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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])

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ClinicalTrials.gov Identifier: NCT03517449
Recruitment Status : Recruiting
First Posted : May 7, 2018
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Eisai Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Endometrial Neoplasms Drug: Pembrolizumab Drug: Lenvatinib Drug: Paclitaxel Drug: Doxorubicin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : February 24, 2022
Estimated Study Completion Date : January 25, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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: Pembrolizumab
200 mg administered by IV infusion on Day 1 of each 21-day cycle.
Other Names:
  • KEYTRUDA®
  • MK-3475

Drug: Lenvatinib
20 mg administered orally (PO) QD during each 21-day cycle.
Other Name: LENVIMA®

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: 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.
Other Names:
  • TAXOL®
  • ABRAXANE®

Drug: Doxorubicin
60 mg/m^2 administered by IV on Day 1 of each 21-day cycle.
Other Names:
  • DOXIL®
  • ADRIAMYCIN®




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Up to approximately 24 months ]
    PFS is defined as the time from randomization to the first documented disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurred first.

  2. Overall Survival (OS) [ Time Frame: Up to approximately 27 months ]
    OS is defined as the time from date of randomization to date of death from any cause.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to approximately 24 months ]
    ORR is defined as the percentage of participants who have best overall response of either complete response (CR) or partial response (PR), as determined by BICR per RECIST 1.1.

  2. 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) ]
    Change from baseline in HRQoL using the global score of EORTC QLQ-C30 will be determined. EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, which contains 30 items and measures 5 functional dimensions (physical, role, emotional, cognitive, and social), 3 symptom items (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and QoL scale. The score for each item and the overall score ranges from 0 to 100. A high overall scale and subscale scores represent improved health status. However, in case of individual symptoms, higher scores suggest increased perception of these symptoms of life.

  3. Number of Participants With Adverse Events (AE) [ Time Frame: Up to approximately 27 months ]
    The number of participants experiencing an AE will be assessed. An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.

  4. Number of Participants With Serious Adverse Events (SAE) [ Time Frame: Up to approximately 27 months ]
    The number of participants experiencing an SAE will be assessed. A SAE is an AE that results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is associated with an overdose, or is another important medical event.

  5. Number of Participants With Immune-related Adverse Events (irAE) [ Time Frame: Up to approximately 27 months ]
    The number of participants experiencing an irAE will be assessed. An irAE is defined as any unfavorable and unintended immune-related sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.

  6. Number of Participants With Treatment Discontinuations Due to AEs [ Time Frame: Up to approximately 27 months ]
    The number of participants who discontinue study treatment due to an AE will be assessed.

  7. Time to Treatment Failure (TTF) Due to Treatment Emergent AEs [ Time Frame: Up to approximately 27 months ]
    Time to treatment failure due to toxicity, defined as the time from the date of randomization to the date that a participant discontinues study treatment due to AEs.

  8. 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 ]
  9. 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 ]
  10. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has a histologically confirmed diagnosis of endometrial carcinoma (EC) and documented evidence of advanced, recurrent or metastatic EC.
  2. Has radiographic evidence of disease progression after 1 prior systemic, platinum-based chemotherapy regimen for recurrent, metastatic or primary unresectable disease.
  3. Has historical or fresh tumor biopsy specimen for determination of mismatch repair (MMR) status.
  4. 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.
  5. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days of study start.
  6. Is not pregnant, breastfeeding, and agrees to use a highly effective method of contraception during the treatment period and for at least 120 days 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 radiographic evidence of major blood vessel invasion/infiltration.
  6. Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment.
  7. 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.
  8. Has an active infection requiring systemic treatment.
  9. Has not recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy.
  10. Is positive for Human Immunodeficiency Virus (HIV).
  11. Has active Hepatitis B or C.
  12. Has a history of (non-infectious) pneumonitis that required treatment with steroids, or has current pneumonitis.
  13. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
  14. 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.
  15. Is pregnant or breastfeeding.
  16. Has received >1 prior systemic anticancer regimen (other than adjuvant or neoadjuvant) for advanced, recurrent, or metastatic EC.
  17. 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.
  18. Has received prior treatment with any treatment targeting VEGF-directed angiogenesis, any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  19. 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.
  20. 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.
  21. Has received a live vaccine within 30 days of study start.
  22. Has a known intolerance to study treatment (or any of the excipients).
  23. 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.
  24. Participants with urine protein ≥1 gram (g)/24 hour.
  25. Prolongation of corrected QT (QTc) interval to >480 milliseconds (ms).
  26. Left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517449


Contacts
Contact: Eisai Medical Info 1-888-274-2378 esi_medinfo@eisai.com

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

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT03517449     History of Changes
Other Study ID Numbers: E7080-G000-309
2017-004387-35 ( EudraCT Number )
MK3475-775 ( Other Identifier: Merck Protocol Number )
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Liposomal doxorubicin
Pembrolizumab
Lenvatinib
Albumin-Bound Paclitaxel
Doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Protein Kinase Inhibitors