search
Back to results

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])

Primary Purpose

Endometrial Neoplasms

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Lenvatinib
Paclitaxel
Doxorubicin
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Neoplasms focused on measuring 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

Eligibility Criteria

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

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).

Sites / Locations

  • Arizona Oncology Associates, PC- HAL
  • University of California San Francisco
  • University of California Los Angeles
  • Smilow Cancer Hospital at Yale New Haven
  • University of Miami Health System
  • Florida Hospital Cancer Institute
  • Georgia Cancer Center at Augusta University
  • North Shore University Health System
  • University Medical Center New Orleans
  • Greater Baltimore Medical Center
  • Maryland Oncology Hematology, P.A.
  • John Theurer Cancer Center at Hackensack University Med Ctr
  • Holy Name Medical Center
  • Memorial Sloan Kettering Cancer Center
  • University of Rochester
  • Duke University Medical Center
  • Stephenson Cancer Center
  • Willamette Valley Cancer Institute and Research Center
  • Sanford Gynecology Oncology
  • UT West Cancer Center
  • Texas Oncology-South Austin
  • University of Texas Southwestern Medical Center at Dallas
  • The University of Texas MD Anderson Cancer Center
  • Texas Oncology-San Antonio Medical Center
  • Utah Cancer Specialists
  • Centro de Oncologia e Investigacion Buenos Aires COIBA
  • Hospital Privado de la Comunidad
  • Instituto de Investigaciones Metabolicas
  • Hospital Aleman
  • Instituto de Oncologia Angel H. Roffo
  • Instituto Medico Especializado Alexander Fleming
  • Centro Oncologico Riojano Integral
  • Royal North Shore Hospital
  • Royal Brisbane and Women s Hospital
  • Peter MacCallum Cancer Centre
  • St John of God
  • Hospital Araujo Jorge
  • Instituto Nacional do Cancer II
  • Hospital de Clinicas de Porto Alegre
  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs
  • Fundacao Dr Amaral Carvalho
  • Instituto do Cancer de Sao Paulo - ICESP
  • Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda
  • Faculdade de Medicina da Universidade Federal de Minas Gerais
  • Tom Baker Cancer Centre
  • Cancer Care Manitoba
  • London Health Sciences Centre
  • Ottawa General Hospital
  • Sunnybrook Health Science Centre
  • Princess Margaret Cancer Centre
  • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont
  • Centre Hospitalier de l Universite de Montreal - CHUM
  • Jewish General Hospital
  • CIUSSS de l'Estrie-CHUS
  • CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
  • Clinica del Country
  • Fundacion Valle del Lili
  • Biomelab S A S
  • Clinica Colsanitas S.A. - Sede Clinica Universitaria Colombia
  • Rodrigo Botero SAS
  • Fundacion Colombiana de Cancerologia Clinica Vida
  • Oncomedica S.A.
  • Institut Bergonie
  • Centre de Lutte Contre le Cancer Francois Baclesse
  • Centre Oscar Lambret
  • Centre Leon Berard
  • Institut Regional du Cancer de Montpellier - ICM
  • Hopital prive du Confluent
  • Groupe Hospitalier Broca Cochin Hotel Dieu
  • Hopital Diaconesses Croix Saint Simon
  • Centre Hospitalier Lyon Sud
  • Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie
  • Centre Eugene Marquis
  • Institut Gustave Roussy
  • EISAI Trial Site 4
  • EISAI Trial Site 2
  • EISAI Trial Site 1
  • EISAI Trial Site 6
  • EISAI Trial Site 3
  • EISAI Trial Site 5
  • Mater Misericordiae University Hospital
  • Soroka Medical Center
  • Rambam Medical Center
  • Edith Wolfson Medical Center
  • Hadassah Medical Center. Ein Kerem
  • Rabin Medical Center
  • Chaim Sheba Medical Center
  • Azienda Ospedaliera per l Emergenza Cannizzaro
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Ospedale San Raffaele
  • Istituto Europeo di Oncologia
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale
  • Policlinico Universitario Agostino Gemelli
  • EISAI Trial Site 9
  • EISAI Trial Site 18
  • EISAI Trial Site 7
  • EISAI Trial Site 15
  • EISAI Trial Site 5
  • EISAI Trial Site 11
  • EISAI Trial Site 8
  • EISAI Trial Site 17
  • EISAI Trial Site 4
  • EISAI Trial Site 19
  • EISAI Trial Site 14
  • EISAI Trial Site 1
  • EISAI Trial Site 2
  • EISAI Trial Site 16
  • EISAI Trial Site 3
  • EISAI Trial Site 10
  • EISAI Trial Site 12
  • EISAI Trial Site 13
  • EISAI Trial Site 6
  • National Cancer Center
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Investigacion Onco Farmaceutica S de RL de CV
  • Alivia Clinica de Alta Especialidad S.A. de C.V.
  • Grupo Medico Camino SC
  • Centro Hemato Oncologico Privado
  • Faicic S de RL de CV
  • Auckland City Hospital
  • Centrum Onkologii Instytut im. Marii Sklodowskiej Curie
  • Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie
  • Beskidzkie Centrum Onkologii im. Jana Pawla II
  • Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o.
  • Centrum Onkologii Instytut im. Marii Sklodowskiej Curie
  • Instytut Centrum Zdrowia Matki Polki
  • Pomorski Uniwersytet Medyczny w Szczecinie
  • Szpital Kliniczny im Ks Anny Mazowieckiej
  • Altay Regional Oncology Dispensary
  • Republican Clinical Oncology Dispensary of Tatarstan MoH
  • FSBI National Medical Oncology Research Center n.a. N.N. Blokhina
  • FSBI-FRCC of Special Types Med. Care & Technologies FMBA of Russia
  • SPb SBHI City Clinical Oncological Dispensary
  • Leningrad Regional Oncology Center
  • Mordovia Republican Oncological Dispensary
  • Tomsk National Research Medical Center of Russian Academy of Sciences
  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan
  • Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals
  • Hospital General Universitari Vall d Hebron
  • Hospital Universitario Gregorio Maranon
  • Clinica Universitaria Navarra - Madrid
  • Hospital Ramon y Cajal
  • Hospital Clinico San Carlos
  • Hospital Universitario y Politecnico La Fe de Valencia
  • Taipei Veterans General Hospital
  • Kaohsiung Veterans General Hospital
  • Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F.
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital
  • Chang Gung Medical Foundation. Linkou Branch
  • Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi
  • Hacettepe University Medical Faculty
  • Baskent Universitesi Ankara Hastanesi
  • Acibadem Bursa Hastanesi
  • Acibadem Universitesi Atakent Hastanesi
  • Florence Nightingale Gayrettepe Hastanesi
  • Ege Universitesi Tip Fakultesi
  • Royal Sussex County Hospital
  • Addenbrookes Hospital
  • Barts Health NHS Trust - St Bartholomew s Hospital
  • Guy s & St Thomas NHS Foundation Trust
  • The Royal Marsden Foundation Trust
  • The Royal Marsden NHS Foundation Trust
  • Imperial College Healthcare NHS Trust
  • University College Hospital
  • University Hospital Southampton NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lenvatinib 20 mg + Pembrolizumab 200 mg

Treatment of Physician's Choice

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression, as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter [mm]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.
Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of death due to any cause. Participants who were lost to follow-up and those who were alive at the date of data cut-off were censored at the date the participant was last known alive, or date of data cut-off, whichever occurred first.

Secondary Outcome Measures

Objective Response Rate (ORR)
ORR was defined as the percentage of participants who had best overall response of either complete response (CR) or partial response (PR) as determined by BICR per RECIST 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (<) 10mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Health-Related Quality of Life (HRQoL) Assessed by European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQC30) Score
EORTC QLQ-C30 was a questionnaire which included 30 questions that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores are transformed to a range of 0 to 100 using a standard EORTC algorithm. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem. Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2023).
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Immune-Related Adverse Events (irAEs)
TEAEs was defined as AEs that occurred (or worsened, if present at Baseline) after the first dose of study drug through 28 days after the last dose of study drug. AE was defined as any untoward medical occurrence in a participants or clinical study participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. A SAE was defined as any untoward medical occurrence at any dose if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect. irAE was 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.
Percentage of Participants Discontinued Study Treatment Due to TEAEs
TEAEs was defined as those AEs that occurred (or worsened, if present at Baseline) after the first dose of study drug through 30 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical study participant temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time to Treatment Failure Due to Toxicity
Time to treatment failure due to toxicity was defined as the time from the date of randomization to the date a participant discontinued study treatment due to TEAEs. Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2023).
Model Predicted Apparent Total Clearance (CL/F) for Lenvatinib
Sparse pharmacokinetic (PK) samples were collected and analyzed using a population PK approach to estimate PK parameters. Individual predicted CL/F for lenvatinib was then derived from the PK model. The data was collected and analyzed for lenvatinib plus pembrolizumab arm only.
Model Predicted Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib
Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. Individual predicted AUC for lenvatinib was then derived from the PK model. The data was collected and analyzed for lenvatinib plus pembrolizumab arm only.

Full Information

First Posted
April 25, 2018
Last Updated
October 17, 2023
Sponsor
Eisai Inc.
Collaborators
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT03517449
Brief Title
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])
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
October 26, 2020 (Actual)
Study Completion Date
October 7, 2024 (Anticipated)

3. Sponsor/Collaborators

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

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
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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lenvatinib 20 mg + Pembrolizumab 200 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment of Physician's Choice
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
KEYTRUDA®, MK-3475
Intervention Description
200 mg administered by IV infusion on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
LENVIMA®
Intervention Description
20 mg administered orally (PO) QD during each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
TAXOL®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
ADRIAMYCIN®
Intervention Description
60 mg/m^2 administered by IV on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression, as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter [mm]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.
Time Frame
From the date of randomization to the date of the first documentation of disease progression or death, whichever occurred first or up to data cutoff date 26 October 2020 (up to approximately 2 years 5 months)
Title
Overall Survival (OS)
Description
OS was defined as the time from the date of randomization to the date of death due to any cause. Participants who were lost to follow-up and those who were alive at the date of data cut-off were censored at the date the participant was last known alive, or date of data cut-off, whichever occurred first.
Time Frame
From the date of randomization until the date of death from any cause or up to data cutoff date 26 October 2020 (up to approximately 2 years 5 months)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR was defined as the percentage of participants who had best overall response of either complete response (CR) or partial response (PR) as determined by BICR per RECIST 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (<) 10mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame
From date of randomization up to first documentation of PD or date of death, whichever occurred first up to data cutoff date 26 October 2020 (up to approximately 2 years 5 months)
Title
Health-Related Quality of Life (HRQoL) Assessed by European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQC30) Score
Description
EORTC QLQ-C30 was a questionnaire which included 30 questions that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores are transformed to a range of 0 to 100 using a standard EORTC algorithm. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem. Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2023).
Time Frame
At baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle (cycle length of either 21 or 28 days), and at the post-treatment visit (up to 5 years and 5 months)
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Immune-Related Adverse Events (irAEs)
Description
TEAEs was defined as AEs that occurred (or worsened, if present at Baseline) after the first dose of study drug through 28 days after the last dose of study drug. AE was defined as any untoward medical occurrence in a participants or clinical study participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. A SAE was defined as any untoward medical occurrence at any dose if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect. irAE was 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.
Time Frame
From the first dose of study drug up to data cutoff date 26 October 2020 (up to approximately 2 years 5 months)
Title
Percentage of Participants Discontinued Study Treatment Due to TEAEs
Description
TEAEs was defined as those AEs that occurred (or worsened, if present at Baseline) after the first dose of study drug through 30 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical study participant temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time Frame
From the first dose of study drug up to data cutoff date 26 October 2020 (up to approximately 2 years 5 months)
Title
Time to Treatment Failure Due to Toxicity
Description
Time to treatment failure due to toxicity was defined as the time from the date of randomization to the date a participant discontinued study treatment due to TEAEs. Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2023).
Time Frame
From the date of randomization to the date of discontinuation of study treatment due to TEAEs (up to 5 years 5 months)
Title
Model Predicted Apparent Total Clearance (CL/F) for Lenvatinib
Description
Sparse pharmacokinetic (PK) samples were collected and analyzed using a population PK approach to estimate PK parameters. Individual predicted CL/F for lenvatinib was then derived from the PK model. The data was collected and analyzed for lenvatinib plus pembrolizumab arm only.
Time Frame
Cycle 1 Day 1: 0.5-10 hours post-dose; Cycle 1 Day 15: 0-12 hours post-dose; Cycle 2 Day 1: 0.5-10 hours post-dose (each cycle length=21 days)
Title
Model Predicted Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib
Description
Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. Individual predicted AUC for lenvatinib was then derived from the PK model. The data was collected and analyzed for lenvatinib plus pembrolizumab arm only.
Time Frame
Cycle 1 Day 1: 0.5-10 hours post-dose; Cycle 1 Day 15: 0-12 hours post-dose; Cycle 2 Day 1: 0.5-10 hours post-dose (each cycle length=21 days)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a histologically confirmed diagnosis of endometrial carcinoma (EC) Documented evidence of advanced, recurrent or metastatic EC. 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. Has historical or fresh tumor biopsy specimen for determination of mismatch repair (MMR) status. 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. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment. 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: Has carcinosarcoma (malignant mixed mullerian tumor), endometrial leiomyosarcoma and endometrial stromal sarcomas. Has unstable central nervous system (CNS) metastases. 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. Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib. Has a pre-existing greater than or equal (>=) Grade 3 gastrointestinal or non-gastrointestinal fistula. Has radiographic evidence of major blood vessel invasion/infiltration. Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment. 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. Has an active infection requiring systemic treatment. Has not recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy. Is positive for Human Immunodeficiency Virus (HIV). Has active Hepatitis B or C. Has a history of (non-infectious) pneumonitis that required treatment with steroids, or has current pneumonitis. Has known psychiatric or substance abuse disorders 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 study start -Has an active autoimmune disease (with the exception of psoriasis) that has required systemic treatment in the past 2 years. Is pregnant or breastfeeding. Has had an allogenic tissue/solid organ transplant. 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. 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. Has received prior treatment with any treatment targeting VEGF-directed angiogenesis, any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. 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. 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. Has received a live vaccine within 30 days of study start. Has a known intolerance to study treatment (or any of the excipients). Prior enrollment on a clinical study evaluating pembrolizumab and lenvatinib for endometrial carcinoma, regardless of treatment received. 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. Participants with urine protein ≥1 gram (g)/24 hour. Prolongation of corrected QT (QTc) interval to >480 milliseconds (ms). Left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Eisai Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates, PC- HAL
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
University of California Los Angeles
City
Santa Monica
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Smilow Cancer Hospital at Yale New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
University of Miami Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Georgia Cancer Center at Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
North Shore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
University Medical Center New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Maryland Oncology Hematology, P.A.
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Med Ctr
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Willamette Valley Cancer Institute and Research Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Sanford Gynecology Oncology
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
UT West Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Texas Oncology-South Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9032
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology-San Antonio Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Centro de Oncologia e Investigacion Buenos Aires COIBA
City
Berazategui
State/Province
Buenos Aires
ZIP/Postal Code
B1884BBF
Country
Argentina
Facility Name
Hospital Privado de la Comunidad
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7602CBM
Country
Argentina
Facility Name
Instituto de Investigaciones Metabolicas
City
Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Hospital Aleman
City
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Instituto de Oncologia Angel H. Roffo
City
Buenos Aires
ZIP/Postal Code
C1417DTB
Country
Argentina
Facility Name
Instituto Medico Especializado Alexander Fleming
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Centro Oncologico Riojano Integral
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Facility Name
Royal North Shore Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Royal Brisbane and Women s Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
St John of God
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Hospital Araujo Jorge
City
Goiania
State/Province
GO
ZIP/Postal Code
74175-120
Country
Brazil
Facility Name
Instituto Nacional do Cancer II
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20220-410
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Fundacao Dr Amaral Carvalho
City
Jau
State/Province
SP
ZIP/Postal Code
17210-080
Country
Brazil
Facility Name
Instituto do Cancer de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317-000
Country
Brazil
Facility Name
Faculdade de Medicina da Universidade Federal de Minas Gerais
City
Belo Horizonte
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cancer Care Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Ottawa General Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Cancer Centre
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
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Centre Hospitalier de l Universite de Montreal - CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
CIUSSS de l'Estrie-CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Clinica del Country
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Fundacion Valle del Lili
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Biomelab S A S
City
Barranquilla
ZIP/Postal Code
08002
Country
Colombia
Facility Name
Clinica Colsanitas S.A. - Sede Clinica Universitaria Colombia
City
Bogota
ZIP/Postal Code
111321
Country
Colombia
Facility Name
Rodrigo Botero SAS
City
Medellin
ZIP/Postal Code
50015
Country
Colombia
Facility Name
Fundacion Colombiana de Cancerologia Clinica Vida
City
Medellin
ZIP/Postal Code
50032
Country
Colombia
Facility Name
Oncomedica S.A.
City
Monteria
ZIP/Postal Code
230002
Country
Colombia
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre de Lutte Contre le Cancer Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institut Regional du Cancer de Montpellier - ICM
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital prive du Confluent
City
Nantes
ZIP/Postal Code
44277
Country
France
Facility Name
Groupe Hospitalier Broca Cochin Hotel Dieu
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Diaconesses Croix Saint Simon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie
City
Plerin
ZIP/Postal Code
22190
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
EISAI Trial Site 4
City
Berlin
Country
Germany
Facility Name
EISAI Trial Site 2
City
Dresden
Country
Germany
Facility Name
EISAI Trial Site 1
City
Erlangen
Country
Germany
Facility Name
EISAI Trial Site 6
City
Hamburg
Country
Germany
Facility Name
EISAI Trial Site 3
City
Rostock
Country
Germany
Facility Name
EISAI Trial Site 5
City
Tuebingen
Country
Germany
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
D07 R2WY
Country
Ireland
Facility Name
Soroka Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3525408
Country
Israel
Facility Name
Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Hadassah Medical Center. Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Azienda Ospedaliera per l Emergenza Cannizzaro
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
168
Country
Italy
Facility Name
EISAI Trial Site 9
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
EISAI Trial Site 18
City
Kashiwa
State/Province
Chiba
Country
Japan
Facility Name
EISAI Trial Site 7
City
Matsuyama
State/Province
Ehime
Country
Japan
Facility Name
EISAI Trial Site 15
City
Toon
State/Province
Ehime
Country
Japan
Facility Name
EISAI Trial Site 5
City
Kurume
State/Province
Fukoka
Country
Japan
Facility Name
EISAI Trial Site 11
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
EISAI Trial Site 8
City
Akashi
State/Province
Hyogo
Country
Japan
Facility Name
EISAI Trial Site 17
City
Tsukuba
State/Province
Ibaraki
Country
Japan
Facility Name
EISAI Trial Site 4
City
Morioka
State/Province
Iwate
Country
Japan
Facility Name
EISAI Trial Site 19
City
Isehara
State/Province
Kanagawa
Country
Japan
Facility Name
EISAI Trial Site 14
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
EISAI Trial Site 1
City
Hidaka
State/Province
Saitama
Country
Japan
Facility Name
EISAI Trial Site 2
City
Sunto-gun
State/Province
Shizuoka
Country
Japan
Facility Name
EISAI Trial Site 16
City
Kagoshima
Country
Japan
Facility Name
EISAI Trial Site 3
City
Niigata
Country
Japan
Facility Name
EISAI Trial Site 10
City
Tokyo
Country
Japan
Facility Name
EISAI Trial Site 12
City
Tokyo
Country
Japan
Facility Name
EISAI Trial Site 13
City
Tokyo
Country
Japan
Facility Name
EISAI Trial Site 6
City
Tokyo
Country
Japan
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Facility Name
Investigacion Onco Farmaceutica S de RL de CV
City
La Paz
State/Province
Baja California
ZIP/Postal Code
23040
Country
Mexico
Facility Name
Alivia Clinica de Alta Especialidad S.A. de C.V.
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Grupo Medico Camino SC
City
Mexico City
ZIP/Postal Code
3310
Country
Mexico
Facility Name
Centro Hemato Oncologico Privado
City
Toluca
ZIP/Postal Code
50080
Country
Mexico
Facility Name
Faicic S de RL de CV
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Centrum Onkologii Instytut im. Marii Sklodowskiej Curie
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Beskidzkie Centrum Onkologii im. Jana Pawla II
City
Bielsko-Biala
ZIP/Postal Code
43-300
Country
Poland
Facility Name
Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o.
City
Gdynia
ZIP/Postal Code
81-159
Country
Poland
Facility Name
Centrum Onkologii Instytut im. Marii Sklodowskiej Curie
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Instytut Centrum Zdrowia Matki Polki
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Pomorski Uniwersytet Medyczny w Szczecinie
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Szpital Kliniczny im Ks Anny Mazowieckiej
City
Warszawa
ZIP/Postal Code
00-315
Country
Poland
Facility Name
Altay Regional Oncology Dispensary
City
Barnaul
ZIP/Postal Code
656049
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Tatarstan MoH
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
FSBI National Medical Oncology Research Center n.a. N.N. Blokhina
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
FSBI-FRCC of Special Types Med. Care & Technologies FMBA of Russia
City
Moscow
ZIP/Postal Code
115682
Country
Russian Federation
Facility Name
SPb SBHI City Clinical Oncological Dispensary
City
Saint Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Leningrad Regional Oncology Center
City
Saint-Petersburg
ZIP/Postal Code
191014
Country
Russian Federation
Facility Name
Mordovia Republican Oncological Dispensary
City
Saransk
ZIP/Postal Code
430032
Country
Russian Federation
Facility Name
Tomsk National Research Medical Center of Russian Academy of Sciences
City
Tomsk
ZIP/Postal Code
624028
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Republic of Bashkortostan
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
8908
Country
Spain
Facility Name
Hospital General Universitari Vall d Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Clinica Universitaria Navarra - Madrid
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Taipei Veterans General Hospital
City
Taipei
State/Province
Beitou
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F.
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Chang Gung Medical Foundation. Linkou Branch
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06000
Country
Turkey
Facility Name
Baskent Universitesi Ankara Hastanesi
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Facility Name
Acibadem Bursa Hastanesi
City
Bursa
ZIP/Postal Code
16110
Country
Turkey
Facility Name
Acibadem Universitesi Atakent Hastanesi
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Facility Name
Florence Nightingale Gayrettepe Hastanesi
City
Istanbul
ZIP/Postal Code
34349
Country
Turkey
Facility Name
Ege Universitesi Tip Fakultesi
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Barts Health NHS Trust - St Bartholomew s Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Guy s & St Thomas NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
The Royal Marsden Foundation Trust
City
London
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
University College Hospital
City
London
ZIP/Postal Code
WC1E 6AG
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35045221
Citation
Makker V, Colombo N, Casado Herraez A, Santin AD, Colomba E, Miller DS, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Sakata J, Yonemori K, Kim YM, Guerra EM, Sanli UA, McCormack MM, Smith AD, Keefe S, Bird S, Dutta L, Orlowski RJ, Lorusso D; Study 309-KEYNOTE-775 Investigators. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer. N Engl J Med. 2022 Feb 3;386(5):437-448. doi: 10.1056/NEJMoa2108330. Epub 2022 Jan 19.
Results Reference
derived

Learn more about this trial

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])

We'll reach out to this number within 24 hrs