Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011)
NCT ID: NCT03898180
Last Updated: 2026-02-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
505 participants
INTERVENTIONAL
2019-05-06
2024-05-20
Brief Summary
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The primary hypotheses for this study are that:
1. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR), and
2. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Overall Survival (OS).
Based on recommendation of the external Data Monitoring Committee (eDMC), Amendment 3 (effective: September \[Sep\]-24-2021) was implemented to unblind the study and discontinue lenvatinib and placebo treatment. The eDMC was then disbanded.
With Amendment 4 (effective: December-5-2022) second course pembrolizumab will no longer be offered. Any participant receiving second course pembrolizumab treatment prior to initiation of Amendment 4 will be able to complete treatment as planned. Study participation will end after the final administration of pembrolizumab. Participants who either complete 35 administrations of pembrolizumab or discontinue pembrolizumab will discontinue from the study following the safety follow-up visit. AEs and spontaneously reported pregnancies will be reported and followed per protocol. The overall study ends when the last participant completes the last study-related contact or visit, withdraws from the study, or is lost to follow-up.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Pembrolizumab + Lenvatinib
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue lenvatinib.
Pembrolizumab
IV infusion
Lenvatinib
oral capsule
Pembrolizumab + Placebo
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years) PLUS placebo for lenvatinib via oral capsule QD until progressive disease or discontinuation. With protocol amendment 3 (effective: Sep-24-2021), participants discontinue placebo.
Pembrolizumab
IV infusion
Placebo for lenvatinib
oral capsule
Interventions
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Pembrolizumab
IV infusion
Lenvatinib
oral capsule
Placebo for lenvatinib
oral capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has ≥1 measurable target lesion per RECIST 1.1 as assessed by the local site investigator/radiologist.
* Has provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated and adequate for Programmed Death-Ligand 1 (PD-L1) evaluation.
* Has received no prior systemic chemotherapy for advanced or metastatic UC with the following exceptions:
* Neoadjuvant (prior to surgery) platinum-based chemotherapy for treatment of muscle-invasive bladder cancer with recurrence \>12 months from completion of the therapy is permitted.
* Adjuvant (following surgery) platinum-based chemotherapy following radical cystectomy, with recurrence \>12 months from completion of the therapy, is permitted.
* Meets criteria for either option a or option b (below):
* a. Has a tumor(s) with PD-L1 combined positive score (CPS) ≥10 and is considered ineligible to receive cisplatin-based combination therapy, based on 1 of the following:
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 2 within 7 days prior to randomization
* National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Grade ≥2 audiometric hearing loss
* NCI CTCAE Version 4.0 Grade ≥2 peripheral neuropathy OR
* b. In the opinion of the investigator, is considered ineligible to receive any platinum-based chemotherapy (i.e., ineligible for cisplatin and carboplatin) based on:
* ECOG PS of 2 within 7 days prior to randomization and ≥1 of the following:
* Documented visceral metastatic disease
* NCI CTCAE Version 4.0 Grade ≥2 audiometric hearing loss
* NCI CTCAE Version 4.0 Grade ≥2 peripheral neuropathy
* Other reason for the participant's being unable to receive both cisplatin and carboplatin safely. Additional criteria for platinum ineligibility will be considered and allowed on a case-by-case basis, following consultation with the Sponsor. Note: Participants considered ineligible for any platinum-based chemotherapy are eligible for this study regardless of their tumor PD-L1 status.
* Has ECOG PS 0, 1, or 2 within 7 days prior to randomization and a life expectancy of ≥3 months.
* Male participants are eligible to participate if they agree to the following during the treatment period and for ≥30 days after the last dose of pembrolizumab or lenvatinib/placebo:
* Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR
* Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause as detailed below:
* Agrees to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.
* A female participant is eligible to participate if she is not pregnant or breastfeeding and if she is not a WOCBP OR is a WOCBP and is using a contraceptive method that is highly effective (with a failure rate of \<1% per year) with low user dependency, or is abstinent from heterosexual intercourse as her preferred and usual lifestyle during the intervention period and for ≥120 days post pembrolizumab or ≥30 days post lenvatinib/placebo.
* Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg at screening and no change in antihypertensive medications within 1 week prior to randomization.
* Has adequate organ function.
Exclusion Criteria
* Has tumor with any neuroendocrine or small cell component.
* Has a history of a gastrointestinal condition or procedure (e.g. gastric bypass, malabsorption) that, in the opinion of the investigator, may affect oral drug absorption.
* Has had major surgery within 3 weeks prior to the first dose of study treatment
* Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula.
* Has radiographic evidence of major blood vessel invasion/infiltration, or has had clinically significant hemoptysis (≥0.5 teaspoon of bright red blood) or tumor bleeding within 2 weeks prior to the first dose of study treatment.
* Has had significant cardiovascular impairment within 12 months of the first dose of study treatment, such as history of New York Heart Association (NYHA) \>Class II congestive heart failure, unstable angina, myocardial infarction or cerebrovascular accident (CVA)/stroke, cardiac revascularization procedure, or cardiac arrhythmia associated with hemodynamic instability.
* Has known intolerance or severe hypersensitivity (Grade ≥3) to pembrolizumab or lenvatinib or any of their excipients
* Has received lenvatinib as monotherapy or in combination with a programmed cell death-1/programmed cell death-ligand 1 (PD-1/PD-L1) inhibitor or has previously been enrolled in a clinical study evaluating lenvatinib for bladder cancer, regardless of the treatment received.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 inhibitor, indoleamine-pyrrole 2,3 dioxygenase (IDO1) inhibitor, or agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen 4 \[CTLA-4\], OX 40, CD137), or any other antibody or drug targeting T-cell costimulatory pathways in the adjuvant or advanced/metastatic setting.
* Has received prior radiotherapy to a metastatic site without the use of chemotherapy radiosensitization within 3 weeks of the first dose of study treatment, with the exception of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks before the start of study treatment. Participants must have recovered from all radiation-related toxicities, and must not require corticosteroids.
* Has received a live vaccine within 30 days prior to the first dose of study treatment.
* In the investigator's judgment, has not recovered from toxicity or other complications from any major surgery prior to starting study treatment.
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
* Has history or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at a dose exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.
* Has had an active malignancy (except locally advanced or metastatic UC) within the past 36 months. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) who have undergone potentially curative therapy are not excluded.
* Has a history of prostate cancer (T2NXMX or lower with Gleason score ≤7) treated with definitive intent (surgically or with radiation therapy) ≥1 year prior to study entry is acceptable, provided that the participant is considered prostate cancer-free.
* Has central nervous system (CNS) metastases, unless the participant has completed local therapy (e.g. whole brain radiation therapy, surgery, or radiosurgery) and has discontinued use of corticosteroids for this indication for ≥4 weeks before starting study treatment. Any signs (e.g. radiologic) or symptoms of CNS metastases must be stable for ≥4 weeks before starting study treatment.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with disease-modifying agents, corticosteroids, or immunosuppressive drugs).
* Has a history of (non-infectious) pneumonitis that required systemic steroids, or current pneumonitis.
* Has an active infection requiring systemic therapy.
* Has a known history of human immunodeficiency virus (HIV) infection.
* Has a known history of or is positive for active hepatitis B virus (HBV) or has active hepatitis C virus (HCV).
* Has active tuberculosis (TB).
* Is receiving hemodialysis.
* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of pembrolizumab and lenvatinib/placebo.
* Has had an allogeneic tissue/solid organ transplant.
18 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Banner MD Anderson Cancer Center ( Site 0016)
Gilbert, Arizona, United States
Community Cancer Institute ( Site 0777)
Clovis, California, United States
University of California Irvine Medical Center ( Site 0078)
Orange, California, United States
John Wayne Cancer Institute ( Site 0017)
Santa Monica, California, United States
Northwest Georgia Oncology Centers PC ( Site 0707)
Marietta, Georgia, United States
University of Chicago ( Site 0039)
Chicago, Illinois, United States
Joliet Oncology Hematology ( Site 0091)
Joliet, Illinois, United States
Quincy Medical Group ( Site 0022)
Quincy, Illinois, United States
New England Cancer Specialists ( Site 0047)
Scarborough, Maine, United States
Karmanos Cancer Institute ( Site 0712)
Detroit, Michigan, United States
Mercy Hospital Saint Louis - David C. Pratt Cancer Center ( Site 0095)
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada ( Site 0005)
Las Vegas, Nevada, United States
St. Peter's Hospital Cancer Care Center ( Site 0042)
Albany, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0002)
New York, New York, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0774)
Tulsa, Oklahoma, United States
Thomas Jefferson University Hospital ( Site 0051)
Philadelphia, Pennsylvania, United States
Medical University of South Carolina-Hollings Cancer Center ( Site 0029)
Charleston, South Carolina, United States
Baylor Scott & White Medical Center - Temple ( Site 0706)
Temple, Texas, United States
Virginia Cancer Institute ( Site 0099)
Richmond, Virginia, United States
Seattle Cancer Care Alliance ( Site 0003)
Seattle, Washington, United States
Cancer Care Northwest ( Site 0009)
Spokane, Washington, United States
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0577)
Berazategui, Buenos Aires, Argentina
Centro de Urología CDU ( Site 0590)
Buenos Aires, Buenos Aires F.D., Argentina
Instituto Medico Alexander Fleming ( Site 0578)
Buenos Aires, Buenos Aires F.D., Argentina
Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0585)
Viedma, Río Negro Province, Argentina
Centro Oncológico de Rosario ( Site 0584)
Rosario, Santa Fe Province, Argentina
Instituto de Investigaciones Metabolicas ( Site 0589)
Buenos Aires, , Argentina
Centro Medico Dra De Salvo ( Site 0593)
Buenos Aires, , Argentina
CEMAIC ( Site 0581)
Córdoba, , Argentina
Centro Oncologico de Integracion Regional. COIR ( Site 0576)
Mendoza, , Argentina
Macquarie University ( Site 0151)
North Ryde, New South Wales, Australia
Mater Misericordiae Ltd ( Site 0158)
South Brisbane, Queensland, Australia
Monash Health ( Site 0160)
Clayton, Victoria, Australia
Peninsula Health Frankston Hospital ( Site 0153)
Frankston, Victoria, Australia
Austin Health-Austin Hospital ( Site 0154)
Heidelberg, Victoria, Australia
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0101)
Hamilton, Ontario, Canada
Lakeridge Health ( Site 0103)
Oshawa, Ontario, Canada
Sunnybrook Research Institute ( Site 0106)
Toronto, Ontario, Canada
CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0104)
Québec, Quebec, Canada
CIUSSS de l Estrie Centre Hospitalier Universitaire de Sherbrooke ( Site 0102)
Sherbrooke, Quebec, Canada
Peking University First Hospital ( Site 0726)
Beijing, Beijing Municipality, China
Fifth Medical Center of CPLA General Hospital ( Site 0732)
Beijing, Beijing Municipality, China
Peking University Third Hospital ( Site 0727)
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital ( Site 0741)
Chongging, Chongqing Municipality, China
The First Affiliated Hospital of Xiamen University ( Site 0743)
Xiamen, Fujian, China
Sun Yat-Sen University Cancer Center ( Site 0752)
Guangdong, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University ( Site 0749)
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 0746)
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital ( Site 0750)
Harbin, Heilongjiang, China
Hubei Cancer Hospital ( Site 0744)
Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 0745)
Changsha, Hunan, China
Nanjing Drum Tower Hospital ( Site 0737)
Nanjing, Jiangsu, China
Fudan University Shanghai Cancer Center ( Site 0721)
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Fudan University ( Site 0725)
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0738)
Xian, Shanxi, China
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 0751)
Ürümqi, Xinjiang, China
Second Affiliated Hospital, Zhejiang University ( Site 0734)
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital ( Site 0735)
Hangzhou, Zhejiang, China
Rigshospitalet ( Site 0680)
Copenhagen, Capital Region, Denmark
Herlev Hospital ( Site 0681)
Herlev, Capital Region, Denmark
Aarhus Universitets hospital ( Site 0683)
Aarhus N, Central Jutland, Denmark
Aalborg Universitets Hospital ( Site 0684)
Aalborg, North Denmark, Denmark
Odense Universitetshospital ( Site 0682)
Odense, Region Syddanmark, Denmark
CHU Poitiers ( Site 0253)
Poitiers, Ain, France
Institut de Cancerologie Strasbourg Europe ( Site 0232)
Strasbourg, Alsace, France
Hopital de la Timone ( Site 0246)
Marseille, Bouches-du-Rhone, France
CHIC Quimper ( Site 0245)
Quimper, Finistere, France
CHU de Bordeaux- Hopital Saint Andre ( Site 0235)
Bordeaux, Gironde, France
Clinique Pasteur ( Site 0252)
Tolouse, Haute-Garonne, France
Centre de Cancerologie du Grand Montpellier ( Site 0249)
Montpellier, Languedoc-Roussillon, France
Centre Rene Gauducheau ICO ( Site 0250)
Saint-Herblain, Loire-Atlantique, France
Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0236)
Angers, Maine-et-Loire, France
Centre D Oncologie de Gentilly ( Site 0240)
Nancy, Meurthe-et-Moselle, France
Centre Hospitalier de la Cote Basque ( Site 0239)
Bayonne, Pyrenees-Atlantiques, France
Centre Leon Berard ( Site 0244)
Lyon, Rhone, France
Institut Gustave Roussy ( Site 0243)
Villejuif, Val-de-Marne, France
CHD Vendee-onco-hematologie ( Site 0251)
La Roche-sur-Yon, Vendee, France
Institut Curie ( Site 0237)
Paris, , France
Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0271)
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Giessen und Marburg GmbH ( Site 0284)
Marburg, Hesse, Germany
Universitaetsmedizin Goettingen ( Site 0281)
Göttingen, Lower Saxony, Germany
Helios Kliniken Schwerin GmbH ( Site 0278)
Schwerin, Mecklenburg-Vorpommern, Germany
Universitaetsklinikum Essen ( Site 0274)
Essen, North Rhine-Westphalia, Germany
Staedtisches Krankenhaus Kiel GmbH ( Site 0285)
Kiel, Schleswig-Holstein, Germany
Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0277)
Lübeck, Schleswig-Holstein, Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0282)
Hamburg, , Germany
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce
Miskolc, Borsod-Abauj Zemplen county, Hungary
Bacs-Kiskun Megyei Korhaz ( Site 0510)
Kecskemét, Bács-Kiskun county, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0507)
Szolnok, Jász-Nagykun-Szolnok, Hungary
Markusovszky Egyetemi Oktatokorhaz ( Site 0502)
Szombathely, Vas County, Hungary
Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 0509)
Budapest, , Hungary
Orszagos Onkologiai Intezet ( Site 0503)
Budapest, , Hungary
Uzsoki Utcai Korhaz ( Site 0508)
Budapest, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0504)
Kaposvár, , Hungary
Ha Emek Medical Center ( Site 0560)
Afula, , Israel
Assuta Ashdod Public ( Site 0562)
Ashdod, , Israel
Rambam Medical Center ( Site 0552)
Haifa, , Israel
Shaare Zedek Medical Center ( Site 0559)
Jerusalem, , Israel
Hadassah Ein Kerem Medical Center ( Site 0558)
Jerusalem, , Israel
Meir Medical Center ( Site 0554)
Kfar Saba, , Israel
Rabin Medical Center ( Site 0553)
Petah Tikva, , Israel
Sheba Medical Center ( Site 0551)
Ramat Gan, , Israel
Sourasky Medical Center ( Site 0561)
Tel Aviv, , Israel
Assaf Harofeh Medical Center ( Site 0556)
Ẕerifin, , Israel
Ospedale San Raffaele-Oncologia Medica ( Site 0309)
Milan, Lombardy, Italy
ASST Grande Ospedale Metropolitano Niguarda ( Site 0307)
Milan, Lombardy, Italy
Centro di Riferimento Oncologico CRO ( Site 0304)
Aviano, Pordenone, Italy
Istituto Tumori Giovanni Paolo II ( Site 0306)
Bari, , Italy
Policlinico S. Orsola - Malpighi (Bologna) ( Site 0302)
Bologna, , Italy
Azienda Ospedaliera per l Emergenza Cannizzaro ( Site 0305)
Catania, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0301)
Milan, , Italy
Azienda Ospedaliera Santa Maria ( Site 0303)
Terni, , Italy
Ospedale Borgo Roma-Oncologia ( Site 0308)
Verona, , Italy
Hirosaki University Hospital ( Site 0123)
Hirosaki, Aomori, Japan
National Cancer Center Hospital East ( Site 0128)
Kashiwa, Chiba, Japan
Ehime University Hospital ( Site 0137)
Tōon, Ehime, Japan
Sapporo Medical University Hospital ( Site 0122)
Sapporo, Hokkaido, Japan
University of Tsukuba Hospital ( Site 0126)
Tsukuba, Ibaraki, Japan
Kitasato University Hospital ( Site 0129)
Sagamihara, Kanagawa, Japan
Nara Medical University Hospital ( Site 0133)
Kashihara, Nara, Japan
Saitama Medical University International Medical Center ( Site 0125)
Hidaka, Saitama, Japan
Yamaguchi University Hospital ( Site 0135)
Ube, Yamaguchi, Japan
Akita University Hospital ( Site 0124)
Akita, , Japan
Chiba Cancer Center ( Site 0127)
Chiba, , Japan
Nagasaki University Hospital ( Site 0136)
Nagasaki, , Japan
Osaka City University Hospital ( Site 0132)
Osaka, , Japan
Tokushima University Hospital ( Site 0134)
Tokushima, , Japan
Medical Hospital, Tokyo Medical And Dental University ( Site 0130)
Tokyo, , Japan
Ziekenhuis Rijnstate ( Site 0342)
Arnhem, Gelderland, Netherlands
Maastricht Universitair Medisch Centrum - MUMC ( Site 0334)
Maastricht, Limburg, Netherlands
VieCuri Medisch Centrum ( Site 0340)
Venlo, Limburg, Netherlands
Amphia Ziekenhuis Breda ( Site 0331)
Breda, North Brabant, Netherlands
Deventer Ziekenhuis ( Site 0341)
Deventer, Overijssel, Netherlands
Erasmus MC ( Site 0332)
Rotterdam, South Holland, Netherlands
Haga Ziekenhuis ( Site 0333)
The Hague, South Holland, Netherlands
St. Antonius Ziekenhuis ( Site 0335)
Utrecht, , Netherlands
Szpital Wojewodzki ( Site 1062)
Tarnów, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 0535)
Wroclaw, Lower Silesian Voivodeship, Poland
Europejskie Centrum Zdrowia Otwock ( Site 0532)
Otwock, Masovian Voivodeship, Poland
Urologica Praktyka Lekarska Adam Marcheluk ( Site 0543)
Siedlce, Masovian Voivodeship, Poland
Luxmed Onkologia sp. z o. o. ( Site 0541)
Warsaw, Masovian Voivodeship, Poland
Szpital Miejski im. Jana Pawła II w Bielsku-Białej ( Site 0542)
Bielsko-Biala, Silesian Voivodeship, Poland
GBUZ Leningrad Regional Clinical Oncology Dispensary ( Site 0426)
Kuzmolovskiy Settlement, Leningradskaya Oblast', Russia
Russian Scientific Center of Roentgenoradiology ( Site 0424)
Moscow, Moscow, Russia
Central Clinical Hospital with Polyclinic ( Site 0415)
Moscow, Moscow, Russia
Medical Rehabilitation Center ( Site 0411)
Moscow, Moscow, Russia
Murmansk Regional Oncology Dispensary ( Site 0420)
Murmansk, Murmansk Oblast, Russia
Volga District Medical Center Federal Medical and Biological Agency ( Site 0413)
Nizhny Novgorod, Nizhny Novgorod Oblast, Russia
Omsk Clinical Oncology Dispensary ( Site 0418)
Omsk, Omsk Oblast, Russia
Clinical Hospital Saint Luka ( Site 0421)
Saint Petersburg, Sankt-Peterburg, Russia
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0414)
Yaroslavl, Yaroslavl Oblast, Russia
Chonnam National University Hwasun Hospital ( Site 0194)
Hwasun Gun, Jeonranamdo, South Korea
National Cancer Center ( Site 0196)
Goyang-si, Kyonggi-do, South Korea
Chungnam National University Hospital ( Site 0195)
Daejeon, Taejon-Kwangyokshi, South Korea
Korea University Anam Hospital ( Site 0197)
Seoul, , South Korea
Seoul National University Hospital ( Site 0191)
Seoul, , South Korea
Severance Hospital ( Site 0192)
Seoul, , South Korea
Veterans Health Service Medical Center ( Site 0198)
Seoul, , South Korea
Samsung Medical Center ( Site 0193)
Seoul, , South Korea
Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0351)
Badalona, Barcelona, Spain
ICO L Hospitalet ( Site 0361)
L'Hospitalet de Llobregat, Barcelona, Spain
Xarxa Assistencial Universitaria Manresa ( Site 0354)
Manresa, Barcelona, Spain
Hospital Teresa Herrera - Chuac ( Site 0357)
A Coruña, La Coruna, Spain
Hospital Universitario HM Sanchinarro ( Site 0356)
Madrid, Madrid, Comunidad de, Spain
Hospital Infanta Cristina ( Site 0355)
Badajoz, , Spain
Hospital General Universitari Vall d Hebron ( Site 0358)
Barcelona, , Spain
Hospital La Princesa ( Site 0862)
Madrid, , Spain
Hospital Universitario Gregorio Maranon ( Site 0352)
Madrid, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 0216)
Kaoshiung, Kaohsiung, Taiwan
Kaohsiung Chang Gung Memorial Hospital ( Site 0217)
Kaohsiung City, , Taiwan
China Medical University Hospital ( Site 0213)
Taichung, , Taiwan
Taichung Veterans General Hospital ( Site 0214)
Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 0215)
Tainan, , Taiwan
National Taiwan University Hospital ( Site 0211)
Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 0212)
Taipei, , Taiwan
Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 0457)
Adana, , Turkey (Türkiye)
Ankara Sehir Hastanesi ( Site 0455)
Ankara, , Turkey (Türkiye)
Antalya Memorial Hospital Department of Medical Oncology ( Site 0461)
Antalya, , Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0454)
Istanbul, , Turkey (Türkiye)
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0459)
Istanbul, , Turkey (Türkiye)
Ege Universitesi Tulay Aktas Onkoloji Hastanesi ( Site 0462)
Izmir, , Turkey (Türkiye)
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0456)
Konya, , Turkey (Türkiye)
Sakarya Universitesi Tip Fakultesi Arastirma Hastanesi ( Site 0460)
Sakarya, , Turkey (Türkiye)
Weston Park Hospital ( Site 0387)
Sheffield, Derbyshire, United Kingdom
Queens Hospital-Purple Zone ( Site 0377)
Romford, Essex, United Kingdom
Lister Hospital ( Site 0376)
Stevenage, Hertfordshire, United Kingdom
Kent and Canterbury Hospital ( Site 0390)
Canterbury, Kent, United Kingdom
Royal Preston Hospital ( Site 0379)
Preston, Lancashire, United Kingdom
Saint Bartholomew s Hospital - London ( Site 0386)
London, London, City of, United Kingdom
University College London Hospital NHS Foundation Trust ( Site 0380)
London, London, City of, United Kingdom
Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 0378)
London, London, City of, United Kingdom
Nottingham University Hospital NHS Trust ( Site 0383)
Nottingham, , United Kingdom
Derriford Hospital ( Site 0388)
Plymouth, , United Kingdom
Royal Stoke University Hospital Univ. Hosps of North Midlands NHST ( Site 0392)
Stoke-on-Trent, , United Kingdom
Countries
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References
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Matsubara N, de Wit R, Balar AV, Siefker-Radtke AO, Zolnierek J, Csoszi T, Shin SJ, Park SH, Atduev V, Gumus M, Su YL, Karaca SB, Cutuli HJ, Sendur MAN, Shen L, O'Hara K, Okpara CE, Franco S, Moreno BH, Grivas P, Loriot Y. Pembrolizumab with or Without Lenvatinib as First-line Therapy for Patients with Advanced Urothelial Carcinoma (LEAP-011): A Phase 3, Randomized, Double-Blind Trial. Eur Urol. 2024 Mar;85(3):229-238. doi: 10.1016/j.eururo.2023.08.012. Epub 2023 Sep 29.
Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-7902-011
Identifier Type: OTHER
Identifier Source: secondary_id
E7080-G000-317
Identifier Type: OTHER
Identifier Source: secondary_id
LEAP-011
Identifier Type: OTHER
Identifier Source: secondary_id
194808
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-003752-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7902-011
Identifier Type: -
Identifier Source: org_study_id
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