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

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

827 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-11

Study Completion Date

2025-02-26

Brief Summary

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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.

Detailed Description

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Conditions

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Endometrial Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type DRUG

200 mg administered by IV infusion on Day 1 of each 21-day cycle.

Lenvatinib

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Paclitaxel

Intervention Type DRUG

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

Intervention Type DRUG

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.

Intervention Type DRUG

Lenvatinib

20 mg administered orally (PO) QD during each 21-day cycle.

Intervention Type 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.

Intervention Type DRUG

Doxorubicin

60 mg/m\^2 administered by IV on Day 1 of each 21-day cycle.

Intervention Type DRUG

Other Intervention Names

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KEYTRUDA® MK-3475 LENVIMA® TAXOL® ADRIAMYCIN®

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Eisai Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

University of California San Francisco

San Francisco, California, United States

Site Status

University of California Los Angeles

Santa Monica, California, United States

Site Status

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, United States

Site Status

University of Miami Health System

Miami, Florida, United States

Site Status

Florida Hospital Cancer Institute

Orlando, Florida, United States

Site Status

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States

Site Status

North Shore University Health System

Evanston, Illinois, United States

Site Status

University Medical Center New Orleans

New Orleans, Louisiana, United States

Site Status

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Site Status

Maryland Oncology Hematology, P.A.

Wheaton, Maryland, United States

Site Status

John Theurer Cancer Center at Hackensack University Med Ctr

Hackensack, New Jersey, United States

Site Status

Holy Name Medical Center

Teaneck, New Jersey, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States

Site Status

Sanford Gynecology Oncology

Sioux Falls, South Dakota, United States

Site Status

UT West Cancer Center

Germantown, Tennessee, United States

Site Status

Texas Oncology-South Austin

Austin, Texas, United States

Site Status

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Texas Oncology-San Antonio Medical Center

San Antonio, Texas, United States

Site Status

Utah Cancer Specialists

Salt Lake City, Utah, United States

Site Status

Centro de Oncologia e Investigacion Buenos Aires COIBA

Berazategui, Buenos Aires, Argentina

Site Status

Hospital Privado de la Comunidad

Mar del Plata, Buenos Aires, Argentina

Site Status

Instituto de Investigaciones Metabolicas

Buenos Aires, , Argentina

Site Status

Hospital Aleman

Buenos Aires, , Argentina

Site Status

Instituto de Oncologia Angel H. Roffo

Buenos Aires, , Argentina

Site Status

Instituto Medico Especializado Alexander Fleming

Buenos Aires, , Argentina

Site Status

Centro Oncologico Riojano Integral

La Rioja, , Argentina

Site Status

Royal North Shore Hospital

Sydney, New South Wales, Australia

Site Status

Royal Brisbane and Women s Hospital

Herston, Queensland, Australia

Site Status

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status

St John of God

Subiaco, Western Australia, Australia

Site Status

Hospital Araujo Jorge

Goiânia, Goiás, Brazil

Site Status

Instituto Nacional do Cancer II

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Fundacao Dr Amaral Carvalho

Jaú, São Paulo, Brazil

Site Status

Instituto do Cancer de Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

Site Status

Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda

São Paulo, São Paulo, Brazil

Site Status

Faculdade de Medicina da Universidade Federal de Minas Gerais

Belo Horizonte, , Brazil

Site Status

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Site Status

London Health Sciences Centre

London, Ontario, Canada

Site Status

Ottawa General Hospital

Ottawa, Ontario, Canada

Site Status

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

Site Status

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status

Centre Hospitalier de l Universite de Montreal - CHUM

Montreal, Quebec, Canada

Site Status

Jewish General Hospital

Montreal, Quebec, Canada

Site Status

CIUSSS de l'Estrie-CHUS

Sherbrooke, Quebec, Canada

Site Status

CHU de Quebec-Universite Laval-Hotel Dieu de Quebec

Québec, , Canada

Site Status

Clinica del Country

Bogota, Cundinamarca, Colombia

Site Status

Fundacion Valle del Lili

Cali, Valle del Cauca Department, Colombia

Site Status

Biomelab S A S

Barranquilla, , Colombia

Site Status

Clinica Colsanitas S.A. - Sede Clinica Universitaria Colombia

Bogotá, , Colombia

Site Status

Rodrigo Botero SAS

Medellín, , Colombia

Site Status

Fundacion Colombiana de Cancerologia Clinica Vida

Medellín, , Colombia

Site Status

Oncomedica S.A.

Montería, , Colombia

Site Status

Institut Bergonie

Bordeaux, , France

Site Status

Centre de Lutte Contre le Cancer Francois Baclesse

Caen, , France

Site Status

Centre Oscar Lambret

Lille, , France

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Centre Leon Berard

Lyon, , France

Site Status

Institut Regional du Cancer de Montpellier - ICM

Montpellier, , France

Site Status

Hopital prive du Confluent

Nantes, , France

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Groupe Hospitalier Broca Cochin Hotel Dieu

Paris, , France

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Hopital Diaconesses Croix Saint Simon

Paris, , France

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Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

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Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie

Plérin, , France

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Centre Eugene Marquis

Rennes, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

EISAI Trial Site 4

Berlin, , Germany

Site Status

EISAI Trial Site 2

Dresden, , Germany

Site Status

EISAI Trial Site 1

Erlangen, , Germany

Site Status

EISAI Trial Site 6

Hamburg, , Germany

Site Status

EISAI Trial Site 3

Rostock, , Germany

Site Status

EISAI Trial Site 5

Tübingen, , Germany

Site Status

Mater Misericordiae University Hospital

Dublin, , Ireland

Site Status

Soroka Medical Center

Beersheba, , Israel

Site Status

Rambam Medical Center

Haifa, , Israel

Site Status

Edith Wolfson Medical Center

Holon, , Israel

Site Status

Hadassah Medical Center. Ein Kerem

Jerusalem, , Israel

Site Status

Rabin Medical Center

Petah Tikva, , Israel

Site Status

Chaim Sheba Medical Center

Ramat Gan, , Israel

Site Status

Azienda Ospedaliera per l Emergenza Cannizzaro

Catania, , Italy

Site Status

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, , Italy

Site Status

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

Site Status

Ospedale San Raffaele

Milan, , Italy

Site Status

Istituto Europeo di Oncologia

Milan, , Italy

Site Status

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Napoli, , Italy

Site Status

Policlinico Universitario Agostino Gemelli

Roma, , Italy

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EISAI Trial Site 9

Nagoya, Aichi-ken, Japan

Site Status

EISAI Trial Site 18

Kashiwa, Chiba, Japan

Site Status

EISAI Trial Site 7

Matsuyama, Ehime, Japan

Site Status

EISAI Trial Site 15

Tōon, Ehime, Japan

Site Status

EISAI Trial Site 5

Kurume, Fukoka, Japan

Site Status

EISAI Trial Site 11

Sapporo, Hokkaido, Japan

Site Status

EISAI Trial Site 8

Akashi, Hyōgo, Japan

Site Status

EISAI Trial Site 17

Tsukuba, Ibaraki, Japan

Site Status

EISAI Trial Site 4

Morioka, Iwate, Japan

Site Status

EISAI Trial Site 19

Isehara, Kanagawa, Japan

Site Status

EISAI Trial Site 14

Sendai, Miyagi, Japan

Site Status

EISAI Trial Site 1

Hidaka, Saitama, Japan

Site Status

EISAI Trial Site 2

Sunto-gun, Shizuoka, Japan

Site Status

EISAI Trial Site 16

Kagoshima, , Japan

Site Status

EISAI Trial Site 3

Niigata, , Japan

Site Status

EISAI Trial Site 10

Tokyo, , Japan

Site Status

EISAI Trial Site 12

Tokyo, , Japan

Site Status

EISAI Trial Site 13

Tokyo, , Japan

Site Status

EISAI Trial Site 6

Tokyo, , Japan

Site Status

Investigacion Onco Farmaceutica S de RL de CV

La Paz, Estado de Baja California, Mexico

Site Status

Alivia Clinica de Alta Especialidad S.A. de C.V.

Monterrey, Nuevo León, Mexico

Site Status

Grupo Medico Camino SC

Mexico City, , Mexico

Site Status

Centro Hemato Oncologico Privado

Toluca, , Mexico

Site Status

Faicic S de RL de CV

Veracruz, , Mexico

Site Status

Auckland City Hospital

Auckland, , New Zealand

Site Status

Centrum Onkologii Instytut im. Marii Sklodowskiej Curie

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie

Warsaw, Masovian Voivodeship, Poland

Site Status

Beskidzkie Centrum Onkologii im. Jana Pawla II

Bielsko-Biala, , Poland

Site Status

Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o.

Gdynia, , Poland

Site Status

Centrum Onkologii Instytut im. Marii Sklodowskiej Curie

Gliwice, , Poland

Site Status

Instytut Centrum Zdrowia Matki Polki

Lodz, , Poland

Site Status

Pomorski Uniwersytet Medyczny w Szczecinie

Szczecin, , Poland

Site Status

Szpital Kliniczny im Ks Anny Mazowieckiej

Warsaw, , Poland

Site Status

Altay Regional Oncology Dispensary

Barnaul, , Russia

Site Status

Republican Clinical Oncology Dispensary of Tatarstan MoH

Kazan', , Russia

Site Status

FSBI National Medical Oncology Research Center n.a. N.N. Blokhina

Moscow, , Russia

Site Status

FSBI-FRCC of Special Types Med. Care & Technologies FMBA of Russia

Moscow, , Russia

Site Status

Leningrad Regional Oncology Center

Saint Petersburg, , Russia

Site Status

SPb SBHI City Clinical Oncological Dispensary

Saint Petersburg, , Russia

Site Status

Mordovia Republican Oncological Dispensary

Saransk, , Russia

Site Status

Tomsk National Research Medical Center of Russian Academy of Sciences

Tomsk, , Russia

Site Status

Republican Clinical Oncology Dispensary of Republic of Bashkortostan

Ufa, , Russia

Site Status

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital General Universitari Vall d Hebron

Barcelona, , Spain

Site Status

Hospital Universitario Gregorio Maranon

Madrid, , Spain

Site Status

Clinica Universitaria Navarra - Madrid

Madrid, , Spain

Site Status

Hospital Ramon y Cajal

Madrid, , Spain

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario y Politecnico La Fe de Valencia

Valencia, , Spain

Site Status

Taipei Veterans General Hospital

Taipei, Beitou, Taiwan

Site Status

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status

Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F.

Kaohsiung City, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Chang Gung Medical Foundation. Linkou Branch

Taoyuan District, , Taiwan

Site Status

Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi

Adana, , Turkey (Türkiye)

Site Status

Hacettepe University Medical Faculty

Ankara, , Turkey (Türkiye)

Site Status

Baskent Universitesi Ankara Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Acibadem Bursa Hastanesi

Bursa, , Turkey (Türkiye)

Site Status

Acibadem Universitesi Atakent Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Florence Nightingale Gayrettepe Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Ege Universitesi Tip Fakultesi

Izmir, , Turkey (Türkiye)

Site Status

Royal Sussex County Hospital

Brighton, , United Kingdom

Site Status

Addenbrookes Hospital

Cambridge, , United Kingdom

Site Status

Barts Health NHS Trust - St Bartholomew s Hospital

London, , United Kingdom

Site Status

Guy s & St Thomas NHS Foundation Trust

London, , United Kingdom

Site Status

The Royal Marsden Foundation Trust

London, , United Kingdom

Site Status

The Royal Marsden NHS Foundation Trust

London, , United Kingdom

Site Status

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

University College Hospital

London, , United Kingdom

Site Status

University Hospital Southampton NHS Foundation Trust

Southampton, , United Kingdom

Site Status

Countries

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United States Argentina Australia Brazil Canada Colombia France Germany Ireland Israel Italy Japan Mexico New Zealand Poland Russia South Korea Spain Taiwan Turkey (Türkiye) United Kingdom

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.

Reference Type DERIVED
PMID: 38302725 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37523661 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37086595 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37058687 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35045221 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

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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