Subestudo 06C: Um estudo de sacituzumabe tirumotecano (MK-2870) com pembrolizumabe (MK-3475) e quimioterapia em participantes com adenocarcinoma gastroesofágico metastático/irressecável localmente avançado de primeira linha (MK-3475-06C/KEYMAKER-U06)
Um estudo de design de plataforma guarda-chuva de fase 1/2 aberto de MK-2870 com pembrolizumabe (MK-3475) e quimioterapia em participantes com 1L de adenocarcinoma gastroesofágico localmente avançado irressecável/metastático (adenocarcinoma gástrico, adenocarcinoma de junção gastroesofágica e adenocarcinoma de esôfago): Subestudo 06C
This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluate the safety and tolerability of investigational agents with pembrolizumab and fluoropyrimidine chemotherapy for the first-line (1L) treatment of participants with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma.
This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for investigational agents in combination with chemotherapy and immunotherapy. There is no formal hypothesis in this study.
Visão geral do estudo
Status
Condições
Descrição detalhada
The master protocol is MK-3475-U06.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Toll Free Number
- Número de telefone: 1-888-577-8839
- E-mail: Trialsites@msd.com
Locais de estudo
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Baden-Wurttemberg
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Heidelberg, Baden-Wurttemberg, Alemanha, 69120
- Recrutamento
- NCT-Department of Medical Oncology ( Site 6809)
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Contato:
- Study Coordinator
- Número de telefone: +49 62215637784
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Free and Hanseatic City of Hamburg
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Erdgeschoss, Free and Hanseatic City of Hamburg, Alemanha, 22297
- Recrutamento
- HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 6807)
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Contato:
- Study Coordinator
- Número de telefone: + 4940360352246
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North Rhine-Westphalia
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Düsseldorf, North Rhine-Westphalia, Alemanha, 40225
- Concluído
- Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 6802)
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São Paulo, Brasil, 03102-006
- Recrutamento
- IBCC - Instituto Brasileiro de Controle do Câncer ( Site 6304)
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Contato:
- Study Coordinator
- Número de telefone: 551144500300
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São Paulo, Brasil, 01246-000
- Recrutamento
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 6300)
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Contato:
- Study Coordinator
- Número de telefone: 551138932000
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brasil, 59062-000
- Recrutamento
- Liga Norte Riograndense Contra o Câncer ( Site 6303)
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Contato:
- Study Coordinator
- Número de telefone: +558440095595
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 91350-200
- Recrutamento
- Hospital Nossa Senhora da Conceição ( Site 6301)
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Contato:
- Study Coordinator
- Número de telefone: +5551993590437
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Antofagasta, Chile, 1263521
- Recrutamento
- Bradford Hill Norte ( Site 6407)
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Contato:
- Study Coordinator
- Número de telefone: 56442023631
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Los Lagos Region
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Port Montt, Los Lagos Region, Chile, 5500243
- Recrutamento
- Clínica Puerto Montt ( Site 6409)
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Contato:
- Study Coordinator
- Número de telefone: 56961687093
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Maule Region
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Talca, Maule Region, Chile, 3481349
- Concluído
- Centro de Investigación del Maule ( Site 6408)
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 7500921
- Recrutamento
- FALP-UIDO ( Site 6400)
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Contato:
- Study Coordinator
- Número de telefone: 56224205098
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Santiago, Region M. de Santiago, Chile, 7560908
- Recrutamento
- Centro de Oncología de Precisión-Oncology ( Site 6404)
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Contato:
- Study Coordinator
- Número de telefone: 56225189885
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Santiago, Region M. de Santiago, Chile, 7620002
- Recrutamento
- Clínica UC San Carlos de Apoquindo ( Site 6405)
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Contato:
- Study Coordinator
- Número de telefone: 56934271024
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Santiago, Region M. de Santiago, Chile, 8420383
- Recrutamento
- Bradfordhill-Clinical Area ( Site 6401)
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Contato:
- Study Coordinator
- Número de telefone: 56229490970
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100142
- Recrutamento
- Beijing Cancer hospital-Digestive Oncology ( Site 5500)
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Contato:
- Study Coordinator
- Número de telefone: (010)88196317
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Fujian
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Fuzhou, Fujian, China, 350025
- Recrutamento
- The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 5501)
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Contato:
- Study Coordinator
- Número de telefone: 0591-22859606
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Xiamen, Fujian, China, 361003
- Recrutamento
- The First Affiliated hospital of Xiamen University ( Site 5503)
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Contato:
- Study Coordinator
- Número de telefone: 0592-2139767
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Henan
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Zhengzhou, Henan, China, 450008
- Recrutamento
- Henan Cancer Hospital ( Site 5504)
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Contato:
- Study Coordinator
- Número de telefone: 400-0371-818
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Jiangxi
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Nanchang, Jiangxi, China, 330000
- Recrutamento
- The First Affiliated Hospital of Nanchang University ( Site 5514)
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Contato:
- Study Coordinator
- Número de telefone: 0791-86427234
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200032
- Ativo, não recrutando
- Fudan University Shanghai Cancer Center ( Site 5513)
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Xinjiang
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Ürümqi, Xinjiang, China, 841100
- Ativo, não recrutando
- Xinjiang Medical University Cancer Hospital - Urumqi ( Site 5506)
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Zhejiang
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Hangzhou, Zhejiang, China, 310016
- Recrutamento
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5510)
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Contato:
- Study Coordinator
- Número de telefone: 0571 8609 0073
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Seoul, Coréia do Sul, 05505
- Recrutamento
- Asan Medical Center-Department of Oncology ( Site 5901)
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Contato:
- Study Coordinator
- Número de telefone: +82230103217
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Seoul, Coréia do Sul, 06351
- Recrutamento
- Samsung Medical Center-Division of Hematology/Oncology ( Site 5900)
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Contato:
- Study Coordinator
- Número de telefone: 82234101795
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Arizona
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Tucson, Arizona, Estados Unidos, 85719
- Recrutamento
- University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 6927)
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Contato:
- Study Coordinator
- Número de telefone: 520-621-2449
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California
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Los Angeles, California, Estados Unidos, 90404
- Recrutamento
- UCLA Hematology/Oncology - Santa Monica ( Site 6905)
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Contato:
- Study Coordinator
- Número de telefone: 310-570-1453
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- Concluído
- Norton Hospital-Norton Cancer Institute - Downtown ( Site 6900)
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Michigan
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Grand Rapids, Michigan, Estados Unidos, 49503
- Recrutamento
- The Cancer and Hematology Centers ( Site 6912)
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Contato:
- Study Coordinator
- Número de telefone: 616-975-3065
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New York
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East Syracuse, New York, Estados Unidos, 13057
- Recrutamento
- Hematology-Oncology Associates of Central NY, P.C. ( Site 6925)
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Contato:
- Study Coordinator
- Número de telefone: 315-472-7504
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New York, New York, Estados Unidos, 10032
- Concluído
- Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 6907)
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15232
- Recrutamento
- UPMC Hillman Cancer Center-UPMC ( Site 6904)
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Contato:
- Study Coordinator
- Número de telefone: 816-898-9413
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Texas
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Houston, Texas, Estados Unidos, 77030
- Recrutamento
- University of Texas MD Anderson Cancer Center ( Site 6920)
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Contato:
- Study Coordinator
- Número de telefone: 833-589-0868
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Finistere
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Brest, Finistere, França, 29200
- Recrutamento
- CHU-BREST Cavale Blanche ( Site 5104)
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Contato:
- Study Coordinator
- Número de telefone: 33298223428
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Nord
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Lille, Nord, França, 59037
- Recrutamento
- CIC. ( Site 5100)
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Contato:
- Study Coordinator
- Número de telefone: +33320445461
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Île-de-France Region
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Paris, Île-de-France Region, França, 75013
- Recrutamento
- Pitie Salpetriere University Hospital-Hepato-Gastro-Enterology ( Site 5102)
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Contato:
- Study Coordinator
- Número de telefone: +331 42 16 10 41
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Milan, Itália, 20132
- Recrutamento
- Ospedale San Raffaele-Oncologia Medica ( Site 5202)
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Contato:
- Study Coordinator
- Número de telefone: +390226437615
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Emilia-Romagna
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Meldola, Emilia-Romagna, Itália, 47014
- Recrutamento
- IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 5207)
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Contato:
- Study Coordinator
- Número de telefone: 0543739100
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Lombardy
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Milan, Lombardy, Itália, 20133
- Recrutamento
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 5200)
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Contato:
- Study Coordinator
- Número de telefone: 0223903807
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Tuscany
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Pisa, Tuscany, Itália, 56126
- Recrutamento
- Azienda Ospedaliero Universitaria Pisana ( Site 5206)
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Contato:
- Study Coordinator
- Número de telefone: 050992454
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Oslo, Noruega, 0379
- Recrutamento
- Oslo universitetssykehus, Radiumhospitalet ( Site 6501)
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Contato:
- Study Coordinator
- Número de telefone: 4723026600
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Canton of Geneva
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Geneva, Canton of Geneva, Suíça, 1211
- Recrutamento
- Hôpitaux Universitaires de Genève (HUG) ( Site 6701)
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Contato:
- Study Coordinator
- Número de telefone: +41 22 372 29 01
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Kanton Graubünden
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Chur, Kanton Graubünden, Suíça, 7000
- Recrutamento
- Kantonsspital Graubünden-Medizin ( Site 6700)
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Contato:
- Study Coordinator
- Número de telefone: +41 81 256 61 11
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Bangkok
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Bangkoknoi, Bangkok, Tailândia, 10700
- Recrutamento
- Faculty of Medicine Siriraj Hospital ( Site 6102)
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Contato:
- Study Coordinator
- Número de telefone: +6624194489
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Pathumwan, Bangkok, Tailândia, 10330
- Recrutamento
- Chulalongkorn Hospital ( Site 6104)
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Contato:
- Study Coordinator
- Número de telefone: 022564533
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Ratchathewi, Bangkok, Tailândia, 10400
- Recrutamento
- Ramathibodi Hospital ( Site 6103)
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Contato:
- Study Coordinator
- Número de telefone: 022011671
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Changwat Songkhla
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Hat Yai, Changwat Songkhla, Tailândia, 90110
- Recrutamento
- Songklanagarind hospital ( Site 6101)
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Contato:
- Study Coordinator
- Número de telefone: +6674451469
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Taichung, Taiwan, 404
- Recrutamento
- China Medical University Hospital ( Site 6007)
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Contato:
- Study Coordinator
- Número de telefone: 886422052121x15057
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Tainan, Taiwan, 704
- Recrutamento
- National Cheng Kung University Hospital ( Site 6001)
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Contato:
- Study Coordinator
- Número de telefone: +88662353535x4559
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Taipei, Taiwan, 10048
- Recrutamento
- National Taiwan University Hospital-Oncology ( Site 6000)
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Contato:
- Study Coordinator
- Número de telefone: +88623123456x267852
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Taipei, Taiwan, 112
- Recrutamento
- Taipei Veterans General Hospital ( Site 6005)
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Contato:
- Study Coordinator
- Número de telefone: +88628717270x131
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Has histologically and/or cytologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic first-line (1L) gastroesophageal adenocarcinoma
- Is not expected to require tumor resection during the treatment course
- Tumor tissue must be confirmed as negative for human epidermal growth factor receptor 2 (HER2) expression as classified by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines
- Core/excisional biopsy of a tumor lesion not previously irradiated has been provided
- Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
- Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible
- Has adequate organ function
- Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by the local site investigator/radiology assessment and verified by blinded independent central review (BICR)
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the first dose of study intervention
- Has a life expectancy of at least 6 months
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation/randomization
- Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has squamous cell or undifferentiated gastroesophageal cancer.
- Has had previous therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ)/esophageal adenocarcinoma
- Has experienced weight loss >20% over 3 months before the first dose of study intervention
- Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- Has Grade ≥2 peripheral neuropathy
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within 6 months preceding study intervention
- Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment
- Has history of human immunodeficiency virus (HIV) infection with Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has received prior treatment with a trophoblast antigen 2 (TROP2)-targeted or anti-human epidermal growth factor receptor 3 (HER3) targeted agents
- Has received prior treatment with a topoisomerase I inhibitor-based antibody-drug conjugate (ADC) and/or a topoisomerase I inhibitor-based chemotherapy
- Has received prior systemic anticancer therapy within 4 weeks before the first dose of study intervention
- Has received prior therapy with an anti-Programmed Cell Death Protein 1 (PD-1), anti-Programmed Cell Death-Ligand 1 (PD-L1), anti-Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (TCR)
- 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
- Has received a strong inducer/inhibitor of CYP3A4 that cannot be discontinued
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy 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 Severe hypersensitivity (≥Grade 3) to pembrolizumab, sacituzumab tirumotecan, patritumab deruxtecan, or other biologic therapy, chemotherapy (ie, oxaliplatin, fluorouracil, capecitabine), leucovorin, levoleucovorin, or any of their excipients
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening
- Has an active infection requiring systemic therapy
- Has concurrent active hepatitis B (defined as Hepatitis B surface antigen [HBsAg] positive and/or detectable HBV DNA) and hepatitis C virus (defined as anti-hepatitis C virus [HCV] Ab positive and detectable HCV ribonucleic acid [RNA] infection or a known history of hepatitis B and/or C infection
- Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study
- Has gastrointestinal (GI) obstruction, poor oral intake, or difficulty in taking oral medication
- Has poorly controlled diarrhea
- Has had a major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention
- Has history of allogeneic tissue/solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Pembrolizumab plus Chemotherapy
Participants will receive pembrolizumab 400 mg via intravenous (IV) injection on day 1 of every 6 week cycle (Q6W) for up to 18 cycles (up to ~2 years) AND investigator's choice of CAPOX chemotherapy (capecitabine 1000 mg/m^2 orally twice daily for 14 days every 3 weeks (Q3W) and oxaliplatin 130 mg/m^2 via IV infusion Q3W) OR mFOLFOX6 chemotherapy (oxaliplatin 85 mg/m^2 via IV infusion Q3W; 5-Fluorouracil (5-FU) 400 mg/^2 via bolus IV plus 2400 mg/m^2 continuous IV once every 2 weeks (Q2W); and leucovorin 400 mg/m^2 via IV infusion Q2W OR levoleucovorin 200 mg/m^2 Q2W). |
Administered via intravenous (IV) infusion.
Outros nomes:
Administered via oral tablet.
Outros nomes:
Administered via IV infusion.
Outros nomes:
Administered via IV infusion.
Outros nomes:
Administered via IV infusion
Outros nomes:
Administered via IV infusion |
|
Experimental: Pembrolizumab plus Sacituzumab Tirumotecan plus Chemotherapy
Participants will receive sacituzumab tirumotecan via IV infusion on Days 1, 15, and 29 Q6W until discontinuation, pembrolizumab 400 mg via IV injection on day 1 Q6W for up to 18 cycles (up to ~2 years) AND investigator's choice of capecitabine 1000 mg/m^2 orally twice daily for 14 days Q3W OR 5-FU 2400 mg/m^2 IV once Q2W AND leucovorin 400 mg/m^2 via IV infusion Q2W OR levoleucovorin 200 mg/m^2 Q2W. |
Administered via intravenous (IV) infusion.
Outros nomes:
Administered via oral tablet.
Outros nomes:
Administered via IV infusion.
Outros nomes:
Administered via IV infusion.
Outros nomes:
Administered via IV infusion
Outros nomes:
Administered via IV infusion.
Outros nomes:
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Experimental: Pembrolizumab plus Patritumab Deruxtecan plus Chemotherapy
Participants will receive patritumab deruxtecan via IV infusion on Days 1 and 22 Q6W until discontinuation, pembrolizumab 400 mg via IV injection on day 1 Q6W for up to 18 cycles (up to ~2 years) AND investigator's choice of capecitabine 1000 mg/m^2 orally twice daily for 14 days Q3W OR 5-FU 2400 mg/m^2 IV once Q2W AND leucovorin 400 mg/m^2 via IV infusion Q2W OR levoleucovorin 200 mg/m^2 Q2W. |
Administered via intravenous (IV) infusion.
Outros nomes:
Administered via oral tablet.
Outros nomes:
Administered via IV infusion.
Outros nomes:
Administered via IV infusion.
Outros nomes:
Administered via IV infusion
Outros nomes:
Administered via IV infusion
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
Prazo: Up to approximately 28 days
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DLTs are defined as any treatment-emergent adverse events (TEAEs) not attributable to disease or disease-related processes that occur during the DLT evaluation period and are a Grade 3 or higher according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0. The percentage of participants who experience at least one DLT will be reported. |
Up to approximately 28 days
|
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Safety Lead-in Phase: Number of Participants Who Experienced an Adverse Event (AE)
Prazo: Up to approximately 28 days
|
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. |
Up to approximately 28 days
|
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Safety Lead-in Phase: Number of Participants Who Discontinued Study Intervention Due to an AE
Prazo: Up to approximately 28 days
|
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. |
Up to approximately 28 days
|
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Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Prazo: Up to approximately 28 months
|
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented. |
Up to approximately 28 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR
Prazo: Up to approximately 55 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 55 months
|
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Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
Prazo: Up to approximately 55 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 55 months
|
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Overall Survival (OS)
Prazo: Up to approximately 55 months
|
OS is defined as the time from randomization to the date of death from any cause. |
Up to approximately 55 months
|
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Number of Participants Who Experience an Adverse Event (AE)
Prazo: Up to approximately 55 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. |
Up to approximately 55 months
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
Prazo: Up to approximately 55 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. |
Up to approximately 55 months
|
|
Incidence of Antidrug Antibodies (ADA) to investigational agents - (sacituzumab tirumotecan (sac-TMT, MK-2870) and patritumab deruxtecan (HER3-DXd))
Prazo: At designated timepoints up to approximately 55 months
|
Blood samples collected at designated timepoints will be used to determine the ADA response to investigational agents. The incidence of ADAs over time will be presented. |
At designated timepoints up to approximately 55 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Medical Director, Merck Sharp & Dohme LLC
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Neoplasias por local
- Neoplasias
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Neoplasias de Cabeça e Pescoço
- Doenças Esofágicas
- Neoplasias Esofágicas
- Doença de Parkinson 4, Corpo Autossômico Dominante de Lewy
- Produtos químicos orgânicos
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Compostos heterocíclicos, 2 anel
- Compostos heterocíclicos, anel fundido
- Ácidos nucleicos, nucleotídeos e nucleosídeos
- Enzimas e coenzimas
- Complexos de coordenação
- Desoxicitidina
- Citidina
- Nucleosídeos de pirimidina
- Pirimidinas
- Nucleosídeos
- Formiltetra -hidrofolatos
- Tetra -hidrofolatos
- Ácido fólico
- Pterins
- Pteridinas
- Uracil
- Pirimidinonas
- Coenzimas
- Desoxirribonucleosídeos
- Capecitabina
- Oxaliplatina
- Fluorouracila
- Leucovorina
- Levoleucovorina
- Pembrolizumab
- Patritumab Deruxtecan
Outros números de identificação do estudo
- 3475-06C
- MK-3475-06C (Outro identificador: MSD)
- KEYMAKER-06C (Outro identificador: MSD)
- U1111-1299-8084 (Identificador de registro: UTN)
- 2023-509307-33-00 (Identificador de registro: EU CT)
- 2023 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informações sobre medicamentos e dispositivos, documentos de estudo
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