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])
NCT ID: NCT03517449
Last Updated: 2025-06-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
827 participants
INTERVENTIONAL
2018-06-11
2025-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Pembrolizumab
200 mg administered by IV infusion on Day 1 of each 21-day cycle.
Lenvatinib
20 mg administered orally (PO) QD during each 21-day cycle.
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.
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.
Doxorubicin
60 mg/m\^2 administered by IV on Day 1 of each 21-day cycle.
Interventions
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Pembrolizumab
200 mg administered by IV infusion on Day 1 of each 21-day cycle.
Lenvatinib
20 mg administered orally (PO) QD during each 21-day cycle.
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.
Doxorubicin
60 mg/m\^2 administered by IV on Day 1 of each 21-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
FEMALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Eisai Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Eisai Inc.
Locations
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Arizona Oncology Associates, PC- HAL
Phoenix, Arizona, United States
University of California San Francisco
San Francisco, California, United States
University of California Los Angeles
Santa Monica, California, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States
University of Miami Health System
Miami, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
North Shore University Health System
Evanston, Illinois, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Maryland Oncology Hematology, P.A.
Wheaton, Maryland, United States
John Theurer Cancer Center at Hackensack University Med Ctr
Hackensack, New Jersey, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Sanford Gynecology Oncology
Sioux Falls, South Dakota, United States
UT West Cancer Center
Germantown, Tennessee, United States
Texas Oncology-South Austin
Austin, Texas, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology-San Antonio Medical Center
San Antonio, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Centro de Oncologia e Investigacion Buenos Aires COIBA
Berazategui, Buenos Aires, Argentina
Hospital Privado de la Comunidad
Mar del Plata, Buenos Aires, Argentina
Instituto de Investigaciones Metabolicas
Buenos Aires, , Argentina
Hospital Aleman
Buenos Aires, , Argentina
Instituto de Oncologia Angel H. Roffo
Buenos Aires, , Argentina
Instituto Medico Especializado Alexander Fleming
Buenos Aires, , Argentina
Centro Oncologico Riojano Integral
La Rioja, , Argentina
Royal North Shore Hospital
Sydney, New South Wales, Australia
Royal Brisbane and Women s Hospital
Herston, Queensland, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
St John of God
Subiaco, Western Australia, Australia
Hospital Araujo Jorge
Goiânia, Goiás, Brazil
Instituto Nacional do Cancer II
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Dr Amaral Carvalho
Jaú, São Paulo, Brazil
Instituto do Cancer de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda
São Paulo, São Paulo, Brazil
Faculdade de Medicina da Universidade Federal de Minas Gerais
Belo Horizonte, , Brazil
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa General Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Centre Hospitalier de l Universite de Montreal - CHUM
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, Canada
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec
Québec, , Canada
Clinica del Country
Bogota, Cundinamarca, Colombia
Fundacion Valle del Lili
Cali, Valle del Cauca Department, Colombia
Biomelab S A S
Barranquilla, , Colombia
Clinica Colsanitas S.A. - Sede Clinica Universitaria Colombia
Bogotá, , Colombia
Rodrigo Botero SAS
Medellín, , Colombia
Fundacion Colombiana de Cancerologia Clinica Vida
Medellín, , Colombia
Oncomedica S.A.
Montería, , Colombia
Institut Bergonie
Bordeaux, , France
Centre de Lutte Contre le Cancer Francois Baclesse
Caen, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Institut Regional du Cancer de Montpellier - ICM
Montpellier, , France
Hopital prive du Confluent
Nantes, , France
Groupe Hospitalier Broca Cochin Hotel Dieu
Paris, , France
Hopital Diaconesses Croix Saint Simon
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie
Plérin, , France
Centre Eugene Marquis
Rennes, , France
Institut Gustave Roussy
Villejuif, , France
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
Tübingen, , Germany
Mater Misericordiae University Hospital
Dublin, , Ireland
Soroka Medical Center
Beersheba, , Israel
Rambam Medical Center
Haifa, , Israel
Edith Wolfson Medical Center
Holon, , Israel
Hadassah Medical Center. Ein Kerem
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Azienda Ospedaliera per l Emergenza Cannizzaro
Catania, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli, , Italy
Policlinico Universitario Agostino Gemelli
Roma, , Italy
EISAI Trial Site 9
Nagoya, Aichi-ken, Japan
EISAI Trial Site 18
Kashiwa, Chiba, Japan
EISAI Trial Site 7
Matsuyama, Ehime, Japan
EISAI Trial Site 15
Tōon, Ehime, Japan
EISAI Trial Site 5
Kurume, Fukoka, Japan
EISAI Trial Site 11
Sapporo, Hokkaido, Japan
EISAI Trial Site 8
Akashi, Hyōgo, Japan
EISAI Trial Site 17
Tsukuba, Ibaraki, Japan
EISAI Trial Site 4
Morioka, Iwate, Japan
EISAI Trial Site 19
Isehara, Kanagawa, Japan
EISAI Trial Site 14
Sendai, Miyagi, Japan
EISAI Trial Site 1
Hidaka, Saitama, Japan
EISAI Trial Site 2
Sunto-gun, Shizuoka, 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
Investigacion Onco Farmaceutica S de RL de CV
La Paz, Estado de Baja California, Mexico
Alivia Clinica de Alta Especialidad S.A. de C.V.
Monterrey, Nuevo León, Mexico
Grupo Medico Camino SC
Mexico City, , Mexico
Centro Hemato Oncologico Privado
Toluca, , Mexico
Faicic S de RL de CV
Veracruz, , Mexico
Auckland City Hospital
Auckland, , New Zealand
Centrum Onkologii Instytut im. Marii Sklodowskiej Curie
Krakow, Lesser Poland Voivodeship, Poland
Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie
Warsaw, Masovian Voivodeship, Poland
Beskidzkie Centrum Onkologii im. Jana Pawla II
Bielsko-Biala, , Poland
Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o.
Gdynia, , Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej Curie
Gliwice, , Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, , Poland
Pomorski Uniwersytet Medyczny w Szczecinie
Szczecin, , Poland
Szpital Kliniczny im Ks Anny Mazowieckiej
Warsaw, , Poland
Altay Regional Oncology Dispensary
Barnaul, , Russia
Republican Clinical Oncology Dispensary of Tatarstan MoH
Kazan', , Russia
FSBI National Medical Oncology Research Center n.a. N.N. Blokhina
Moscow, , Russia
FSBI-FRCC of Special Types Med. Care & Technologies FMBA of Russia
Moscow, , Russia
Leningrad Regional Oncology Center
Saint Petersburg, , Russia
SPb SBHI City Clinical Oncological Dispensary
Saint Petersburg, , Russia
Mordovia Republican Oncological Dispensary
Saransk, , Russia
Tomsk National Research Medical Center of Russian Academy of Sciences
Tomsk, , Russia
Republican Clinical Oncology Dispensary of Republic of Bashkortostan
Ufa, , Russia
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General Universitari Vall d Hebron
Barcelona, , Spain
Hospital Universitario Gregorio Maranon
Madrid, , Spain
Clinica Universitaria Navarra - Madrid
Madrid, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario y Politecnico La Fe de Valencia
Valencia, , Spain
Taipei Veterans General Hospital
Taipei, Beitou, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F.
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation. Linkou Branch
Taoyuan District, , Taiwan
Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi
Adana, , Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Baskent Universitesi Ankara Hastanesi
Ankara, , Turkey (Türkiye)
Acibadem Bursa Hastanesi
Bursa, , Turkey (Türkiye)
Acibadem Universitesi Atakent Hastanesi
Istanbul, , Turkey (Türkiye)
Florence Nightingale Gayrettepe Hastanesi
Istanbul, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi
Izmir, , Turkey (Türkiye)
Royal Sussex County Hospital
Brighton, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Barts Health NHS Trust - St Bartholomew s Hospital
London, , United Kingdom
Guy s & St Thomas NHS Foundation Trust
London, , United Kingdom
The Royal Marsden Foundation Trust
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
University College Hospital
London, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Countries
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References
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Yonemori K, Fujiwara K, Hasegawa K, Yunokawa M, Ushijima K, Suzuki S, Shikama A, Minobe S, Usami T, Kim JW, Kim BG, Wang PH, Chang TC, Yamamoto K, Han S, McKenzie J, Orlowski RJ, Miura T, Makker V, Man Kim Y. Analysis of East Asia subgroup in Study 309/KEYNOTE-775: lenvatinib plus pembrolizumab versus treatment of physician's choice chemotherapy in patients with previously treated advanced or recurrent endometrial cancer. J Gynecol Oncol. 2024 Mar;35(2):e40. doi: 10.3802/jgo.2024.35.e40. Epub 2024 Jan 19.
Colombo N, Lorusso D, Monk BJ, Slomovitz B, Hasegawa K, Nogueira-Rodrigues A, Zale M, Okpara CE, Barresi G, McKenzie J, Makker V. Characterization and Management of Adverse Reactions in Patients With Advanced Endometrial Cancer Receiving Lenvatinib Plus Pembrolizumab. Oncologist. 2024 Jan 5;29(1):25-35. doi: 10.1093/oncolo/oyad201.
Lorusso D, Colombo N, Herraez AC, Santin AD, Colomba E, Miller DS, Fujiwara K, Pignata S, Baron-Hay SE, Ray-Coquard IL, Shapira-Frommer R, Kim YM, McCormack M, Massaad R, Nguyen AM, Zhao Q, McKenzie J, Prabhu VS, Makker V. Health-Related Quality of Life in Patients With Advanced Endometrial Cancer Treated With Lenvatinib Plus Pembrolizumab or Treatment of Physician's Choice. Eur J Cancer. 2023 Jun;186:172-184. doi: 10.1016/j.ejca.2023.03.015. Epub 2023 Mar 23.
Makker V, Colombo N, Casado Herraez A, Monk BJ, Mackay H, Santin AD, Miller DS, Moore RG, Baron-Hay S, Ray-Coquard I, Ushijima K, Yonemori K, Kim YM, Guerra Alia EM, Sanli UA, Bird S, Orlowski R, McKenzie J, Okpara C, Barresi G, Lorusso D. Lenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775. J Clin Oncol. 2023 Jun 1;41(16):2904-2910. doi: 10.1200/JCO.22.02152. Epub 2023 Apr 14.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-004387-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MK3475-775
Identifier Type: OTHER
Identifier Source: secondary_id
E7080-G000-309
Identifier Type: -
Identifier Source: org_study_id
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