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New combo therapy shows promise for advanced uterine cancer

NCT ID NCT03517449

Disease control Sponsor: Eisai Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a combination of two drugs, lenvatinib and pembrolizumab, against standard chemotherapy in 827 people with advanced endometrial cancer that had worsened after initial treatment. The goal was to see if the combo could delay cancer growth and extend life. Results showed the combination improved how long patients lived without their cancer getting worse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

827 people

The number who actually took part.

Started

Jun 2018

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 endometrial carcinoma endometrium neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometrial neoplasms

Contacts and locations

Locations

  • Acibadem Bursa Hastanesi

    Bursa, 16110, Turkey (Türkiye)

  • Acibadem Universitesi Atakent Hastanesi

    Istanbul, 34303, Turkey (Türkiye)

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ, United Kingdom

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

    Monterrey, Nuevo León, 64060, Mexico

  • Altay Regional Oncology Dispensary

    Barnaul, 656049, Russia

  • Arizona Oncology Associates, PC- HAL

    Phoenix, Arizona, 85016, United States

  • Asan Medical Center

    Seoul, 5505, South Korea

  • Auckland City Hospital

    Auckland, 1023, New Zealand

  • Azienda Ospedaliera per l Emergenza Cannizzaro

    Catania, 95126, Italy

  • Barts Health NHS Trust - St Bartholomew s Hospital

    London, EC1A 7BE, United Kingdom

  • Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi

    Adana, 01250, Turkey (Türkiye)

  • Baskent Universitesi Ankara Hastanesi

    Ankara, 06490, Turkey (Türkiye)

  • Beskidzkie Centrum Onkologii im. Jana Pawla II

    Bielsko-Biala, 43-300, Poland

  • Biomelab S A S

    Barranquilla, 08002, Colombia

  • CHU de Quebec-Universite Laval-Hotel Dieu de Quebec

    Québec, G1R 2J6, Canada

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

    Montreal, Quebec, H1T 2M4, Canada

  • CIUSSS de l'Estrie-CHUS

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie

    Plérin, 22190, France

  • Centre Eugene Marquis

    Rennes, 35042, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310, France

  • Centre Hospitalier de l Universite de Montreal - CHUM

    Montreal, Quebec, H2X 3E4, Canada

  • Centre Leon Berard

    Lyon, 69008, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Centre de Lutte Contre le Cancer Francois Baclesse

    Caen, 14076, France

  • Centro Hemato Oncologico Privado

    Toluca, 50080, Mexico

  • Centro Oncologico Riojano Integral

    La Rioja, F5300COE, Argentina

  • Centro de Oncologia e Investigacion Buenos Aires COIBA

    Berazategui, Buenos Aires, B1884BBF, Argentina

  • Centrum Onkologii Instytut im. Marii Sklodowskiej Curie

    Krakow, Lesser Poland Voivodeship, 31-115, Poland

  • Centrum Onkologii Instytut im. Marii Sklodowskiej Curie

    Gliwice, 44-101, Poland

  • Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Chaim Sheba Medical Center

    Ramat Gan, 5262000, Israel

  • Chang Gung Medical Foundation. Linkou Branch

    Taoyuan, 33305, Taiwan

  • Clinica Colsanitas S.A. - Sede Clinica Universitaria Colombia

    Bogotá, 111321, Colombia

  • Clinica Universitaria Navarra - Madrid

    Madrid, 28027, Spain

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

    São Paulo, São Paulo, 01317-000, Brazil

  • Clinica del Country

    Bogota, Cundinamarca, 110221, Colombia

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • EISAI Trial Site 1

    Erlangen, Germany

  • EISAI Trial Site 1

    Hidaka, Saitama, Japan

  • EISAI Trial Site 10

    Tokyo, Japan

  • EISAI Trial Site 11

    Sapporo, Hokkaido, Japan

  • EISAI Trial Site 12

    Tokyo, Japan

  • EISAI Trial Site 13

    Tokyo, Japan

  • EISAI Trial Site 14

    Sendai, Miyagi, Japan

  • EISAI Trial Site 15

    Tōon, Ehime, Japan

  • EISAI Trial Site 16

    Kagoshima, Japan

  • EISAI Trial Site 17

    Tsukuba, Ibaraki, Japan

  • EISAI Trial Site 18

    Kashiwa, Chiba, Japan

  • EISAI Trial Site 19

    Isehara, Kanagawa, Japan

  • EISAI Trial Site 2

    Dresden, Germany

  • EISAI Trial Site 2

    Sunto-gun, Shizuoka, Japan

  • EISAI Trial Site 3

    Rostock, Germany

  • EISAI Trial Site 3

    Niigata, Japan

  • EISAI Trial Site 4

    Berlin, Germany

  • EISAI Trial Site 4

    Morioka, Iwate, Japan

  • EISAI Trial Site 5

    Tübingen, Germany

  • EISAI Trial Site 5

    Kurume, Fukoka, Japan

  • EISAI Trial Site 6

    Hamburg, Germany

  • EISAI Trial Site 6

    Tokyo, Japan

  • EISAI Trial Site 7

    Matsuyama, Ehime, Japan

  • EISAI Trial Site 8

    Akashi, Hyōgo, Japan

  • EISAI Trial Site 9

    Nagoya, Aichi-ken, Japan

  • Edith Wolfson Medical Center

    Holon, 5822012, Israel

  • Ege Universitesi Tip Fakultesi

    Izmir, 35040, Turkey (Türkiye)

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

    Moscow, 115478, Russia

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

    Moscow, 115682, Russia

  • Faculdade de Medicina da Universidade Federal de Minas Gerais

    Belo Horizonte, 30130-100, Brazil

  • Faicic S de RL de CV

    Veracruz, 91900, Mexico

  • Florence Nightingale Gayrettepe Hastanesi

    Istanbul, 34349, Turkey (Türkiye)

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Fundacao Dr Amaral Carvalho

    Jaú, São Paulo, 17210-080, Brazil

  • Fundacion Colombiana de Cancerologia Clinica Vida

    Medellín, 50032, Colombia

  • Fundacion Valle del Lili

    Cali, Valle del Cauca Department, 760032, Colombia

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912, United States

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204, United States

  • Groupe Hospitalier Broca Cochin Hotel Dieu

    Paris, 75014, France

  • Grupo Medico Camino SC

    Mexico City, 3310, Mexico

  • Guy s & St Thomas NHS Foundation Trust

    London, SE1 9RT, United Kingdom

  • Hacettepe University Medical Faculty

    Ankara, 06000, Turkey (Türkiye)

  • Hadassah Medical Center. Ein Kerem

    Jerusalem, 9112001, Israel

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666, United States

  • Hopital Diaconesses Croix Saint Simon

    Paris, 75020, France

  • Hopital prive du Confluent

    Nantes, 44277, France

  • Hospital Aleman

    Buenos Aires, C1118AAT, Argentina

  • Hospital Araujo Jorge

    Goiânia, Goiás, 74175-120, Brazil

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital General Universitari Vall d Hebron

    Barcelona, 8035, Spain

  • Hospital Privado de la Comunidad

    Mar del Plata, Buenos Aires, B7602CBM, Argentina

  • Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Universitario y Politecnico La Fe de Valencia

    Valencia, 46026, Spain

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Imperial College Healthcare NHS Trust

    London, W12 0HS, United Kingdom

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Gustave Roussy

    Villejuif, 94800, France

  • Institut Regional du Cancer de Montpellier - ICM

    Montpellier, 34298, France

  • Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 8908, Spain

  • Instituto Medico Especializado Alexander Fleming

    Buenos Aires, C1426ANZ, Argentina

  • Instituto Nacional do Cancer II

    Rio de Janeiro, Rio de Janeiro, 20220-410, Brazil

  • Instituto de Investigaciones Metabolicas

    Buenos Aires, C1012AAR, Argentina

  • Instituto de Oncologia Angel H. Roffo

    Buenos Aires, C1417DTB, Argentina

  • Instituto do Cancer de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000, Brazil

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338, Poland

  • Investigacion Onco Farmaceutica S de RL de CV

    La Paz, Estado de Baja California, 23040, Mexico

  • Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, 80131, Italy

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014, Italy

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • John Theurer Cancer Center at Hackensack University Med Ctr

    Hackensack, New Jersey, 07601, United States

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

    Kaohsiung City, 833, Taiwan

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813, Taiwan

  • Leningrad Regional Oncology Center

    Saint Petersburg, 191014, Russia

  • London Health Sciences Centre

    London, Ontario, N6A 5W9, Canada

  • Maryland Oncology Hematology, P.A.

    Wheaton, Maryland, 20902, United States

  • Mater Misericordiae University Hospital

    Dublin, D07 R2WY, Ireland

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10022, United States

  • Mordovia Republican Oncological Dispensary

    Saransk, 430032, Russia

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408, South Korea

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • North Shore University Health System

    Evanston, Illinois, 60201, United States

  • Oncomedica S.A.

    Montería, 230002, Colombia

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Ottawa General Hospital

    Ottawa, Ontario, K1H 8L6, Canada

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Policlinico Universitario Agostino Gemelli

    Roma, 168, Italy

  • Pomorski Uniwersytet Medyczny w Szczecinie

    Szczecin, 70-111, Poland

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Rabin Medical Center

    Petah Tikva, 4941492, Israel

  • Rambam Medical Center

    Haifa, 3525408, Israel

  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan

    Ufa, 450054, Russia

  • Republican Clinical Oncology Dispensary of Tatarstan MoH

    Kazan', 420029, Russia

  • Rodrigo Botero SAS

    Medellín, 50015, Colombia

  • Royal Brisbane and Women s Hospital

    Herston, Queensland, 4029, Australia

  • Royal North Shore Hospital

    Sydney, New South Wales, 2065, Australia

  • Royal Sussex County Hospital

    Brighton, BN2 5BE, United Kingdom

  • SPb SBHI City Clinical Oncological Dispensary

    Saint Petersburg, 198255, Russia

  • Samsung Medical Center

    Seoul, 6351, South Korea

  • Sanford Gynecology Oncology

    Sioux Falls, South Dakota, 57104, United States

  • Seoul National University Hospital

    Seoul, 3080, South Korea

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut, 06510, United States

  • Soroka Medical Center

    Beersheba, 84101, Israel

  • St John of God

    Subiaco, Western Australia, 6008, Australia

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • Sunnybrook Health Science Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Szpital Kliniczny im Ks Anny Mazowieckiej

    Warsaw, 00-315, Poland

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

    Gdynia, 81-159, Poland

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, Beitou, 11217, Taiwan

  • Texas Oncology-San Antonio Medical Center

    San Antonio, Texas, 78240, United States

  • Texas Oncology-South Austin

    Austin, Texas, 78745, United States

  • The Royal Marsden Foundation Trust

    London, SM2 5PT, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2, Canada

  • Tomsk National Research Medical Center of Russian Academy of Sciences

    Tomsk, 624028, Russia

  • UT West Cancer Center

    Germantown, Tennessee, 38138, United States

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • University College Hospital

    London, WC1E 6AG, United Kingdom

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD, United Kingdom

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112, United States

  • University of California Los Angeles

    Santa Monica, California, 90095, United States

  • University of California San Francisco

    San Francisco, California, 94158, United States

  • University of Miami Health System

    Miami, Florida, 33136, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390-9032, United States

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106, United States

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401, United States

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