Delstudie 06E: Paraplystudie av kombinasjonsterapier ved spiserørskreft (MK-3475-06E/KEYMAKER-U06)
En fase 1/2 open-label, paraplyplattformdesignstudie av etterforskningsmidler i kombinasjon med Pembrolizumab (MK-3475) med eller uten kjemoterapi hos deltakere med 1L lokalt avansert ikke-opererbar/metastatisk spiserørskreft: KEYMAKER-U06 delstudie 06E
Researchers are looking for new ways to treat esophageal squamous cell carcinoma (ESCC). ESCC is a type of cancer that starts in certain cells that line the esophagus. The esophagus is the tube that connects the throat to the stomach. This study will look at ESCC that is either locally advanced unresectable, which means it has spread into tissue near where it started and cannot be completely removed by surgery, or metastatic, which means it has spread to other body parts.
Available treatments for these types of ESCC include pembrolizumab and chemotherapy. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing.
Researchers want to learn about giving pembrolizumab and investigational agents, with or without chemotherapy to treat ESCC. Ifinatamab deruxtecan (I-DXd), is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.
The main goal of this study is to learn about the safety of investigational agents and pembrolizumab with or without chemotherapy and if people tolerate them. Researchers also want to learn how cancer responds (gets smaller or goes away) to the study treatments.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
The master protocol is MK-3475-U06.
Studietype
Registrering (Antatt)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-post: Trialsites@msd.com
Studiesteder
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São Paulo, Brasil, 01246-000
- Rekruttering
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1302)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 551138932000
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brasil, 59062-000
- Rekruttering
- Liga Norte Riograndense Contra o Cancer ( Site 1301)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +55 84 4009-5595
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 91010-004
- Rekruttering
- Hospital Nossa Senhora da Conceicao ( Site 1300)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +555133572092
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São Paulo
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São Paulo, São Paulo, Brasil, 03102-002
- Rekruttering
- IBCC - Instituto Brasileiro de Controle do Cancer ( Site 1303)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 551144500300
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Antofagasta, Chile, 1263521
- Rekruttering
- Bradford Hill Norte ( Site 1405)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +56442023631
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Los Lagos Region
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Port Montt, Los Lagos Region, Chile, 5500243
- Rekruttering
- Clínica Puerto Montt ( Site 1406)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +56652484800
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 7620002
- Rekruttering
- Clínica UC San Carlos de Apoquindo ( Site 1403)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +56223748924
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Santiago, Region M. de Santiago, Chile, 8420383
- Rekruttering
- Bradfordhill ( Site 1401)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +56220490970
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Santiago, Region M. de Santiago, Chile, 7560913
- Rekruttering
- Centro de Oncología de Precisión ( Site 1402)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +56972151681
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Santiago, Region M. de Santiago, Chile, 7500921
- Rekruttering
- Fundación Arturo López Pérez ( Site 1400)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +56224205098
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15232
- Rekruttering
- UPMC Hillman Cancer Center ( Site 1904)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 412-623-8974
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Paris, Frankrike, 75013
- Rekruttering
- Pitie Salpetriere University Hospital ( Site 9102)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +331 42 16 10 41
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Finistere
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Brest, Finistere, Frankrike, 29609
- Rekruttering
- C.H.R.U. de Brest - Hopital Cavale Blanche ( Site 9104)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 33298223428
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Nord
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Lille, Nord, Frankrike, 59037
- Rekruttering
- CHU Lille - Institut Coeur Poumon ( Site 9100)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33320445461
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Lombardy
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Milan, Lombardy, Italia, 20132
- Rekruttering
- Ospedale San Raffaele-Oncologia Medica ( Site 9201)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390226437615
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Veneto
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Padova, Veneto, Italia, 35128
- Rekruttering
- Istituto Oncologico Veneto IRCCS ( Site 9202)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 390498215910
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 464-8681
- Rekruttering
- Aichi Cancer Center ( Site 9702)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-52-762-6111
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Chiba
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Kashiwa, Chiba, Japan, 277-8577
- Rekruttering
- National Cancer Center Hospital East ( Site 9701)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-4-7133-1111
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Tokyo
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Chūō, Tokyo, Japan, 104-0045
- Rekruttering
- National Cancer Center Hospital ( Site 9700)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-3-3542-2511
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Anhui
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Hefei, Anhui, Kina, 230601
- Rekruttering
- The Second Affiliated Hospital of Anhui Medical University ( Site 9511)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0551-63839536
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 130021
- Rekruttering
- Beijing Cancer Hospital ( Site 9500)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: (010)88196317
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Fujian
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Xiamen, Fujian, Kina, 361003
- Rekruttering
- The First Affiliated Hospital of Xiamen University ( Site 9503)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0592-2139767
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Henan
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Zhengzhou, Henan, Kina, 450008
- Rekruttering
- Henan Cancer Hospital ( Site 9509)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0371-65587625
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Jiangsu
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Xuzhou, Jiangsu, Kina, 221000
- Rekruttering
- Xuzhou Central Hospital ( Site 9512)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 86051680812397
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Jiangxi
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Nanchang, Jiangxi, Kina, 330006
- Rekruttering
- The First Affiliated Hospital of Nanchang University ( Site 9505)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 86079188692201
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Oslo, Norge, 0379
- Rekruttering
- Oslo Universitetssykehus Radiumhospitalet ( Site 1501)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4723026600
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Central Singapore
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Singapore, Central Singapore, Singapore, 119074
- Rekruttering
- National University Hospital ( Site 9800)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +65 6908 2222
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Geneva, Sveits, 1211
- Rekruttering
- Hopitaux Universitaires de Geneve HUG. ( Site 1701)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +41 (0)22 372 95 77
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Kanton Graubünden
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Chur, Kanton Graubünden, Sveits, 7000
- Rekruttering
- Kantonsspital Graubuenden ( Site 1700)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +41 81 256 61 11
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Seoul, Sør -Korea, 05505
- Rekruttering
- Asan Medical Center ( Site 9901)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82230107179
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Seoul, Sør -Korea, 06351
- Rekruttering
- Samsung Medical Center ( Site 9900)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82234106518
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Kyonggi-do
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Goyang-si, Kyonggi-do, Sør -Korea, 10408
- Rekruttering
- National Cancer Center ( Site 9902)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82319201694
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Kaohsiung City, Taiwan, 83301
- Rekruttering
- Kaohsiung Chang Gung Memorial Hospital ( Site 1003)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +88677317123x3679
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Taichung, Taiwan, 40707
- Rekruttering
- China Medical University Hospital ( Site 1007)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 886-4-22052121
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Tainan, Taiwan, 704302
- Rekruttering
- National Cheng Kung University Hospital ( Site 1001)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +88662353535x4559
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Taipei, Taiwan, 100225
- Rekruttering
- National Taiwan University Hospital ( Site 1000)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +886223123456x67680
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Taipei, Taiwan, 11217
- Rekruttering
- Taipei Veterans General Hospital ( Site 1005)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +886228712121
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Taipei, Taiwan, 106
- Rekruttering
- National Taiwan University Cancer Center ( Site 1010)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 886223220322
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Taoyuan, Taiwan, 33305
- Rekruttering
- Chang Gung Memorial Hospital - Linkou Branch ( Site 1006)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +88633281200 #8825
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Kaohsiung
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Kaoshiung, Kaohsiung, Taiwan, 807
- Rekruttering
- Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 1009)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +8867-3121101#7451
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Bangkok
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Ratchathewi, Bangkok, Thailand, 10400
- Rekruttering
- Ramathibodi Hospital ( Site 1103)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +6622004029
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Changwat Songkhla
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Hat Yai, Changwat Songkhla, Thailand, 90110
- Rekruttering
- Songklanagarind hospital ( Site 1101)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +6674451469
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Brno-mesto
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Brno, Brno-mesto, Tsjekkia, 656 53
- Rekruttering
- Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 9000)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +420543136812
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Adana, Tyrkia (Türkiye), 01140
- Rekruttering
- Adana Medical Park Seyhan Hastanesi ( Site 9404)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +90444 44 84
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Ankara, Tyrkia (Türkiye), 06520
- Rekruttering
- Memorial Ankara Hastanesi ( Site 9406)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +905456177189
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Ankara, Tyrkia (Türkiye), 06230
- Rekruttering
- Hacettepe Universite Hastaneleri ( Site 9401)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +905333319240
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Ankara, Tyrkia (Türkiye), 06800
- Rekruttering
- Ankara Bilkent Şehir Hastanesi ( Site 9403)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +90 312 552 60 00
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Erzurum, Tyrkia (Türkiye), 25070
- Rekruttering
- Atatürk Üniversitesi ( Site 9405)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +905543701653
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Baden-Wurttemberg
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Heidelberg, Baden-Wurttemberg, Tyskland, 69120
- Rekruttering
- NCT-Department of Medical Oncology ( Site 1809)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +49 62215637784
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Free and Hanseatic City of Hamburg
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Erdgeschoss, Free and Hanseatic City of Hamburg, Tyskland, 22297
- Rekruttering
- HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 1807)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4940360352246
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North Rhine-Westphalia
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Düsseldorf, North Rhine-Westphalia, Tyskland, 40225
- Rekruttering
- Universitaetsklinikum Duesseldorf ( Site 1808)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +492118108751
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Saxony
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Dresden, Saxony, Tyskland, 01307
- Rekruttering
- Universitätsklinikum Carl Gustav Carus - Medical Oncology ( Site 1806)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +493514583016
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria
The main inclusion criteria include but are not limited to the following:
- Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic squamous cell carcinoma of the esophagus in first-line (1L) setting.
- Has measurable disease per RECIST 1.1 as assessed by the local site. investigator or designee/radiology assessment and verified by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
- Has had AEs due to previous anticancer therapies that have recovered to ≤Grade 1 or baseline. Endocrine-related AEs that are adequately treated with hormone replacement are elegible.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Has adequate organ function.
Exclusion Criteria
The main exclusion criteria include but are not limited to the following:
- Has had systemic anticancer therapy for locally advanced unresectable or metastatic esophageal cancer.
- Has tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula.
- Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
- Has clinically significant corneal disease, history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention.
- Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- Has inadequate cardiac function assessed as by a corrected QT interval by Fredericia (QTcF) value ≥470 msec.
- Has clinically significant cardiovascular disease within 6 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
- Has peripheral neuropathy ≥ Grade 2.
- Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has active autoimmune disease that has required systemic treatment in the past 2 years.
- Has had a history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), has a current diagnosis of ILD, or has clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out.
- Has active infection requiring systemic therapy.
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Pembrolizumab + Chemotherapy
Participants will receive 400 mg of pembrolizumab via intravenous (IV) infusion every six weeks (Q6W) on Day 1 of each 42-day cycle up to 18 cycles (up to approximately 2 years), and mFOLFOX6 chemotherapy: oxaliplatin 85 mg/m^2 via IV infusion every 2 weeks (Q2W), until progressive disease (PD) or toxicity; leucovorin 400 mg/m^2 OR levoleucovorin 200 mg/m^2 via IV infusion Q2W, until PD or toxicity; 5-fluorouracil (5-FU) 400 mg/m^2 bolus IV infusion followed by 2400 mg/m^2 continuous 46-48 hour IV infusion Q2W, until PD or toxicity. |
IV infusion IV infusion
Andre navn:
IV infusion IV infusion IV Infusion |
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Eksperimentell: Pembrolizumab + I-DXd
Participants will receive 200 mg of pembrolizumab via IV infusion Q3W on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years). Participants will also receive up to 12 mg/kg I-XDd Q3W via IV infusion, until PD or toxicity. |
IV infusion
Andre navn:
IV infusion
Andre navn:
Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid for Arms 2, 3, and 4, and H1 receptor antagonist, H2 receptor antagonist, acetaminophen, dexamethasone, and steroid mouthwash for Arm 5, administered per approved product label |
|
Eksperimentell: Pembrolizumab + I-DXd + 5-FU IV + Leucovorin or Levoleucovorin
Participants will receive 200 mg pembrolizumab via IV infusion Q3W on Day 1 of each 21-day cycle up to 35 cycles (up to approximately 2 years). Participants will also receive I-DXd up to 12 mg/kg via IV infusion Q3W, until PD or toxicity; 5-FU 400 mg/m^2 bolus IV infusion followed by 2400 mg/m^2 continuous 46-48 hour IV infusion Q2W, OR 2400 mg/m^2 continuous 46-48 hour IV infusion Q2W, until PD or toxicity; and leucovorin 400 mg/m^2 OR levoleucovorin 200 mg/m^2 via IV infusion Q2W, until PD or toxicity. |
IV infusion IV infusion
Andre navn:
IV infusion IV Infusion IV infusion
Andre navn:
Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid for Arms 2, 3, and 4, and H1 receptor antagonist, H2 receptor antagonist, acetaminophen, dexamethasone, and steroid mouthwash for Arm 5, administered per approved product label |
|
Eksperimentell: Pembrolizumab + I-DXd + 5-FU IV + Leucovorin or Levoleucovorin + Oxaliplatin
Participants will receive 200 mg of pembrolizumab via IV infusion Q3W on Day 1 of each 21-day cycle up to 35 cycles (up to approximately 2 years). Participants will also receive up to 12 mg/kg I-DXd via IV infusion q3w, until PD or toxicity; 5-FU 2400 mg/m^2 continuous 46-48 hour IV infusion Q2W, until PD or toxicity; 60mg/m^2 oxaliplatin via IV infusion Q2W, until PD or toxicity; and leucovorin 400 mg/m^2 OR levoleucovorin 200 mg/m^2 via IV infusion Q2W, until PD or toxicity. |
IV infusion IV infusion
Andre navn:
IV infusion IV infusion IV Infusion IV infusion
Andre navn:
Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid for Arms 2, 3, and 4, and H1 receptor antagonist, H2 receptor antagonist, acetaminophen, dexamethasone, and steroid mouthwash for Arm 5, administered per approved product label |
|
Eksperimentell: Pembrolizumab + Sacituzumab tirumotecan + 5-FU IV + Leucovorin or Levoleucovorin
Participants will receive 400 mg pembrolizumab via IV infusion Q6W on Day 1 of each 42-day cycle up to 18 cycles (up to approximately 2 years). Participants will also receive sacituzumab tirumotecan 4 mg/kg via IV infusion Days 1, 15, and 29 every 42-day cycle, until PD or toxicity; 5-FU 400 mg/m^2 bolus IV infusion followed by 2400 mg/m^2 continuous 46-48 hour IV infusion Q2W, OR 2400 mg/m^2 continuous 46-48 hour IV infusion Q2W, until PD or toxicity; and leucovorin 400 mg/m^2 OR levoleucovorin 200 mg/m^2 via IV infusion Q2W, until PD or toxicity. |
IV infusion IV infusion
Andre navn:
IV infusion IV Infusion Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid for Arms 2, 3, and 4, and H1 receptor antagonist, H2 receptor antagonist, acetaminophen, dexamethasone, and steroid mouthwash for Arm 5, administered per approved product label IV infusion
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase
Tidsramme: Up to approximately 28 days
|
Percentage of participants experiencing toxicities that are possibly, probably, or definitely related to study intervention; that meet pre-defined severity criteria; and result in a change in the given dose. |
Up to approximately 28 days
|
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Percentage of Participants who Experience an Adverse Event (AE)
Tidsramme: Up to approximately 77 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 percentage of participants who experience an AE will be reported. |
Up to approximately 77 months
|
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Objective Response Rate (ORR)
Tidsramme: Up to approximately 77 months
|
ORR is defined as a confirmed complete response (CR: the disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). The percentage of participants who experience CR or PR as assessed by BICR will be presented. |
Up to approximately 77 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Duration of Response (DOR)
Tidsramme: Up to approximately 77 months
|
For participants who demonstrate a confirmed 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, 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. DOR as assessed by BICR will be presented. |
Up to approximately 77 months
|
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Progression-Free Survival (PFS)
Tidsramme: Up to approximately 77 months
|
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. 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. PFS as assessed by BICR will be presented. |
Up to approximately 77 months
|
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Overall Survival (OS)
Tidsramme: Up to approximately 77 months
|
OS is defined as the time from allocation/randomization to death due to any cause. |
Up to approximately 77 months
|
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Disease Control Rate (DCR)
Tidsramme: Up to approximately 77 months
|
DCR is defined as a confirmed complete response (CR) or partial response (PR), or stable disease (SD) with at least 6 months PFS per RECIST 1.1 as assessed by BICR. |
Up to approximately 77 months
|
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Maximum Plasma Concentration (Cmax) of I-DXd
Tidsramme: At designated time points up to approximately 65 months
|
Cmax is defined as the peak level I-DXd reaches in the blood plasma. Blood samples collected predose and at multiple timepoints postdose will be used to determine the Cmax of I-DXd when co-administered with other investigational agents. |
At designated time points up to approximately 65 months
|
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Time to Maximum Plasma Concentration (Tmax) of I-DXd
Tidsramme: At designated time points up to approximately 65 months
|
Tmax is defined as the time it took I-DXd to reach its peak level in blood plasma. Blood samples collected predose and at designated timepoints postdose will be used to determine the Tmax of I-DXd when co-administered with other investigational agents. |
At designated time points up to approximately 65 months
|
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Area Under the Concentration-Time Curve from Time 0 to Last Measurable Plasma Concentration (AUClast) of I-DXd
Tidsramme: At designated time points up to approximately 65 months
|
AUClast is defined as the area under the concentration-time curve from time 0 to the last measurable concentration of I-DXd in the blood plasma. Blood samples collected at predose and at designated timepoints postdose will be used to determine the AUClast of I-DXd in combination with other agents. |
At designated time points up to approximately 65 months
|
|
Area Under the Concentration-Time Curve from Time 0 to the End of the Dosing Period (AUCtau) of I-DXd
Tidsramme: At designated time points up to approximately 65 months
|
AUCtau is defined as the area under the concentration-time curve from time zero to the end of the dosing period. Blood samples collected at predose and at designated timepoints postdose will be used to determine the AUCtau of I-DXd in combination with other agents. |
At designated time points up to approximately 65 months
|
|
The Percentage of Participants with Antidrug Antibodies (ADA) Against I-DXd
Tidsramme: Up to approximately 65 months
|
Blood samples collected at designated timepoints will be used to determine the ADA response to I-DXd. The percentage of participants with ADA will be reported. |
Up to approximately 65 months
|
|
The Percentage of Participants with Treatment-Emergent ADA Against I-DXd
Tidsramme: Up to approximately 65 months
|
Blood samples collected at designated timepoints will be used to determine the treatment-emergent ADA response to I-DXd. The percentage of participants who have treatment-emergent I-DXd ADA will be reported. |
Up to approximately 65 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer etter histologisk type
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Neoplasmer i hode og nakke
- Neoplasmer, kjertel og epitel
- Esophageal sykdommer
- Karsinom
- Neoplasmer, plateepitelceller
- Karsinom, plateepitel
- Neoplasmer i spiserøret
- Esophageal plateepitelkarsinom
- Organiske kjemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Enzymer og koenzymer
- Koordinasjonskomplekser
- Pyrimidiner
- Formyltetrahydrofolater
- Tetrahydrofolater
- Folsyre
- Pteriner
- Pteridiner
- Uracil
- Pyrimidinoner
- Koenzymer
- Oksaliplatin
- Fluorouracil
- Leucovorin
- Levoleucovorin
- pembrolizumab
Andre studie-ID-numre
- 3475-06E
- MK-3475-06E (Annen identifikator: MSD)
- U1111-1307-6484 (Registeridentifikator: UTN)
- jRCT2041240166 (Registeridentifikator: Japan Registry of Clinical Trials (jRCT))
- 2024-514273-22-00 (Registeridentifikator: EU CT)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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