Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
Official Title: A Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011)
Study ID: NCT03898180
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in the treatment of cisplatin-ineligible participants with a Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, or in participants ineligible for any platinum-containing chemotherapy regardless of CPS, with advanced/unresectable or metastatic urothelial carcinoma (UC). 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). With Amendment 3 (effective: September \[Sep\]-24-2021) participants discontinued lenvatinib and placebo; participants who remained on treatment in the study arms received open-label pembrolizumab. With Amendment 3 the external Data Monitoring Committee was discontinued. With Amendment 4 (effective: December-5-2022) Second Course will no longer be offered. Any participant receiving Second Course treatment prior to initiation of Amendment 4 will be able to complete treatment as planned. With Amendment 4 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. All participants in efficacy follow-up prior to initiation of Amendment 4 will stop efficacy assessments and be discontinued from the study. All participants in survival follow-up prior to initiation of Amendment 4 are considered to have completed the study and should have a final survival contact. 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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), Saint 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, Caba, Argentina
Instituto Medico Alexander Fleming ( Site 0578), Buenos Aires, Caba, Argentina
Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0585), Viedma, Rio Negro, Argentina
Centro Oncológico de Rosario ( Site 0584), Rosario, Santa Fe, Argentina
Instituto de Investigaciones Metabolicas ( Site 0589), Buenos Aires, , Argentina
Centro Medico Dra De Salvo ( Site 0593), Buenos Aires, , Argentina
CEMAIC ( Site 0581), Cordoba, , 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
CIUSSS de l Estrie Centre Hospitalier Universitaire de Sherbrooke ( Site 0102), Sherbrooke, Quebec, Canada
CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0104), Quebec, , Canada
Peking University First Hospital ( Site 0726), Beijing, Beijing, China
Fifth Medical Center of CPLA General Hospital ( Site 0732), Beijing, Beijing, China
Peking University Third Hospital ( Site 0727), Beijing, Beijing, China
Chongqing Cancer Hospital ( Site 0741), Chongging, Chongqing, 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, China
Zhongshan Hospital Fudan University ( Site 0725), Shanghai, Shanghai, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0738), Xian, Shanxi, China
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 0751), Urumqi, 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, Hovedstaden, Denmark
Herlev Hospital ( Site 0681), Herlev, Hovedstaden, Denmark
Aarhus Universitets hospital ( Site 0683), Aarhus N, Midtjylland, Denmark
Aalborg Universitets Hospital ( Site 0684), Aalborg, Nordjylland, Denmark
Odense Universitetshospital ( Site 0682), Odense, 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), Tuebingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Giessen und Marburg GmbH ( Site 0284), Marburg, Hessen, Germany
Helios Kliniken Schwerin GmbH ( Site 0278), Schwerin, Mecklenburg-Vorpommern, Germany
Universitaetsmedizin Goettingen ( Site 0281), Gottingen, Niedersachsen, Germany
Universitaetsklinikum Essen ( Site 0274), Essen, Nordrhein-Westfalen, Germany
Staedtisches Krankenhaus Kiel GmbH ( Site 0285), Kiel, Schleswig-Holstein, Germany
Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0277), Luebeck, Schleswig-Holstein, Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0282), Hamburg, , Germany
Bacs-Kiskun Megyei Korhaz ( Site 0510), Kecskemet, Bacs-Kiskun, Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce, Miskolc, Borsod-Abauj-Zemplen, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0507), Szolnok, Jasz-Nagykun-Szolnok, Hungary
Markusovszky Egyetemi Oktatokorhaz ( Site 0502), Szombathely, Vas, 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), Kaposvar, , 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), Petach-Tikwa, , Israel
Sheba Medical Center ( Site 0551), Ramat Gan, , Israel
Sourasky Medical Center ( Site 0561), Tel Aviv, , Israel
Assaf Harofeh Medical Center ( Site 0556), Zerifin, , Israel
Ospedale San Raffaele-Oncologia Medica ( Site 0309), Milano, Lombardia, Italy
ASST Grande Ospedale Metropolitano Niguarda ( Site 0307), Milano, Lombardia, 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), Milano, , 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), Toon, 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
Chonnam National University Hwasun Hospital ( Site 0194), Hwasun Gun, Jeonranamdo, Korea, Republic of
National Cancer Center ( Site 0196), Goyang-si, Kyonggi-do, Korea, Republic of
Chungnam National University Hospital ( Site 0195), Daejeon, Taejon-Kwangyokshi, Korea, Republic of
Korea University Anam Hospital ( Site 0197), Seoul, , Korea, Republic of
Seoul National University Hospital ( Site 0191), Seoul, , Korea, Republic of
Severance Hospital ( Site 0192), Seoul, , Korea, Republic of
Veterans Health Service Medical Center ( Site 0198), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 0193), Seoul, , Korea, Republic of
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, Noord-Brabant, Netherlands
Deventer Ziekenhuis ( Site 0341), Deventer, Overijssel, Netherlands
Haga Ziekenhuis ( Site 0333), Den Haag, Zuid-Holland, Netherlands
Erasmus MC ( Site 0332), Rotterdam, Zuid-Holland, Netherlands
St. Antonius Ziekenhuis ( Site 0335), Utrecht, , Netherlands
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 0535), Wroclaw, Dolnoslaskie, Poland
Szpital Wojewodzki ( Site 1062), Tarnow, Malopolskie, Poland
Europejskie Centrum Zdrowia Otwock ( Site 0532), Otwock, Mazowieckie, Poland
Urologica Praktyka Lekarska Adam Marcheluk ( Site 0543), Siedlce, Mazowieckie, Poland
Luxmed Onkologia sp. z o. o. ( Site 0541), Warszawa, Mazowieckie, Poland
Szpital Miejski im. Jana Pawła II w Bielsku-Białej ( Site 0542), Bielsko-Biala, Slaskie, Poland
GBUZ Leningrad Regional Clinical Oncology Dispensary ( Site 0426), Kuzmolovskiy Settlement, Leningradskaya Oblast, Russian Federation
Russian Scientific Center of Roentgenoradiology ( Site 0424), Moscow, Moskva, Russian Federation
Central Clinical Hospital with Polyclinic ( Site 0415), Moscow, Moskva, Russian Federation
Medical Rehabilitation Center ( Site 0411), Moscow, Moskva, Russian Federation
Murmansk Regional Oncology Dispensary ( Site 0420), Murmansk, Murmanskaya Oblast, Russian Federation
Volga District Medical Center Federal Medical and Biological Agency ( Site 0413), Nizhny Novgorod, Nizhegorodskaya Oblast, Russian Federation
Omsk Clinical Oncology Dispensary ( Site 0418), Omsk, Omskaya Oblast, Russian Federation
Clinical Hospital Saint Luka ( Site 0421), Saint-Petersburg, Sankt-Peterburg, Russian Federation
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0414), Yaroslavl, Yaroslavskaya Oblast, Russian Federation
Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0351), Badalona, Barcelona, Spain
ICO L Hospitalet ( Site 0361), Hospitalet de Llobregat, Barcelona, Spain
Xarxa Assistencial Universitaria Manresa ( Site 0354), Manresa, Barcelona, Spain
Hospital Teresa Herrera - Chuac ( Site 0357), A Coruna, 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, , 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
Ankara Sehir Hastanesi ( Site 0455), Ankara, , Turkey
Antalya Memorial Hospital Department of Medical Oncology ( Site 0461), Antalya, , Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0454), Istanbul, , Turkey
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0459), Istanbul, , Turkey
Ege Universitesi Tulay Aktas Onkoloji Hastanesi ( Site 0462), İzmir, , Turkey
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0456), Konya, , Turkey
Sakarya Universitesi Tip Fakultesi Arastirma Hastanesi ( Site 0460), Sakarya, , Turkey
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
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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