)
Primary Completion Date
November 4, 2023 (Anticipated)
Study Completion Date
April 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
Eisai Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
875 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lenvatinib + Pembrolizumab
Arm Type
Experimental
Arm Description
Participants receive lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
Arm Title
Paclitaxel + Carboplatin
Arm Type
Active Comparator
Arm Description
Participants receive paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
E7080, MK-7902, LENVIMA®
Intervention Description
Lenvatinib 4 mg or 10 mg capsules at a total daily dose of 20 mg taken by mouth once per day.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
Pembrolizumab 200 mg IV infusion given on Day 1 of each cycle.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
TAXOL®, ONXAL®
Intervention Description
Paclitaxel 175 mg/m^2 IV infusion given on Day 1 of each cycle.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
PARAPLATIN®
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
Progression-free survival based on RECIST 1.1 as assessed by BICR. Progression-free survival is measured from the time of randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 31 months
Title
Overall Survival (OS)
Description
Overall survival is measured from the time of randomization up to death due to any cause.
Time Frame
Up to approximately 45 months
Secondary Outcome Measure Information:
Title
Objective response rate (ORR ) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent review (BICR)
Description
The ORR (either confirmed complete response [CR] or partial response [PR]) based on RECIST 1.1 and assessed by BICR will be determined in mismatch repair proficient (pMMR) participants and in all-comer participants who have measurable disease at study entry.
Time Frame
Up to approximately 31 months
Title
Mean change from baseline in the global health status/quality of life score of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) in pMMR and in all-comer participants
Description
The EORTC QLQ-C30 was developed to assess the quality of life of patients with cancer. It contains 30 questions (items), 24 of which aggregate into nine multi-item scales representing various aspects, or dimensions, of quality of life (QoL): one global scale, five functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea, pain), and six additional single-symptom items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Individual items are scored on a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Raw scores for each scale are standardized into a range of 0 to 100 by linear transformation; a higher score on the global and functional scales represents a higher ("better") level of functioning, and a higher score on the symptom scale represents a higher ("worse") level of symptoms.
Time Frame
Baseline and designated time points up to 27 months
Title
Percentage of participants experiencing an adverse event (AE)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time Frame
Up to approximately 27 months (through 90 days after the last dose of study treatment)
Title
Percentage of participants experiencing a serious adverse event (SAE)
Description
An SAE is an AE that results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability, is a congenital birth defect, or is another important medical event.
Time Frame
Up to approximately 28 months (through 120 days after the last dose of study treatment)
Title
Percentage of participants experiencing an immune-related AE (irAE)
Description
Immune-related AEs will be monitored in both arms.
Time Frame
Up to approximately 27 months (through 90 days after the last dose of study treatment)
Title
Percentage of participants discontinuing from study treatment due to an AE(s)
Description
Discontinuations related to AEs will be monitored in both arms.
Time Frame
Up to approximately 24 months (through the last dose of study treatment)

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
34799418
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.
Results Reference
derived
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=7902-001&&kw=7902-001
Description
Plain Language Summary

Learn more about this trial

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

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