Effekt og sikkerhed af Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Kemoterapi hos deltagere med metastatisk esophageal carcinom (MK-7902-014/E7080-G000-320/LEAP-014)
19. august 2026 opdateret af: Merck Sharp & Dohme LLC
Et fase 3, randomiseret studie til evaluering af effektiviteten og sikkerheden af Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Kemoterapi sammenlignet med standardbehandling som førstelinjeintervention hos deltagere med metastatisk esophageal carcinom
Formålet med denne undersøgelse er at vurdere effektiviteten og sikkerheden af pembrolizumab plus lenvatinib plus kemoterapi sammenlignet med pembrolizumab plus kemoterapi som førstelinjeintervention hos deltagere med metastatisk esophageal carcinom
De primære hypoteser er, at pembrolizumab plus lenvatinib plus kemoterapi er bedre end pembrolizumab plus kemoterapi med hensyn til samlet overlevelse (OS) og progressionsfri overlevelse (PFS) pr. responsevalueringskriterier i solide tumorer Version 1.1 (RECIST 1.1) ved blindet uafhængig central gennemgang (BICR).
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Der vil være 2 dele af undersøgelsen: cisplatin og 5-fluorouracil (5-FU) (FP) og paclitaxel og cisplatin (TP) Safety Run-in (del 1) og hovedundersøgelsen (del 2). I del 1 (FP og TP Safety Run-in) vil deltagerne blive behandlet med pembrolizumab plus lenvatinib plus FP eller TP. Dosisbegrænsende toksicitet, sikkerhed og tolerabilitet vil blive vurderet.
I del 2 (hovedundersøgelse) vil deltagere (ikke inklusive dem, der deltager i del 1) blive behandlet med pembrolizumab plus lenvatinib plus kemoterapi eller pembrolizumab plus kemoterapi. Effektivitet, sikkerhed og tolerabilitet vil blive vurderet.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
863
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires, Argentina, C1093AAS
- Fundacion Favaloro ( Site 0201)
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Buenos Aires, Argentina, C1426ABP
- Fundación Respirar ( Site 0216)
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Córdoba, Argentina, X5004BAL
- Hospital Italiano de Córdoba ( Site 0218)
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La Rioja, Argentina, F5300COE
- Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0221)
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San Juan, Argentina, J5400EBB
- Instituto San Marcos ( Site 0213)
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Buenos Aires
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Berazategui, Buenos Aires, Argentina, B1884BBF
- Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0203)
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CABA, Buenos Aires, Argentina, C1012AAR
- IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202)
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Mar del Plata, Buenos Aires, Argentina, B7600FZO
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205)
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000DEJ
- Fundacion Estudios Clinicos-Oncology ( Site 0215)
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Rosario, Santa Fe Province, Argentina, S2000DSV
- Sanatorio Parque ( Site 0206)
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Rosario, Santa Fe Province, Argentina, S2002KDS
- Hospital Provincial del Centenario ( Site 0217)
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba ( Site 0001)
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Cancer Centre ( Site 0004)
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Quebec
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Lévis, Quebec, Canada, G6V 3Z1
- Hotel-Dieu de Levis ( Site 0013)
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Araucania
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Temuco, Araucania, Chile, 4800827
- James Lind Centro de Investigacion del Cancer ( Site 0412)
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Temuco, Araucania, Chile, 4810218
- Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0401)
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 7500836
- Fundacion Arturo Lopez Perez FALP ( Site 0403)
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Santiago, Region M. de Santiago, Chile, 7510032
- Oncovida ( Site 0413)
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Santiago, Region M. de Santiago, Chile, 7550000
- Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407)
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Santiago, Region M. de Santiago, Chile, 8420383
- Bradford Hill Centro de Investigaciones Clinicas ( Site 0404)
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San José, Costa Rica, 10103
- CIMCA Centro de Investigacion y Manejo del Cancer ( Site 0902)
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San José, Costa Rica, 10103
- Onco Tech S A ( Site 0901)
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Provincia de San José
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San José, Provincia de San José, Costa Rica, 10108
- ICIMED-Oncology Research Unit ( Site 0903)
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San José, Provincia de San José, Costa Rica, 11303
- PROCLINICAL Pharma ( Site 0904)
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Capital Region
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Copenhagen, Capital Region, Danmark, 2100
- Rigshospitalet ( Site 2102)
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Region Syddanmark
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Odense, Region Syddanmark, Danmark, 5000
- Odense University Hospital ( Site 2101)
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Manchester, Det Forenede Kongerige, M20 4BX
- The Christie NHS Foundation Trust ( Site 1909)
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Cambridgeshire
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Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 2QQ
- Cambridge University Hospitals NHSFT ( Site 1908)
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Dundee City
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Dundee, Dundee City, Det Forenede Kongerige, DD2 1SG
- Ninewells Hospital and Medical School ( Site 1907)
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England
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Nottingham, England, Det Forenede Kongerige, NG5 1PF
- Nottingham University Hospital NHS Trust ( Site 1910)
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London, City of
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London, London, City of, Det Forenede Kongerige, EC1A 7BE
- St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1915)
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London, London, City of, Det Forenede Kongerige, NW1 2BU
- University College London Hospitals NHS Foundation Trust ( Site 1901)
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London, London, City of, Det Forenede Kongerige, SW3 6JJ
- Royal Marsden NHS Foundation Trust ( Site 1905)
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Sutton, London, City of, Det Forenede Kongerige, SM2 5PT
- Royal Marsden NHS Trust. ( Site 1906)
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Midlothian
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Edinburgh, Midlothian, Det Forenede Kongerige, EH4 2XU
- Western General Hospital ( Site 1912)
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California
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Duarte, California, Forenede Stater, 91010
- City of Hope ( Site 0102)
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20010
- MedStar Washington Hospital Center ( Site 0186)
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
- James Graham Brown Cancer Center ( Site 0117)
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Louisville, Kentucky, Forenede Stater, 40217
- Norton Cancer Institute ( Site 0116)
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Maryland
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Baltimore, Maryland, Forenede Stater, 21224
- Johns Hopkins Bayview Medical Center ( Site 0152)
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Massachusetts
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Worcester, Massachusetts, Forenede Stater, 01655
- UMASS Memorial Medical Center ( Site 0120)
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New Jersey
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Pennington, New Jersey, Forenede Stater, 08534
- Capital Health Medical Center - Hopewell ( Site 0189)
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New York
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East Syracuse, New York, Forenede Stater, 13057
- Hematology-Oncology Associates of CNY ( Site 0173)
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New York, New York, Forenede Stater, 10065
- Memorial Sloan Kettering Cancer Center ( Site 0132)
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New York, New York, Forenede Stater, 10065
- Weill Cornell Medical College ( Site 0133)
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Pennsylvania
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Bethlehem, Pennsylvania, Forenede Stater, 18015
- St. Luke's University Health Network ( Site 0185)
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Pittsburgh, Pennsylvania, Forenede Stater, 15212
- AHN Allegheny General Hospital ( Site 0164)
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina-Hollings Cancer Center ( Site 0177)
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Virginia
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Richmond, Virginia, Forenede Stater, 23219
- VCU Health Adult Outpatient Pavillion ( Site 0160)
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Washington
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Seattle, Washington, Forenede Stater, 98109
- Seattle Cancer Care Alliance ( Site 0145)
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Paris, Frankrig, 75010
- Hopital Saint Louis ( Site 1029)
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Ain
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Vandœuvre-lès-Nancy, Ain, Frankrig, 54519
- Institut De Cancerologie De Lorraine ( Site 1010)
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Alsace
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Strasbourg, Alsace, Frankrig, 67200
- Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1014)
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Calvados
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Caen, Calvados, Frankrig, 14076
- Centre François Baclesse ( Site 1009)
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Cote-d Or
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Dijon, Cote-d Or, Frankrig, 21000
- Centre Georges Francois Leclerc ( Site 1008)
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Finistere
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Brest, Finistere, Frankrig, 29200
- C.H. regional Unv. de Brest - Hopital La Cavale Blanche - Institut de Cancerologie et d Imagerie ( S
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Franche-Comte
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Besançon, Franche-Comte, Frankrig, 25000
- CHU Besançon ( Site 1015)
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Gironde
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Pessac, Gironde, Frankrig, 33604
- CHU Bordeaux Haut-Leveque ( Site 1012)
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Herault
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Montpellier, Herault, Frankrig, 34298
- Institut du Cancer de Montpellier ( Site 1002)
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Indre-et-Loire
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Tours, Indre-et-Loire, Frankrig, 37044
- CHRU de Tours - Hopital Bretonneau ( Site 1018)
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Loire-Atlantique
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Saint-Herblain, Loire-Atlantique, Frankrig, 44805
- Institut De Cancerologie De L Ouest ( Site 1003)
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Nord
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Lille, Nord, Frankrig, 59000
- Hôpital Claude Huriez ( Site 1030)
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Val-de-Marne
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Créteil, Val-de-Marne, Frankrig, 94010
- Hopital Henri Mondor ( Site 1007)
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Guatemala City, Guatemala, 01009
- MEDI-K ( Site 0601)
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Guatemala City, Guatemala, 01010
- Oncomedica ( Site 0602)
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Guatemala City, Guatemala, 01010
- Soluciones Gastrointestinales S.A. ( Site 0607)
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Departamento de Quetzaltenango
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Guatemala, Departamento de Quetzaltenango, Guatemala, 09001
- Centro Regional de Sub Especialidades Medicas SA ( Site 0604)
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Hong Kong, Hong Kong
- Queen Mary Hospital ( Site 4001)
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Kowloon, Hong Kong
- Queen Elizabeth Hospital. ( Site 4004)
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Catanzaro, Italien, 88100
- Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1314)
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Florence, Italien, 50134
- Azienda Ospedaliero Universitaria Careggi ( Site 1301)
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Milan, Italien, 20132
- IRCCS Ospedale San Raffaele di Milano ( Site 1304)
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Milan, Italien, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1306)
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Modena, Italien, 41124
- A.O. Universitaria di Modena ( Site 1307)
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Naples, Italien, 80131
- A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1305)
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Roma, Italien, 00168
- Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 1310)
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Emilia-Romagna
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Meldola, Emilia-Romagna, Italien, 47014
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1313)
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Friuli Venezia Giulia
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Udine, Friuli Venezia Giulia, Italien, 33100
- A.O.U. Santa Maria della Misericordia di Udine ( Site 1302)
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Lombardy
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Rozzano, Lombardy, Italien, 20089
- Humanitas Research Hospital ( Site 1309)
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Tuscany
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Pisa, Tuscany, Italien, 56126
- Azienda Ospedaliera Universitaria Pisana ( Site 1312)
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Veneto
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Padova, Veneto, Italien, 35128
- Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 1311)
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Fukuoka, Japan, 811-1395
- National Hospital Organization Kyushu Cancer Center ( Site 9010)
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Kyoto, Japan, 602-8566
- University Hospital,Kyoto Prefectural University of Medicine ( Site 9027)
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Kyoto, Japan
- Kyoto University Hospital ( Site 9011)
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Okayama, Japan, 700-8558
- Okayama University Hospital ( Site 9024)
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Osaka, Japan, 541-8567
- Osaka International Cancer Institute ( Site 9009)
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Osaka, Japan, 558-8558
- Osaka General Medical Center ( Site 9018)
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Tokyo, Japan, 104-0045
- National Cancer Center Hospital ( Site 9001)
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Tokyo, Japan, 135-8550
- The Cancer Institute Hospital of JFCR ( Site 9005)
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Tokyo, Japan, 160-8582
- Keio University Hospital ( Site 9020)
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 464-8681
- Aichi Cancer Center Hospital ( Site 9006)
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Chiba
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Chiba, Chiba, Japan, 260-8717
- Chiba Cancer Center ( Site 9023)
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Kashiwa, Chiba, Japan, 277-8577
- National Cancer Center Hospital East ( Site 9002)
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Ehime
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Matsuyama, Ehime, Japan, 791-0280
- National Hospital Organization Shikoku Cancer Center ( Site 9019)
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Hyōgo
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Akashi, Hyōgo, Japan, 673-8558
- Hyogo Cancer Center ( Site 9014)
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Ibaraki
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Kasama, Ibaraki, Japan, 309-1793
- Ibaraki Prefectural Central Hospital ( Site 9007)
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Kagawa-ken
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Kita-gun, Kagawa-ken, Japan, 761-0793
- Kagawa University Hospital ( Site 9015)
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Kanagawa
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Yokohama, Kanagawa, Japan, 241-8515
- Kanagawa Cancer Center ( Site 9004)
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Miyagi
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Sendai, Miyagi, Japan, 980-8574
- Tohoku University Hospital ( Site 9013)
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Niigata
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Niigata, Niigata, Japan, 951-8566
- Niigata Cancer Center Hospital ( Site 9022)
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Osaka
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Sayama, Osaka, Japan, 589-8511
- Kindai University Hospital ( Site 9017)
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Suita, Osaka, Japan, 565-0871
- Osaka University Hospital ( Site 9021)
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Takatsuki, Osaka, Japan, 569-8686
- Osaka Medical and Pharmaceutical University Hospital ( Site 9008)
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Saitama
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Kitaadachi-gun, Saitama, Japan, 362-0806
- Saitama Prefectural Cancer Center ( Site 9003)
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Shizuoka
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Nakatogari, Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center ( Site 9016)
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Tokyo
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Bunkyo Ku, Tokyo, Japan, 113-8677
- Tokyo Metropolitan Komagome Hospital ( Site 9028)
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Minato-ku, Tokyo, Japan, 105-8470
- Toranomon Hospital ( Site 9026)
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Shinagawa, Tokyo, Japan, 142-8666
- Showa University Hospital ( Site 9025)
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Anhui
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Hefei, Anhui, Kina, 230031
- Anhui Provincial Cancer Hospital ( Site 8058)
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Hefei, Anhui, Kina, 230031
- The Second Affiliated Hospital of Anhui Medical University ( Site 8026)
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Beijing Cancer Hospital ( Site 8001)
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Fujian
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Fuzhou, Fujian, Kina, 350014
- Fujian Provincial Cancer Hospital ( Site 8029)
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Xiamen, Fujian, Kina, 361004
- Zhongshan Hospital Affiliated to Xiamen University ( Site 8055)
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Xiamen City, Fujian Province, Fujian, Kina, 361003
- The First Affiliated Hospital of Xiamen University ( Site 8003)
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Guangdong
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Guangzhou, Guangdong, Kina, 510080
- The First Affiliated Hospital.Sun Yat-sen University ( Site 8047)
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Guangzhou, Guangdong, Kina, 510515
- Southern Medical University Nanfang Hospital ( Site 8031)
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Hainan
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Changsha, Hainan, Kina, 410013
- The Third Xiangya Hospital of Central South University ( Site 8046)
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Haikou, Hainan, Kina, 570102
- The First Affiliated Hospital of Hainan Medical University ( Site 8042)
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Hebei
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Chengde, Hebei, Kina, 067055
- Affiliated Hospital of Chengde Medical Univeristy ( Site 8053)
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Heilongjiang
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Harbin, Heilongjiang, Kina
- Harbin Medical University Cancer Hospital ( Site 8009)
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Henan
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Anyang, Henan, Kina, 455000
- Anyang Cancer Hospital ( Site 8006)
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Luoyang, Henan, Kina, 471003
- The First Affiliated Hospital of Henan University of Science &Technology-Tumor ( Site 8036)
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Xinxiang, Henan, Kina, 453100
- The First Affiliated Hospital of Xinxiang Medical University ( Site 8018)
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Hubei
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Wuhan, Hubei, Kina, 430030
- Tongji Medical College Huazhong Uinversity Of Science and Technology ( Site 8025)
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Wuhan, Hubei, Kina, 430079
- Hubei Cancer Hospital ( Site 8014)
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Jiangsu
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Wuxi, Jiangsu, Kina, 214122
- Affiliated hospital of Jiangnan university ( Site 8049)
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Xuzhou, Jiangsu, Kina, 221000
- The Affiliated Hospital of Xuzhou Medical University ( Site 8015)
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Jilin
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Changchun, Jilin, Kina, 130012
- Jilin Cancer Hospital ( Site 8016)
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Shandong
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Jinan, Shandong, Kina, 250013
- Jinan Central Hospital ( Site 8052)
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Jinan, Shandong, Kina, 250117
- Shandong Cancer Hospital ( Site 8060)
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Jining, Shandong, Kina, 272000
- Affiliated Hospital of Jining Medical University ( Site 8017)
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Linyi, Shandong, Kina, 276000
- Linyi Cancer Hospital- Medical Oncology Department ( Site 8051)
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Shanxi
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Taiyuan, Shanxi, Kina, 030000
- Shanxi Provincial Cancer Hospital ( Site 8019)
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- West China Hospital of Sichuan University ( Site 8048)
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300060
- Tianjin Medical University Cancer Institute & Hospital ( Site 8035)
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Xinjiang
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Ürümqi, Xinjiang, Kina, 830000
- The Affiliated Cancer Hospital of Xinjiang Medical University. ( Site 8041)
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310016
- Sir Run Run Shaw Hospital ( Site 8021)
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Kuala Lumpur, Malaysia, 50586
- Hospital Kuala Lumpur ( Site 9104)
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Kuala Lumpur
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Lembah Pantai, Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre ( Site 9101)
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Sarawak
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Kuching, Sarawak, Malaysia, 93586
- Sarawak General Hospital-Radiotherapy Unit ( Site 9100)
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Bucharest
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Bucharest, Bucharest, Rumænien, 013812
- MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 2201)
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Cluj
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Cluj-Napoca, Cluj, Rumænien, 400015
- Cardiomed SRL Cluj-Napoca-Medical Oncology ( Site 2207)
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Comuna Floresti, Cluj, Rumænien, 407280
- SC Radiotherapy Center Cluj SRL ( Site 2202)
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Constanța County
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Ovidiu, Constanța County, Rumænien, 905900
- Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 2203)
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Dolj
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Craiova, Dolj, Rumænien, 200542
- S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2204)
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Timiș County
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Timișoara, Timiș County, Rumænien, 300239
- Policlinica Oncomed SRL ( Site 2206)
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Baskortostan, Respublika
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Ufa, Baskortostan, Respublika, Rusland, 450054
- Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507)
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Leningradskaya Oblast'
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Saint-Petersburg, Leningradskaya Oblast', Rusland, 194291
- GBUZ LOKB ( Site 1502)
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Moscow
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Moscow, Moscow, Rusland, 115478
- FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1510)
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, Rusland, 197022
- Academician I.P. Pavlov First St. Petersburg State Medical University ( Site 1519)
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Saint Petersburg, Sankt-Peterburg, Rusland, 197758
- Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1503)
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Tatarstan, Respublika
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Kazan', Tatarstan, Respublika, Rusland, 420029
- Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 150
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Tyumen Oblast
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Tyumen, Tyumen Oblast, Rusland, 625041
- SAIH of Tyumen reg "Multifield clinical medical center "Medical city" ( Site 1520)
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Central Singapore
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Singapore, Central Singapore, Singapore, 168583
- National Cancer Centre Singapore ( Site 9201)
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Barcelona, Spanien, 08035
- Hospital General Universitari Vall d Hebron ( Site 1607)
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Madrid, Spanien, 28007
- Hospital General Universitario Gregorio Maranon ( Site 1604)
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Seville, Spanien, 41013
- Hospital Virgen del Rocio ( Site 1606)
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Cantabria
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Santander, Cantabria, Spanien, 39008
- Hospital Universitario Marques de Valdecilla ( Site 1602)
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Orense
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Ourense, Orense, Spanien, 32005
- Complexo Hospitalario Universitario de Ourense-MEDICAL ONCOLOGY ( Site 1609)
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Principality of Asturias
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Oviedo, Principality of Asturias, Spanien, 33011
- Hospital Universitario General de Asturias ( Site 1601)
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Gauteng
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Johannesburg, Gauteng, Sydafrika, 2193
- Wits Clinical Research ( Site 9502)
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KwaZulu-Natal
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Durban, KwaZulu-Natal, Sydafrika, 4091
- The Oncology Centre ( Site 9505)
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Seoul, Sydkorea, 03722
- Severance Hospital ( Site 5003)
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Seoul, Sydkorea, 06351
- Samsung Medical Center ( Site 5005)
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Seoul, Sydkorea, 08308
- Korea University Guro Hospital ( Site 5001)
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Kyonggi-do
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Seongnam-si, Kyonggi-do, Sydkorea, 13605
- Seoul National University Bundang Hospital ( Site 5006)
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Seoul
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Songpagu, Seoul, Sydkorea, 05505
- Asan Medical Center ( Site 5002)
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Kaohsiung City, Taiwan, 833
- Chang Gung Med Foundation. Kaohsiung Branch ( Site 6005)
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Taichung, Taiwan, 40447
- China Medical University Hospital ( Site 6003)
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital ( Site 6004)
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Taipei, Taiwan, 10002
- National Taiwan University Hospital ( Site 6001)
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital ( Site 6006)
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Tainan
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Tainan, Tainan, Taiwan, 73657
- Chi Mei Hospital - Liouying Branch-Clinical Trial Center ( Site 6007)
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Bangkok
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Bangkok, Bangkok, Thailand, 10700
- Faculty of Medicine Siriraj Hospital ( Site 7002)
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Changwat Songkhla
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Hat Yai, Changwat Songkhla, Thailand, 90110
- Songklanagarind hospital ( Site 7001)
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Adana, Tyrkiet (Türkiye), 01140
- Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1714)
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Ankara, Tyrkiet (Türkiye), 06230
- Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1701)
-
Ankara, Tyrkiet (Türkiye), 06520
- Memorial Ankara Hastanesi ( Site 1702)
-
Ankara, Tyrkiet (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1715)
-
Erzurum, Tyrkiet (Türkiye), 25070
- Atatürk Üniversitesi-onkoloji ( Site 1712)
-
Istanbul, Tyrkiet (Türkiye), 34303
- Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 1716)
-
Istanbul, Tyrkiet (Türkiye), 34384
- Istanbul Okmeydanı Egitim ve Arastirma Hastanesi ( Site 1711)
-
Istanbul, Tyrkiet (Türkiye), 34732
- Medeniyet Universitesi Tip Fakultesi ( Site 1703)
-
-
-
-
-
Kyiv, Ukraine, 03126
- Shalimov Institute of Surgery and Transplantation ( Site 1818)
-
-
Chernihiv Oblast
-
Chernihiv, Chernihiv Oblast, Ukraine, 14029
- Chernihiv Medical Center of Modern Oncology ( Site 1811)
-
-
Chernivetska Oblast
-
Chernivtsi, Chernivetska Oblast, Ukraine, 58013
- Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 1819)
-
-
Dnipropetrovsk Oblast
-
Kryviy Rih, Dnipropetrovsk Oblast, Ukraine, 50048
- MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 1804)
-
-
Kharkiv Oblast
-
Kharkiv, Kharkiv Oblast, Ukraine, 61000
- Kharkiv Regional Clinical Oncology Center ( Site 1812)
-
Kharkiv, Kharkiv Oblast, Ukraine, 61103
- Institute of General and Emergency Surgery n.a Zaitsev NAMS of Ukraine ( Site 1813)
-
-
Kherson Oblast
-
Antonivka Village, Kherson Oblast, Ukraine, 73000
- Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (
-
-
Kyivska Oblast
-
Kyiv, Kyivska Oblast, Ukraine, 03022
- SNPE National Cancer Institute ( Site 1806)
-
-
Rivne Oblast
-
Rivne, Rivne Oblast, Ukraine, 33007
- Rivne Regional Clinical Hospital ( Site 1817)
-
-
Vinnytsia Oblast
-
Vinnytsia, Vinnytsia Oblast, Ukraine, 21029
- Podillya Regional Center of Oncology ( Site 1809)
-
-
Volyn Oblast
-
Lutsk, Volyn Oblast, Ukraine, 43018
- Volyn Regional Oncological Dispensary ( Site 1816)
-
-
-
-
-
Budapest, Ungarn, 1122
- Orszagos Onkologiai Intezet ( Site 1207)
-
-
Baranya
-
Pécs, Baranya, Ungarn, 7624
- Pecsi Tudomanyegyetem AOK ( Site 1204)
-
-
Győr-Moson-Sopron
-
Győr, Győr-Moson-Sopron, Ungarn, 9024
- Petz Aladar Egyetemi Oktato Korhaz ( Site 1210)
-
-
Jász-Nagykun-Szolnok
-
Szolnok, Jász-Nagykun-Szolnok, Ungarn, 5000
- Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1203)
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Har en histologisk eller cytologisk bekræftet diagnose af metastatisk planocellulært karcinom i spiserøret
- Mandlige deltagere afholder sig fra heteroseksuelt samleje eller accepterer at bruge prævention i interventionsperioden og i mindst 7 dage efter den sidste dosis lenvatinib eller 90 dage efter den sidste dosis kemoterapi, alt efter hvad der kommer sidst; 7 dage efter, at lenvatinib er stoppet, hvis deltageren kun tager pembrolizumab og er mere end 90 dage efter kemoterapi, er det ikke nødvendigt med prævention til mænd
- Den kvindelige deltager er ikke gravid eller ammer og er ikke en kvinde i den fødedygtige alder (WOCBP) eller er en WOCBP, der bruger en præventionsmetode, der er yderst effektiv eller afholder sig fra heteroseksuelt samleje som deres foretrukne og sædvanlige livsstil i interventionsperioden og i mindst 120 dage efter den sidste dosis pembrolizumab, 30 dage efter den sidste dosis lenvatinib eller 180 dage efter den sidste dosis kemoterapi, alt efter hvad der indtræffer sidst, og accepterer ikke at donere æg i denne periode
- Har tilstrækkeligt kontrolleret blodtryk (BP) med eller uden antihypertensiv medicin, defineret som BP≤150/90 millimeter kviksølv (mm Hg) uden ændring i antihypertensiv medicin inden for 1 uge før randomisering
- Har tilstrækkelig organfunktion
Ekskluderingskriterier:
- Har tidligere haft behandling for lokalt fremskreden inoperabel eller metastatisk kræft i spiserøret
- Har lokalt fremskreden esophageal carcinom
- Har metastatisk adenocarcinom i spiserøret
- Har direkte invasion i tilstødende organer såsom aorta eller luftrør
- Har røntgenologiske tegn på indkapsling af et større blodkar eller intratumoral kavitation
- Har perforationsrisiko eller betydelig gastrointestinal (GI) blødning
- Har haft klinisk signifikant hæmoptyse inden for 3 uger før den første dosis af undersøgelseslægemidlet eller tumorblødning inden for 2 uger før den første dosis af undersøgelsesinterventionen
- Har ukontrollerbar pleural effusion, perikardiel effusion eller ascites, der kræver hyppig dræning eller medicinsk intervention
- Har GI obstruktion, dårligt oralt indtag, svært ved at tage oral medicin eller eksisterende esophageal stent
- Har haft en større operation, åben biopsi eller betydelig traumatisk skade inden for 3 uger før første dosis af undersøgelsesinterventioner
- Har modtaget tidligere strålebehandling inden for 2 uger efter start af undersøgelsesintervention eller har haft en historie med strålingspneumonitis
- Har modtaget en levende eller levende svækket vaccine inden for 30 dage før den første dosis af undersøgelsesintervention; administration af dræbte vacciner er tilladt
- Har en diagnose af immundefekt eller modtager kronisk systemisk steroidbehandling eller enhver form for immunsuppressiv terapi inden for 7 dage før den første dosis af undersøgelsesintervention, eller har en historie med organtransplantation, inklusive allogen stamcelletransplantation
- Har en kendt yderligere malignitet, der skrider frem eller har krævet aktiv behandling inden for de seneste 3 år
- Har kendte aktive metastaser i centralnervesystemet (CNS) og/eller karcinomatøs meningitis
- Har en aktiv autoimmun sygdom, der har krævet systemisk behandling i de sidste 2 år; erstatningsterapi betragtes ikke som en form for systemisk behandling og er tilladt
- Har en historie med ikke-infektiøs pneumonitis/interstitiel lungesygdom, der krævede steroider eller nuværende pneumonitis/interstitiel lungesygdom
- Har dårligt kontrolleret diarré
- Har klinisk signifikant kardiovaskulær sygdom inden for 12 måneder fra første dosis af undersøgelsesintervention
- Har perifer neuropati ≥grad 2
- Har en kendt historie med human immundefektvirus (HIV) infektion
- Har en kendt historie med Hepatitis B eller kender til aktiv Hepatitis C-virusinfektion
- Har et vægttab på >20% inden for de sidste 3 måneder
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Del 2: Pembrolizumab + Kemoterapi
Deltagerne modtager pembrolizumab 400 mg IV hver 6. uge i 18 cyklusser (hver cykluslængde = 6 uger, ca. 2 år) plus kemoterapi med FP (cisplatin 80 mg/m^2 IV Q3W i op til 6 administrationer [op til ~18 uger] og 5-FU 4000 mg/m^2 IV Q3W i op til 35 indgivelser [op til ~2 år]) eller TP (paclitaxel 175 mg/m^2 og cisplatin 75 mg/m^2 Q3W for op til 6 indgivelser [op til ~18 uger]) eller i kombination med mFOLFOX6 (oxaliplatin 85 mg/m^2, 5-FU 400 mg/m^2 efterfulgt af 2400 mg/m^2 og leucovorin 400 mg/m^2 [eller levoleucovorin 200 mg /m^2] IV Q2W i op til 52 administrationer [ca. 2 år]).
|
4000 mg/m^2 Q3W via IV-infusion, som en del af investigators valg FP-kemoterapi eller 400 mg/m^2 Q2W via bolus IV-infusion efterfulgt af 2400 mg/m^2 Q2W via kontinuerlig IV-infusion, som en del af investigators valg mFOLFOX6 kemoterapi.
Andre navne:
85 mg/m^2 Q2W via IV infusion, som en del af investigators choice mFOLFOX6 kemoterapi.
Andre navne:
400 mg/m^2 Q2W som en del af investigators choice mFOLFOX6 kemoterapi.
Andre navne:
200 mg/m^2 Q2W som en del af investigators choice mFOLFOX6 kemoterapi.
Andre navne:
175 mg/m^2 Q3W via IV-infusion, som en del af investigators choice TP-kemoterapi.
Andre navne:
400 mg én gang hver 6-ugers cyklus via IV infusion.
Andre navne:
|
|
Eksperimentel: Del 1: Pembrolizumab + Lenvatinib + Kemoterapi
I induktionsfasen modtager deltagerne pembrolizumab 400 mg intravenøst (IV) hver 6. uge (Q6W) i 2 cyklusser (hver cykluslængde = 6 uger) plus Lenvatinib 8 mg peroralt (PO) en gang dagligt (QD) plus kemoterapi med FP (cisplatin 80 mg/m² og 5-FU 400 mg/m² efterfulgt af 2400 mg/m²) eller TP (paclitaxel 175 mg/m² og cisplatin 75 mg/m²) IV hver 3. uge i 4 doseringer efter forskerens skøn (ca. 12 uger).
I konsolideringsfasen modtager deltagerne pembrolizumab 400 mg IV Q6W i 16 cyklusser (hver cykluslængde = 6 uger) og Lenvatinib 20 mg PO indtil sygdomsprogression eller afbrydelse (ca. 96 uger).
|
80 mg/m^2 Q3W via IV infusion, som en del af investigators valg FP kemoterapi eller 75 mg/m^2 Q3W via infusion, som del af investigators choice TP kemoterapi.
Andre navne:
4000 mg/m^2 Q3W via IV-infusion, som en del af investigators valg FP-kemoterapi eller 400 mg/m^2 Q2W via bolus IV-infusion efterfulgt af 2400 mg/m^2 Q2W via kontinuerlig IV-infusion, som en del af investigators valg mFOLFOX6 kemoterapi.
Andre navne:
175 mg/m^2 Q3W via IV-infusion, som en del af investigators choice TP-kemoterapi.
Andre navne:
400 mg én gang hver 6-ugers cyklus via IV infusion.
Andre navne:
8 mg QD (Induktion) eller 20 mg QD (Konsolidering) via oral kapsel.
Andre navne:
|
|
Eksperimentel: Del 2: Pembrolizumab + Lenvatinib + Kemoterapi
I induktionsfasen modtager deltagerne pembrolizumab 400 mg intravenøst (IV) hver 6. uge (Q6W) i 2 cyklusser (hver cykluslængde = 6 uger) plus Lenvatinib 8 mg peroralt (PO) én gang dagligt (QD) plus kemoterapi med FP (cisplatin 80 mg/m² og 5-FU 4000 mg/m²) eller TP (paclitaxel 175 mg/m² og cisplatin 75 mg/m²) IV hver 3. uge i 4 administrationer eller mFOLFOX6 (oxaliplatin 85 mg/m², 5-FU 400 mg/m² efterfulgt af 2400 mg/m², og leucovorin 400 mg/m² [eller levoleucovorin 200 mg/m²] én gang hver 2. uge [Q2W] i 6 administrationer efter forsøgslederens skøn (ca. 12 uger).
I konsolideringsfasen modtager deltagerne pembrolizumab 400 mg IV Q6W i 16 cyklusser (hver cykluslængde = 6 uger) og Lenvatinib 20 mg PO indtil progressiv sygdom eller afbrydelse (ca. 96 uger).
|
80 mg/m^2 Q3W via IV infusion, som en del af investigators valg FP kemoterapi eller 75 mg/m^2 Q3W via infusion, som del af investigators choice TP kemoterapi.
Andre navne:
4000 mg/m^2 Q3W via IV-infusion, som en del af investigators valg FP-kemoterapi eller 400 mg/m^2 Q2W via bolus IV-infusion efterfulgt af 2400 mg/m^2 Q2W via kontinuerlig IV-infusion, som en del af investigators valg mFOLFOX6 kemoterapi.
Andre navne:
85 mg/m^2 Q2W via IV infusion, som en del af investigators choice mFOLFOX6 kemoterapi.
Andre navne:
400 mg/m^2 Q2W som en del af investigators choice mFOLFOX6 kemoterapi.
Andre navne:
200 mg/m^2 Q2W som en del af investigators choice mFOLFOX6 kemoterapi.
Andre navne:
175 mg/m^2 Q3W via IV-infusion, som en del af investigators choice TP-kemoterapi.
Andre navne:
400 mg én gang hver 6-ugers cyklus via IV infusion.
Andre navne:
8 mg QD (Induktion) eller 20 mg QD (Konsolidering) via oral kapsel.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Part 1 (FP and TP Safety Run-in): Number of Participants With Dose Limiting Toxicities (DLTs)
Tidsramme: Up to 21 days
|
A DLT is defined as a specific adverse event graded for toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Hematologic DLTs are defined as Grade 4 neutropenia lasting for ≥7 days, Grade 3 or Grade 4 febrile neutropenia, Grade 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia, or Grade 4 anemia.
Other nonhematologic toxicities considered a DLT include any other Grade 4 or Grade 5 toxicity, Grade 3 toxicities lasting >3 days (excluding nausea, vomiting, and diarrhea controlled by medical intervention within 72 hours, and Grade 3 rash in the absence of desquamation with no mucosal involvement), Grade 3 hypertension not able to be controlled by medication, ≥Grade 3 gastrointestinal perforation, ≥Grade 3 wound dehiscence requiring medical or surgical intervention, any grade thromboembolic event or any Grade 3 nonhematologic laboratory value requiring medical intervention or hospitalization.
The number of participants in Part 1 with DLTs are presented.
|
Up to 21 days
|
|
Part 1 (FP and TP Safety Run-in): Number of Participants With Adverse Events (AEs)
Tidsramme: Up to 43 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants in Part 1 with AEs will be presented.
|
Up to 43 months
|
|
Part 1 (FP and TP Safety Run-in): Number of Participants Who Discontinued Study Treatment Due to an AE
Tidsramme: Up to 22 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants in Part 1 who discontinue study treatment due to an AE will be presented.
|
Up to 22 months
|
|
Part 2 (Main Study): Overall Survival (OS) in All Participants
Tidsramme: Up to 42 months
|
OS is defined as the time from randomization to death due to any cause.
OS in Part 2 for all randomized participants are presented based on the Kaplan-Meier method for censored data.
|
Up to 42 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Part 2 (Main Study): Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in All Participants
Tidsramme: Up to 42 months
|
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm.
The appearance of one or more new lesions is also considered PD.
RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
PFS in Part 2 for all randomized participants are presented based on the Kaplan-Meier method for censored data.
|
Up to 42 months
|
|
Part 2 (Main Study): Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR in All Participants
Tidsramme: Up to 42 months
|
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 adjusted to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, as assessed by BICR.
ORR in Part 2 for all randomized participants are presented.
|
Up to 42 months
|
|
Part 2 (Main Study): Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR in All Participants
Tidsramme: Up to 42 months
|
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 by BICR, DOR is defined as the time from first documented evidence of CR or PR until PD or death.
Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of one or more new lesions is also considered PD.
RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
DOR in Part 2 for all randomized participants are presented based on the Kaplan-Meier method for censored data.
|
Up to 42 months
|
|
Part 2 (Main Study): OS in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
Tidsramme: Up to 42 months
|
OS is defined as the time from randomization to death due to any cause.
OS in Part 2 for randomized participants with PD-L1 CPS ≥10 are presented based on the Kaplan-Meier method for censored data.
|
Up to 42 months
|
|
Part 2 (Main Study): PFS Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10
Tidsramme: Up to 42 months
|
PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm.
The appearance of one or more new lesions is also considered PD.
RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
PFS in Part 2 for randomized participants with PD-L1 CPS ≥10 are presented based on the Kaplan-Meier method for censored data.
|
Up to 42 months
|
|
Part 2 (Main Study): ORR Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10
Tidsramme: Up to 42 months
|
ORR is defined as the percentage of participants with CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 adjusted to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, as assessed by BICR.
ORR in Part 2 for randomized participants with PD-L1 CPS ≥10 are presented.
|
Up to 42 months
|
|
Part 2 (Main Study): DOR Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10
Tidsramme: Up to 42 months
|
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 by BICR, DOR is defined as the time from first documented evidence of CR or PR until PD or death.
Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of one or more new lesions is also considered PD.
RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
DOR in Part 2 for randomized participants with PD-L1 CPS ≥10 are presented based on the Kaplan-Meier method for censored data.
|
Up to 42 months
|
|
Part 2 (Main Study): Number of Participants With AEs
Tidsramme: Up to 43 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants in Part 2 with AEs are presented.
|
Up to 43 months
|
|
Part 2 (Main Study): Number of Participants Who Discontinued Study Treatment Due to an AE
Tidsramme: Up to 22 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants in Part 2 who discontinue study treatment due to an AE are presented.
|
Up to 22 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
28. juli 2021
Primær færdiggørelse (Faktiske)
8. maj 2025
Studieafslutning (Faktiske)
20. maj 2026
Datoer for studieregistrering
Først indsendt
29. juni 2021
Først indsendt, der opfyldte QC-kriterier
29. juni 2021
Først opslået (Faktiske)
2. juli 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer efter histologisk type
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Neoplasmer i hoved og hals
- Neoplasmer, kirtel og epitel
- Esophageale sygdomme
- Karcinom
- Neoplasmer, pladecelle
- Karcinom, pladecelle
- Esophageale neoplasmer
- Esophageal pladecellekarcinom
- Parkinson Disease 4, Autosomal Dominant Lewy Body
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Kulbrinter
- Cycloparaffiner
- Kulbrinter, alicyklisk
- Kulbrinter, cyklisk
- Terpenes
- Enzymer og coenzymer
- Uorganiske kemikalier
- Klorforbindelser
- Nitrogenforbindelser
- Koordinationskomplekser
- Taxoider
- Cyclodecanes
- Diterpenes
- Pyrimidiner
- Formyltetrahydrofolater
- Tetrahydrofolater
- Folinsyre
- Pterins
- Pteridiner
- Uracil
- Pyrimidinoner
- Coenzymer
- Platinforbindelser
- Oxaliplatin
- Fluorouracil
- Leucovorin
- Levoleucovorin
- Paclitaxel
- Cisplatin
- pembrolizumab
- lenvatinib
Andre undersøgelses-id-numre
- 7902-014
- MK-7902-014 (Anden identifikator: MSD)
- LEAP-014 (Anden identifikator: MSD)
- E7080-G000-320 (Anden identifikator: Eisai)
- U1111-1280-1020 (Registry Identifier: UTN)
- 2022-501342-29-00 (Registry Identifier: EU CT)
- 2020-001911-26 (EudraCT nummer)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .