Spots Global Cancer Trial Database for Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)
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Trial Identification
Brief Title: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)
Official Title: A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared With Standard of Care as First-line Intervention in Participants With Metastatic Esophageal Carcinoma
Study ID: NCT04949256
Study Description
Brief Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Detailed Description: There will be 2 parts to the study: the cisplatin and 5-fluorouracil (5-FU) (FP) and paclitaxel and cisplatin (TP) Safety Run-in (Part 1) and the Main Study (Part 2). In Part 1 (FP and TP Safety Run-in), participants will be treated with pembrolizumab plus lenvatinib plus FP or TP. Dose-limiting toxicities, safety, and tolerability will be assessed. In Part 2 (Main Study), participants (not including those participating in Part 1) will be treated with pembrolizumab plus lenvatinib plus chemotherapy or pembrolizumab plus chemotherapy. Efficacy, safety, and tolerability will be assessed.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope ( Site 0102), Duarte, California, United States
MedStar Washington Hospital Center ( Site 0186), Washington, District of Columbia, United States
James Graham Brown Cancer Center ( Site 0117), Louisville, Kentucky, United States
Norton Cancer Institute ( Site 0116), Louisville, Kentucky, United States
Johns Hopkins Bayview Medical Center ( Site 0152), Baltimore, Maryland, United States
UMASS Memorial Medical Center ( Site 0120), Worcester, Massachusetts, United States
Capital Health Medical Center - Hopewell ( Site 0189), Pennington, New Jersey, United States
Hematology-Oncology Associates of CNY ( Site 0173), East Syracuse, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0132), New York, New York, United States
Weill Cornell Medical College ( Site 0133), New York, New York, United States
St. Luke's University Health Network ( Site 0185), Bethlehem, Pennsylvania, United States
AHN Allegheny General Hospital ( Site 0164), Pittsburgh, Pennsylvania, United States
Medical University of South Carolina-Hollings Cancer Center ( Site 0177), Charleston, South Carolina, United States
VCU Health Adult Outpatient Pavillion ( Site 0160), Richmond, Virginia, United States
Seattle Cancer Care Alliance ( Site 0145), Seattle, Washington, United States
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0203), Berazategui, Buenos Aires, Argentina
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202), Caba, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0205), Mar del Plata, Buenos Aires, Argentina
Fundacion Estudios Clinicos-Oncology ( Site 0215), Rosario, Santa Fe, Argentina
Sanatorio Parque ( Site 0206), Rosario, Santa Fe, Argentina
Hospital Provincial del Centenario ( Site 0217), Rosario, Santa Fe, Argentina
Fundacion Favaloro ( Site 0201), Buenos Aires, , Argentina
Fundación Respirar ( Site 0216), Buenos Aires, , Argentina
Hospital Italiano de Córdoba ( Site 0218), Cordoba, , Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0221), La Rioja, , Argentina
Instituto San Marcos ( Site 0213), San Juan, , Argentina
CancerCare Manitoba ( Site 0001), Winnipeg, Manitoba, Canada
Princess Margaret Cancer Centre ( Site 0004), Toronto, Ontario, Canada
Hotel-Dieu de Levis ( Site 0013), Levis, Quebec, Canada
James Lind Centro de Investigación del Cáncer ( Site 0412), Temuco, Araucania, Chile
Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0401), Temuco, Araucania, Chile
Fundacion Arturo Lopez Perez FALP ( Site 0403), Santiago, Region M. De Santiago, Chile
Oncovida ( Site 0413), Santiago, Region M. De Santiago, Chile
Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407), Santiago, Region M. De Santiago, Chile
Bradford Hill Centro de Investigaciones Clinicas ( Site 0404), Santiago, Region M. De Santiago, Chile
Anhui Cancer Hospital ( Site 8058), Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University ( Site 8026), Hefei, Anhui, China
Beijing Cancer Hospital ( Site 8001), Beijing, Beijing, China
Fujian Provincial Cancer Hospital ( Site 8029), Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University ( Site 8003), Xiamen, Fujian, China
Zhongshan Hospital Affiliated to Xiamen University ( Site 8055), Xiamen, Fujian, China
The First Affiliated Hospital.Sun Yat-sen University ( Site 8047), Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital ( Site 8031), Guangzhou, Guangdong, China
The Third Xiangya Hospital of Central South University ( Site 8046), Changsha, Hainan, China
The First Affiliated Hospital of Hainan Medical University ( Site 8042), Haikou, Hainan, China
Affiliated Hospital of Chengde Medical Univeristy ( Site 8053), Chengde, Hebei, China
Harbin Medical University Cancer Hospital ( Site 8009), Harbin, Heilongjiang, China
Anyang Cancer Hospital ( Site 8006), Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science &Technology-Tumor ( Site 8036), Luoyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University ( Site 8018), Xinxiang, Henan, China
Tongji Medical College Huazhong Uinversity Of Science and Technology ( Site 8025), Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 8014), Wuhan, Hubei, China
Affiliated hospital of Jiangnan university ( Site 8049), Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University ( Site 8015), Xuzhou, Jiangsu, China
Jilin Cancer Hospital ( Site 8016), Changchun, Jilin, China
Jinan Central Hospital ( Site 8052), Jinan, Shandong, China
Shandong Cancer Hospital ( Site 8060), Jinan, Shandong, China
Affiliated Hospital of Jining Medical University ( Site 8017), Jining, Shandong, China
Linyi Cancer Hospital- Medical Oncology Department ( Site 8051), Linyi, Shandong, China
Shanxi Provincial Cancer Hospital ( Site 8019), Taiyuan, Shanxi, China
West China Hospital of Sichuan University ( Site 8048), Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital ( Site 8035), Tianjin, Tianjin, China
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 8041), Urumqi, Xinjiang, China
Sir Run Run Shaw Hospital ( Site 8021), Hangzhou, Zhejiang, China
ICIMED-Oncology Research Unit ( Site 0903), San José, San Jose, Costa Rica
PROCLINICAL Pharma ( Site 0904), San José, San Jose, Costa Rica
CIMCA Centro de Investigacion y Manejo del Cancer ( Site 0902), San Jose, , Costa Rica
Onco Tech S A ( Site 0901), San Jose, , Costa Rica
Rigshospitalet ( Site 2102), Copenhagen, Hovedstaden, Denmark
Odense University Hospital ( Site 2101), Odense, Syddanmark, Denmark
Institut De Cancerologie De Lorraine ( Site 1010), Vandoeuvre les Nancy, Ain, France
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1014), Strasbourg, Alsace, France
C.H. regional Unv. de Brest - Hopital La Cavale Blanche - Institut de Cancerologie et d Imagerie ( S, Brest, Bretagne, France
Centre François Baclesse ( Site 1009), Caen, Calvados, France
Centre Georges Francois Leclerc ( Site 1008), Dijon, Cote-d Or, France
CHU Besançon ( Site 1015), Besançon, Franche-Comte, France
CHU Bordeaux Haut-Leveque ( Site 1012), Pessac, Gironde, France
Institut du Cancer de Montpellier ( Site 1002), Montpellier, Herault, France
CHRU de Tours - Hopital Bretonneau ( Site 1018), Tours, Indre-et-Loire, France
Institut De Cancerologie De L Ouest ( Site 1003), Saint Herblain, Loire-Atlantique, France
Hôpital Claude Huriez ( Site 1030), Lille, Nord, France
Hopital Henri Mondor ( Site 1007), Creteil, Val-de-Marne, France
Hopital Saint Louis ( Site 1029), Paris, , France
Centro Regional de Sub Especialidades Medicas SA ( Site 0604), Guatemala, Quetzaltenango, Guatemala
Oncomedica ( Site 0602), Guatemala, , Guatemala
Soluciones Gastrointestinales S.A. ( Site 0607), Guatemala, , Guatemala
Medi-K Cayala ( Site 0601), Guatemala, , Guatemala
Queen Mary Hospital ( Site 4001), Hong Kong, , Hong Kong
Queen Elizabeth Hospital. ( Site 4004), Kowloon, , Hong Kong
Pecsi Tudomanyegyetem AOK ( Site 1204), Pecs, Baranya, Hungary
Petz Aladar Egyetemi Oktato Korhaz ( Site 1210), Gyor, Gyor-Moson-Sopron, Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1203), Szolnok, Jasz-Nagykun-Szolnok, Hungary
Orszagos Onkologiai Intezet ( Site 1207), Budapest, , Hungary
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1313), Meldola, Emilia-Romagna, Italy
A.O.U. Santa Maria della Misericordia di Udine ( Site 1302), Udine, Friuli-Venezia Giulia, Italy
IRCCS Ospedale San Raffaele di Milano ( Site 1304), Milano, Lombardia, Italy
Humanitas Research Hospital ( Site 1309), Rozzano, Lombardia, Italy
Azienda Ospedaliera Universitaria Pisana ( Site 1312), Pisa, Toscana, Italy
Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 1311), Padova, Veneto, Italy
Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1314), Catanzaro, , Italy
Azienda Ospedaliero Universitaria Careggi ( Site 1301), Firenze, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1306), Milano, , Italy
A.O. Universitaria di Modena ( Site 1307), Modena, , Italy
A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1305), Napoli, , Italy
Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 1310), Roma, , Italy
Aichi Cancer Center Hospital ( Site 9006), Nagoya, Aichi, Japan
Chiba cancer center ( Site 9023), Chiba-shi, Chiba, Japan
National Cancer Center Hospital East ( Site 9002), Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center ( Site 9019), Matsuyama, Ehime, Japan
Hyogo Cancer Center ( Site 9014), Akashi, Hyogo, Japan
Ibaraki Prefectural Central Hospital ( Site 9007), Kasama, Ibaraki, Japan
Kagawa University Hospital ( Site 9015), Kita, Kagawa, Japan
Kanagawa Cancer Center ( Site 9004), Yokohama, Kanagawa, Japan
Tohoku University Hospital ( Site 9013), Sendai-shi, Miyagi, Japan
Niigata Cancer Center Hospital ( Site 9022), Niigata-shi, Niigata, Japan
Kindai University Hospital- Osakasayama Campus ( Site 9017), Osaka-sayama, Osaka, Japan
Osaka University Hospital ( Site 9021), Suita, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 9008), Takatsuki, Osaka, Japan
Saitama Prefectural Cancer Center ( Site 9003), Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center ( Site 9016), Nagaizumi, Shizuoka, Japan
Tokyo Metropolitan Komagome Hospital ( Site 9028), Bunkyo ku, Tokyo, Japan
Toranomon Hospital ( Site 9026), Minato-ku, Tokyo, Japan
Showa University Hospital ( Site 9025), Shinagawa, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center ( Site 9010), Fukuoka, , Japan
University Hospital,Kyoto Prefectural University of Medicine ( Site 9027), Kyoto, , Japan
Kyoto University Hospital ( Site 9011), Kyoto, , Japan
Okayama University Hospital ( Site 9024), Okayama, , Japan
Osaka International Cancer Institute ( Site 9009), Osaka, , Japan
Osaka General Medical Center ( Site 9018), Osaka, , Japan
National Cancer Center Hospital ( Site 9001), Tokyo, , Japan
The Cancer Institute Hospital of JFCR ( Site 9005), Tokyo, , Japan
Keio university hospital ( Site 9020), Tokyo, , Japan
Seoul National University Bundang Hospital ( Site 5006), Seongnam-si, Kyonggi-do, Korea, Republic of
Asan Medical Center ( Site 5002), Songpagu, Seoul, Korea, Republic of
Severance Hospital ( Site 5003), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 5005), Seoul, , Korea, Republic of
Korea University Guro Hospital ( Site 5001), Seoul, , Korea, Republic of
University Malaya Medical Centre ( Site 9101), Lembah Pantai, Kuala Lumpur, Malaysia
Sarawak General Hospital-Radiotherapy Unit ( Site 9100), Kuching, Sarawak, Malaysia
Hospital Kuala Lumpur ( Site 9104), Kuala Lumpur, , Malaysia
Cardiomed SRL Cluj-Napoca-Medical Oncology ( Site 2207), Cluj-Napoca, Cluj, Romania
SC Radiotherapy Center Cluj SRL ( Site 2202), Comuna Floresti, Cluj, Romania
Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 2203), Ovidiu, Constanta, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2204), Craiova, Dolj, Romania
Policlinica Oncomed SRL ( Site 2206), Timisoara, Timis, Romania
S.C.Focus Lab Plus S.R.L ( Site 2201), Bucuresti, , Romania
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507), Ufa, Baskortostan, Respublika, Russian Federation
GBUZ LOKB ( Site 1502), Saint-Petersburg, Leningradskaya Oblast, Russian Federation
FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1510), Moscow, Moskva, Russian Federation
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1503), Saint Petersburg, Sankt-Peterburg, Russian Federation
Academician I.P. Pavlov First St. Petersburg State Medical University ( Site 1519), Saint-Petersburg, Sankt-Peterburg, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1509), Kazan, Tatarstan, Respublika, Russian Federation
SAIH of Tyumen reg "Multifield clinical medical center "Medical city" ( Site 1520), Tyumen, Tyumenskaya Oblast, Russian Federation
National Cancer Centre Singapore ( Site 9201), Singapore, Central Singapore, Singapore
The Oncology Centre ( Site 9505), Durban, Kwazulu-Natal, South Africa
Hospital Universitario General de Asturias ( Site 1601), Oviedo, Asturias, Spain
Hospital Universitario Marques de Valdecilla ( Site 1602), Santander, Cantabria, Spain
Complexo Hospitalario Universitario de Ourense-MEDICAL ONCOLOGY ( Site 1609), Ourense, Orense, Spain
Hospital General Universitari Vall d Hebron ( Site 1607), Barcelona, , Spain
Hospital General Universitario Gregorio Maranon ( Site 1604), Madrid, , Spain
Hospital Virgen del Rocio ( Site 1606), Sevilla, , Spain
Chi Mei Hospital - Liouying Branch-Clinical Trial Center ( Site 6007), Tainan City, Tainan, Taiwan
Chang Gung Med Foundation. Kaohsiung Branch ( Site 6005), Kaohsiung, , Taiwan
China Medical University Hospital ( Site 6003), Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 6004), Tainan, , Taiwan
National Taiwan University Hospital ( Site 6001), Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 6006), Taipei, , Taiwan
Faculty of Medicine Siriraj Hospital ( Site 7002), Bangkok, Krung Thep Maha Nakhon, Thailand
Songklanagarind hospital ( Site 7001), Hatyai, Songkhla, Thailand
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1714), Adana, , Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1701), Ankara, , Turkey
Memorial Ankara Hastanesi ( Site 1702), Ankara, , Turkey
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1715), Ankara, , Turkey
Atatürk Üniversitesi-onkoloji ( Site 1712), Erzurum, , Turkey
Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 1716), Istanbul, , Turkey
Istanbul Okmeydanı Egitim ve Arastirma Hastanesi ( Site 1711), Istanbul, , Turkey
Medeniyet Universitesi Tip Fakultesi ( Site 1703), İstanbul, , Turkey
Chernihiv Medical Center of Modern Oncology ( Site 1811), Chernihiv, Chernihivska Oblast, Ukraine
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 1804), Kryviy Rih, Dnipropetrovska Oblast, Ukraine
Kharkiv Regional Clinical Oncology Center ( Site 1812), Kharkiv, Kharkivska Oblast, Ukraine
Institute of General and Emergency Surgery n.a Zaitsev NAMS of Ukraine ( Site 1813), Kharkiv, Kharkivska Oblast, Ukraine
Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (, Antonivka Village, Khersonska Oblast, Ukraine
SNPE National Cancer Institute ( Site 1806), Kyiv, Kyivska Oblast, Ukraine
Podillya Regional Center of Oncology ( Site 1809), Vinnytsia, Vinnytska Oblast, Ukraine
Volyn Regional Oncological Dispensary ( Site 1816), Lutsk, Volynska Oblast, Ukraine
Cambridge University Hospitals NHSFT ( Site 1908), Cambridge, Cambridgeshire, United Kingdom
Ninewells Hospital and Medical School ( Site 1907), Dundee, Dundee City, United Kingdom
Nottingham University Hospital NHS Trust ( Site 1910), Nottingham, England, United Kingdom
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1915), London, London, City Of, United Kingdom
University College London Hospitals NHS Foundation Trust ( Site 1901), London, London, City Of, United Kingdom
Royal Marsden NHS Foundation Trust ( Site 1905), London, London, City Of, United Kingdom
Royal Marsden NHS Trust. ( Site 1906), Sutton, London, City Of, United Kingdom
Western General Hospital ( Site 1912), Edinburgh, Midlothian, United Kingdom
The Christie NHS Foundation Trust ( Site 1909), Manchester, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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