Clinical Trial - NCT03517449

Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])

Recruiting

Sponsor: Eisai Inc.

Collaborators: Merck Sharp & Dohme Corp.

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03517449

Protocol Info

Short Description: Lenvatinib + Pembrolizumab in Endometial Cancer
Long Description: A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Pembrolizumab Versus Treatment of Physician's Choice in Participants with Advanced Endometrial Cancer
MGH Status: Open
Sponsor: Merck
Disease Program: GYN

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician's choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician's choice.
Condition Title Intervention Phase
Endometrial Neoplasms Pembrolizumab Lenvatinib Paclitaxel Doxorubicin Phase 3
Study Type Interventional
Official Title A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer

Primary Outcome Measures

Progression Free Survival (PFS) [Time Frame: Up to approximately 24 months] [Designated as safety issue: ]

Overall Survival (OS) [Time Frame: Up to approximately 27 months] [Designated as safety issue: ]


Secondary Outcome Measures

Objective Response Rate (ORR) [Time Frame: Up to approximately 24 months] [Designated as safety issue: ]

Health-Related Quality of Life (HRQoL) Score Using the European Organization for Research and Treatment (EORTC) Quality of Life (QoL) Questionnaire (QLQ-C30) Version 3.0 [Time Frame: Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and at the end of follow-up (up to approximately 27 months)] [Designated as safety issue: ]

Number of Participants With Adverse Events (AE) [Time Frame: Up to approximately 27 months] [Designated as safety issue: ]

Number of Participants With Serious Adverse Events (SAE) [Time Frame: Up to approximately 27 months] [Designated as safety issue: ]

Number of Participants With Immune-related Adverse Events (irAE) [Time Frame: Up to approximately 27 months] [Designated as safety issue: ]

Number of Participants With Treatment Discontinuations Due to AEs [Time Frame: Up to approximately 27 months] [Designated as safety issue: ]

Time to Treatment Failure (TTF) Due to Treatment Emergent AEs [Time Frame: Up to approximately 27 months] [Designated as safety issue: ]

Area Under the Concentration time Curve of Lenvatinib From Time 0 to Infinity (AUC 0-∞) [Time Frame: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 15: predose and 2-12 hours postdose; Cycle 2 Day 1: predose and 0.5 - 4 hours and 6-10 hours postdose; Cycle length = 21 days] [Designated as safety issue: ]

Apparent Total Body Clearance (Cl/F) of Lenvatinib [Time Frame: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 15: predose and 2-12 hours postdose; Cycle 2 Day 1: predose and 0.5 - 4 hours and 6-10 hours postdose; Cycle length = 21 days] [Designated as safety issue: ]

Apparent Total Body Volume of Distribution (Vd/F) of Lenvatinib [Time Frame: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 15: predose and 2-12 hours postdose; Cycle 2 Day 1: predose and 0.5 - 4 hours and 6-10 hours postdose; Cycle length = 21 days] [Designated as safety issue: ]

Estimated Enrollment: 780
Study Start Date: June 2018
Estimated Study Completion Date: January 2023
Estimated Primary Completion Date: February 2022
Arms Assigned Interventions

Experimental:Lenvatinib 20 mg + Pembrolizumab 200 mg

Participants will receive pembrolizumab 200 milligram (mg) administered by intravenous (IV) infusion on Day 1 of each 21-day cycle plus lenvatinib 20 mg administered orally (PO) once daily (QD) during each 21-day cycle for up to 35 cycles.
Drug:Lenvatinib
20 mg administered orally (PO) QD during each 21-day cycle.

Active Comparator:Treatment of Physician's Choice

Participants will receive either of the following treatments: doxorubicin 60 milligram per square meter (mg/m^2) administered by IV on Day 1 of each 21-day cycle for up to a maximum cumulative dose of 500 mg/m^2 OR paclitaxel 80 mg/m^2 administered by IV on a 28-day cycle: 3 weeks receiving paclitaxel once a week and 1 week not receiving paclitaxel.
Drug:Doxorubicin
60 mg/m^2 administered by IV on Day 1 of each 21-day cycle.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: Female

Accepts Healthly Volunteers: No

Inclusion Criteria:

1. Has a histologically confirmed diagnosis of endometrial carcinoma (EC)

2. Documented evidence of advanced, recurrent or metastatic EC.

3. Has radiographic evidence of disease progression after 1 prior systemic, platinum-based chemotherapy regimen for EC. Participants may have received up to 1 additional line of platinum-based chemotherapy if given in the neoadjuvant or adjuvant treatment setting.

Note: There is no restriction regarding prior hormonal therapy.

4. Has historical or fresh tumor biopsy specimen for determination of mismatch repair (MMR) status.

5. Has at least 1 measurable target lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and confirmed by Blinded Independent Central Review BICR.

6. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.

7. Is not pregnant, breastfeeding, and agrees to use a highly effective method of contraception during the treatment period and for at least 120 days (for participants treated with lenvatinib plus pembrolizumab) or at least 180 days (for participants treated with treatment of physician's choice [TPC]) after the last dose of study treatment.

Exclusion Criteria:

1. Has carcinosarcoma (malignant mixed mullerian tumor), endometrial leiomyosarcoma and endometrial stromal sarcomas.

2. Has unstable central nervous system (CNS) metastases.

3. Has active malignancy (except for endometrial cancer, definitively treated in-situ carcinomas [e.g. breast, cervix, bladder], or basal or squamous cell carcinoma of the skin) within 24 months of study start.

4. Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.

5. Has a pre-existing greater than or equal (>=) Grade 3 gastrointestinal or non-gastrointestinal fistula.

6. Has radiographic evidence of major blood vessel invasion/infiltration.

7. Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment.

8. Has a history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction, cerebrovascular accident (CVA) stroke, or cardiac arrhythmia associated with hemodynamic instability within 12 months of the first dose of study treatment.

9. Has an active infection requiring systemic treatment.

10. Has not recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy.

11. Is positive for Human Immunodeficiency Virus (HIV).

12. Has active Hepatitis B or C.

13. Has a history of (non-infectious) pneumonitis that required treatment with steroids, or has current pneumonitis.

14. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.

15. 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 study start -Has an active autoimmune disease (with the exception of psoriasis) that has required systemic treatment in the past 2 years.

16. Is pregnant or breastfeeding.

17. Has had an allogenic tissue/solid organ transplant.

18. Has received >1 prior systemic chemotherapy regimen (other than adjuvant or neoadjuvant) for Endometrial Cancer. Participants may receive up to 2 regimens of platinum-based chemotherapy in total, as long as one is given in the neoadjuvant or adjuvant treatment setting.

19. Has received prior anticancer treatment within 28 days of study start. All acute toxicities related to prior treatments must be resolved to Grade ≤1, except for alopecia and Grade ≤2 peripheral neuropathy.

20. Has received prior treatment with any treatment targeting VEGF-directed angiogenesis, any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.

21. Has received prior treatment with an agent directed to a stimulatory or co-inhibitory T-cell receptor other than an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, and who has discontinued from that treatment due to a Grade 3 or higher immune-related adverse event.

22. Has received prior radiation therapy within 21 days of study start with the exception of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks of study start. Participants must have recovered from all radiation-related toxicities and/or complications prior to randomization.

23. Has received a live vaccine within 30 days of study start.

24. Has a known intolerance to study treatment (or any of the excipients).

25. Prior enrollment on a clinical study evaluating pembrolizumab and lenvatinib for endometrial carcinoma, regardless of treatment received.

26. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks of study start.

27. Participants with urine protein ≥1 gram (g)/24 hour.

28. Prolongation of corrected QT (QTc) interval to >480 milliseconds (ms).

29. Left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03517449

Locations

  • United States, Arizona
    • Arizona Oncology Associates, PC- HAL Phoenix, Arizona, United States, 85016
  • United States, California
    • University of California San Francisco San Francisco, California, United States, 94158
    • University of California Los Angeles Santa Monica, California, United States, 90095
  • United States, Connecticut
    • Smilow Cancer Hospital at Yale New Haven New Haven, Connecticut, United States, 06510
  • United States, Florida
    • University of Miami Health System Miami, Florida, United States, 33136
    • Florida Hospital Cancer Institute Orlando, Florida, United States, 32804
  • United States, Georgia
    • Georgia Cancer Center at Augusta University Augusta, Georgia, United States, 30912
  • United States, Illinois
    • North Shore University Health System Evanston, Illinois, United States, 60201
    • Midwestern Regional Medical Center Zion, Illinois, United States, 60099
  • United States, Louisiana
    • University Medical Center New Orleans New Orleans, Louisiana, United States, 70112
  • United States, Maryland
    • Greater Baltimore Medical Center Baltimore, Maryland, United States, 21204
    • Maryland Oncology Hematology, P.A. Wheaton, Maryland, United States, 20902
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
  • United States, New Jersey
    • John Theurer Cancer Center at Hackensack University Med Ctr Hackensack, New Jersey, United States, 07601
    • Holy Name Medical Center Teaneck, New Jersey, United States, 07666
  • United States, New York
    • Memorial Sloan Kettering Cancer Center New York, New York, United States, 10020
    • University of Rochester Rochester, New York, United States, 14642
  • United States, North Carolina
    • Duke University Medical Center Durham, North Carolina, United States, 27710
  • United States, Oklahoma
    • Stephenson Cancer Center Oklahoma City, Oklahoma, United States, 73104
  • United States, Oregon
    • Willamette Valley Cancer Institute and Research Center Eugene, Oregon, United States, 97401
  • United States, South Dakota
    • Sanford Gynecology Oncology Sioux Falls, South Dakota, United States, 57104
  • United States, Tennessee
    • UT West Cancer Center Germantown, Tennessee, United States, 38138
  • United States, Texas
    • Texas Oncology-South Austin Austin, Texas, United States, 78745
    • University of Texas Southwestern Medical Center at Dallas Dallas, Texas, United States, 75390-9032
    • The University of Texas MD Anderson Cancer Center Houston, Texas, United States, 77030
    • Texas Oncology-San Antonio Medical Center San Antonio, Texas, United States, 78240
  • United States, Utah
    • Utah Cancer Specialists Salt Lake City, Utah, United States, 84106
  • Argentina, Buenos Aires
    • Centro de Oncologia e Investigacion Buenos Aires COIBA Berazategui, Buenos Aires, Argentina, B1884BBF
    • Hospital Privado de la Comunidad Mar del Plata, Buenos Aires, Argentina, B7602CBM
  • Argentina,
    • Hospital Aleman Buenos Aires, , Argentina, C1118AAT
    • Sanatorio Guemes Buenos Aires, , Argentina, C1180AAX
    • Instituto de Oncologia Angel H. Roffo Buenos Aires, , Argentina, C1417DTB
    • Instituto Medico Especializado Alexander Fleming Buenos Aires, , Argentina, C1426ANZ
    • Centro Oncologico Riojano Integral La Rioja, , Argentina, F5300COE
  • Australia, New South Wales
    • Royal North Shore Hospital St Leonards, New South Wales, Australia, 2065
  • Australia, Queensland
    • Royal Brisbane and Women s Hospital Herston, Queensland, Australia, 4029
  • Australia, South Australia
    • Flinders Medical Centre Bedford Park, South Australia, Australia, 5042
  • Australia, Victoria
    • Peter MacCallum Cancer Centre Melbourne, Victoria, Australia, 3000
  • Australia, Western Australia
    • St John of God Subiaco, Western Australia, Australia, 6008
  • Brazil, GO
    • Hospital Araujo Jorge Goiania, GO, Brazil, 74175-120
  • Brazil, RJ
    • Instituto Nacional do Cancer II Rio de Janeiro, RJ, Brazil, 20220-410
  • Brazil, RS
    • Hospital de Clinicas de Porto Alegre Porto Alegre, RS, Brazil, 90035-903
    • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs Porto Alegre, RS, Brazil, 90610-000
  • Brazil, SP
    • Fundacao Dr Amaral Carvalho Jau, SP, Brazil, 17210-080
    • Instituto do Cancer de Sao Paulo - ICESP Sao Paulo, SP, Brazil, 01246-000
    • Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda Sao Paulo, SP, Brazil, 01317-000
  • Brazil,
    • Faculdade de Medicina da Universidade Federal de Minas Gerais Belo Horizonte, , Brazil, 30130-100
  • Canada, Alberta
    • Tom Baker Cancer Centre Calgary, Alberta, Canada, T2N 4N2
  • Canada, Manitoba
    • Cancer Care Manitoba Winnipeg, Manitoba, Canada, R3E 0V9
  • Canada, Ontario
    • London Health Sciences Centre London, Ontario, Canada, N6A 5A5
    • Ottawa General Hospital Ottawa, Ontario, Canada, K1H 8L6
    • Sunnybrook Health Science Centre Toronto, Ontario, Canada, M4N 3M5
    • Princess Margaret Cancer Centre Toronto, Ontario, Canada, M5G 2M9
  • Canada, Quebec
    • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont Montreal, Quebec, Canada, H1T 2M4
    • Centre Hospitalier de l Universite de Montreal - CHUM Montreal, Quebec, Canada, H2X 3E4
    • Jewish General Hospital Montreal, Quebec, Canada, H3T 1E2
    • CIUSSS de l'Estrie-CHUS Sherbrooke, Quebec, Canada, J1H 5N4
  • Canada,
    • CHU de Quebec-Universite Laval-Hotel Dieu de Quebec Quebec, , Canada, G1R 2J6
  • Colombia, Cundinamarca
    • Clinica del Country Bogota, Cundinamarca, Colombia, 110221
  • Colombia, Valle Del Cauca
    • Fundacion Valle del Lili Cali, Valle Del Cauca, Colombia, 760032
  • Colombia,
    • Clinica Colsanitas S.A. - Sede Clinica Universitaria Colombia Bogota, , Colombia, 111321
    • Rodrigo Botero SAS Medellin, , Colombia, 50015
    • Fundacion Colombiana de Cancerologia Clinica Vida Medellin, , Colombia, 50032
    • Oncomedica S.A. Monteria, , Colombia, 111511
  • France,
    • Institut Bergonie Bordeaux, , France, 33076
    • Centre de Lutte Contre le Cancer Francois Baclesse Caen, , France, 14000
    • Centre Oscar Lambret Lille, , France, 59020
    • Centre Leon Berard Lyon, , France, 69000
    • Institut Regional du Cancer de Montpellier - ICM Montpellier, , France, 34298
    • Hopital prive du Confluent Nantes, , France, 44277
    • Hopital Diaconesses Croix Saint Simon Paris, , France, 75020
    • Groupe Hospitalier Broca Cochin Hotel Dieu Paris, , France, 75679
    • Centre Hospitalier Lyon Sud Pierre Benite, , France, 69495
    • Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie Plerin, , France, 22190
    • Centre Eugene Marquis Rennes, , France, 35042
    • Institut Gustave Roussy Villejuif, , France, 94800
  • Germany,
    • EISAI Trial Site 4 Berlin, , Germany,
    • EISAI Trial Site 2 Dresden, , Germany,
    • EISAI Trial Site 1 Erlangen, , Germany,
    • EISAI Trial Site 6 Hamburg, , Germany,
    • EISAI Trial Site 3 Rostock, , Germany,
    • EISAI Trial Site 5 Tuebingen, , Germany,
  • Ireland,
    • Mater Misericordiae University Hospital Dublin, , Ireland, D07 R2WY
    • University College Hospital of Galway Galway, , Ireland, H91 YR71
  • Israel,
    • Soroka Medical Center Beer Sheva, , Israel, 84101
    • Rambam Medical Center Haifa, , Israel, 3525408
    • Edith Wolfson Medical Center Holon, , Israel, 5822012
    • Rabin Medical Center Petah Tikva, , Israel, 4941492
    • Chaim Sheba Medical Center Ramat Gan, , Israel, 5262000
  • Italy,
    • Azienda Ospedaliera per l Emergenza Cannizzaro Catania, , Italy, 95126
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola, , Italy, 47014
    • Ospedale San Raffaele Milano, , Italy, 20132
    • Istituto Europeo di Oncologia Milano, , Italy, 20141
    • Fondazione IRCCS Istituto Nazionale dei Tumori Milan, , Italy, 20133
    • Istituto Nazionale Tumori IRCCS Fondazione Pascale Napoli, , Italy, 80131
    • Policlinico Universitario Agostino Gemelli Roma, , Italy, 168
  • Japan, Aichi
    • EISAI Trial Site 9 Nagoya, Aichi, Japan,
  • Japan, Chiba
    • EISAI Trial Site 18 Kashiwa, Chiba, Japan,
  • Japan, Ehime
    • EISAI Trial Site 7 Matsuyama, Ehime, Japan,
    • EISAI Trial Site 15 Toon, Ehime, Japan,
  • Japan, Fukuoka
    • EISAI Trial Site 5 Kurume, Fukuoka, Japan,
  • Japan, Hokkaido
    • EISAI Trial Site 11 Sapporo, Hokkaido, Japan,
  • Japan, Hyogo
    • EISAI Trial Site 8 Akashi, Hyogo, Japan,
  • Japan, Ibaraki
    • EISAI Trial Site 17 Tsukuba, Ibaraki, Japan,
  • Japan, Iwate
    • EISAI Trial Site 4 Morioka, Iwate, Japan,
  • Japan, Kanagawa
    • EISAI Trial Site 19 Isehara, Kanagawa, Japan,
  • Japan, Miyagi
    • EISAI Trial Site 14 Sendai, Miyagi, Japan,
  • Japan, Saitama
    • EISAI Trial Site 1 Hidaka, Saitama, Japan,
  • Japan, Shizuoka
    • EISAI Trial Site 2 Sunto-gun, Shizuoka, Japan,
  • Japan,
    • EISAI Trial Site 16 Kagoshima, , Japan,
    • EISAI Trial Site 3 Niigata, , Japan,
    • EISAI Trial Site 10 Tokyo, , Japan,
    • EISAI Trial Site 12 Tokyo, , Japan,
    • EISAI Trial Site 13 Tokyo, , Japan,
    • EISAI Trial Site 6 Tokyo, , Japan,
  • Korea, Republic of, Gyeonggi-do
    • National Cancer Center Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
  • Korea, Republic of,
    • Seoul National University Hospital Seoul, , Korea, Republic of, 3080
    • Asan Medical Center Seoul, , Korea, Republic of, 5505
    • Samsung Medical Center Seoul, , Korea, Republic of, 6351
  • Mexico, Nuevo Leon
    • Alivia Clinica de Alta Especialidad S.A. de C.V. Monterrey, Nuevo Leon, Mexico, 64060
  • Mexico,
    • Investigacion Onco Farmaceutica S de RL de CV La Paz, , Mexico, 23040
    • Grupo Medico Camino SC Mexico City, , Mexico, 3310
    • Centro Hemato Oncologico Privado Toluca, , Mexico, 50080
    • Faicic S de RL de CV Veracruz, , Mexico, 91900
  • New Zealand,
    • Auckland City Hospital Auckland, , New Zealand, 1023
  • Poland, Malopolskie
    • Centrum Onkologii Instytut im. Marii Sklodowskiej Curie Krakow, Malopolskie, Poland, 31-115
  • Poland, Mazowieckie
    • Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie Warszawa, Mazowieckie, Poland, 02-781
  • Poland, Pomorskie
    • Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o. Gdynia, Pomorskie, Poland, 81-159
  • Poland,
    • Beskidzkie Centrum Onkologii im. Jana Pawla II Bielsko-Biala, , Poland, 43-300
    • Centrum Onkologii Instytut im. Marii Sklodowskiej Curie Gliwice, , Poland, 44-101
    • Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego Katowice, , Poland, 40-514
    • Pomorski Uniwersytet Medyczny w Szczecinie Szczecin, , Poland, 70-111
    • Szpital Kliniczny im Ks Anny Mazowieckiej Warszawa, , Poland, 00-315
  • Russian Federation,
    • Altay Regional Oncology Dispensary Barnaul, , Russian Federation, 656049
    • Republican Clinical Oncology Dispensary of Tatarstan MoH Kazan, , Russian Federation, 420029
    • SBHI Clin Oncological Dispensary N1 of MoH of Krasnodar Region Krasnodar, , Russian Federation, 350040
    • FSBI National Medical Oncology Research Center n.a. N.N. Blokhina Moscow, , Russian Federation, 115478
    • FSBI-FRCC of Special Types Med. Care & Technologies FMBA of Russia Moscow, , Russian Federation, 115682
    • SPb SBHI City Clinical Oncological Dispensary Saint Petersburg, , Russian Federation, 198255
    • Leningrad Regional Oncology Center Saint-Petersburg, , Russian Federation, 191014
    • Mordovia Republican Oncological Dispensary Saransk, , Russian Federation, 430032
    • Tomsk National Research Medical Center of Russian Academy of Sciences Tomsk, , Russian Federation, 624028
    • Republican Clinical Oncology Dispensary of Republic of Bashkortostan Ufa, , Russian Federation, 450054
  • Spain, Barcelona
    • Hospital Germans Trias i Pujol. ICO de Badalona Badalona, Barcelona, Spain, 08916
    • Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals Hospitalet de Llobregat, Barcelona, Spain, 8908
  • Spain,
    • Hospital General Universitari Vall d Hebron Barcelona, , Spain, 8035
    • Hospital Universitario Gregorio Maranon Madrid, , Spain, 28007
    • Clinica Universitaria Navarra - Madrid Madrid, , Spain, 28022
    • Hospital Ramon y Cajal Madrid, , Spain, 28034
    • Hospital Clinico San Carlos Madrid, , Spain, 28040
    • Hospital Universitario 12 de Octubre Madrid, , Spain, 28041
    • Hospital Universitario La Paz Madrid, , Spain, 28046
    • Clinica Universitaria de Navarra Pamplona, , Spain, 31008
    • Hospital Universitario y Politecnico La Fe de Valencia Valencia, , Spain, 46026
  • Taiwan, Beitou
    • Taipei Veterans General Hospital Taipei, Beitou, Taiwan, 11217
  • Taiwan,
    • Kaohsiung Veterans General Hospital Kaohsiung, , Taiwan, 813
    • Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F. Kaohsiung, , Taiwan, 83301
    • Taichung Veterans General Hospital Taichung, , Taiwan, 40705
    • National Taiwan University Hospital Taipei, , Taiwan, 10002
    • Chang Gung Medical Foundation. Linkou Branch Taoyuan, , Taiwan, 33305
  • Turkey,
    • Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi Adana, , Turkey, 1250
    • Baskent Universitesi Ankara Hastanesi Ankara, , Turkey, 6000
    • Hacettepe University Medical Faculty Ankara, , Turkey, 6000
    • Acibadem Bursa Hastanesi Bursa, , Turkey, 16110
    • Acibadem Universitesi Atakent Hastanesi Istanbul, , Turkey, 34303
    • Florence Nightingale Gayrettepe Hastanesi Istanbul, , Turkey, 34349
    • Ege Universitesi Tip Fakultesi Izmir, , Turkey, 35040
  • United Kingdom,
    • Royal Sussex County Hospital Brighton, , United Kingdom, BN2 5BE
    • Addenbrookes Hospital Cambridge, , United Kingdom, CB2 0QQ
    • Western General Hospital Edinburgh, , United Kingdom, EH4 2XU
    • Barts Health NHS Trust - St Bartholomew s Hospital London, , United Kingdom, EC1A 7BE
    • Guy s & St Thomas NHS Foundation Trust London, , United Kingdom, SE1 9RT
    • The Royal Marsden Foundation Trust London, , United Kingdom, SM2 5PT
    • The Royal Marsden NHS Foundation Trust London, , United Kingdom, SW3 6JJ
    • Imperial College Healthcare NHS Trust London, , United Kingdom, W12 0HS
    • University College Hospital London, , United Kingdom, WC1E 6AG
    • University Hospital Southampton NHS Foundation Trust Southampton, , United Kingdom, SO16 6YD

Sponsors and Collaborators

Eisai Inc.

Merck Sharp & Dohme Corp.

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03517449
Other Study ID Numbers: 2017-004387-35
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Eisai Inc.:

programmed cell death 1 (PD-1, PD1)

programmed cell death ligand 1 (PD-L1, PDL1)

programmed cell death ligand 2 (PD-L2, PDL2)

vascular endothelial growth factor (VEGF) receptors

lenvatinib

pembrolizumab

doxorubicin

paclitaxel

phase 3 endometrial cancer

Additional relevant MeSH terms:

Endometrial Neoplasms

Paclitaxel

Albumin-Bound Paclitaxel

Pembrolizumab

Doxorubicin

Liposomal doxorubicin

Lenvatinib

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on August 15, 2019