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Subestudo 06E: Estudo guarda-chuva de terapias combinadas em câncer de esôfago (MK-3475-06E/KEYMAKER-U06)

23 de outubro de 2026 atualizado por: Merck Sharp & Dohme LLC

Um estudo de fase 1/2 aberto, plataforma guarda-chuva de agentes investigacionais em combinação com pembrolizumabe (MK-3475) com ou sem quimioterapia em participantes com 1L de câncer de esôfago metastático/irressecável localmente avançado: KEYMAKER-U06 Subestudo 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

The master protocol is MK-3475-U06.

Tipo de estudo

Intervencional

Inscrição (Estimado)

298

Estágio

  • Fase 2
  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Alemanha
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Alemanha, 69120
        • Recrutamento
        • NCT-Department of Medical Oncology ( Site 1809)
        • Contato:
          • Study Coordinator
          • Número de telefone: +49 62215637784
    • Free and Hanseatic City of Hamburg
      • Erdgeschoss, Free and Hanseatic City of Hamburg, Alemanha, 22297
        • Recrutamento
        • HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 1807)
        • Contato:
          • Study Coordinator
          • Número de telefone: +4940360352246
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Alemanha, 40225
        • Recrutamento
        • Universitaetsklinikum Duesseldorf ( Site 1808)
        • Contato:
          • Study Coordinator
          • Número de telefone: +492118108751
    • Saxony
      • Dresden, Saxony, Alemanha, 01307
        • Recrutamento
        • Universitätsklinikum Carl Gustav Carus - Medical Oncology ( Site 1806)
        • Contato:
          • Study Coordinator
          • Número de telefone: +493514583016
  • Brasil
      • São Paulo, Brasil, 01246-000
        • Recrutamento
        • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1302)
        • Contato:
          • Study Coordinator
          • Número de telefone: 551138932000
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brasil, 59062-000
        • Recrutamento
        • Liga Norte Riograndense Contra o Cancer ( Site 1301)
        • Contato:
          • Study Coordinator
          • Número de telefone: +55 84 4009-5595
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasil, 91010-004
        • Recrutamento
        • Hospital Nossa Senhora da Conceicao ( Site 1300)
        • Contato:
          • Study Coordinator
          • Número de telefone: +555133572092
    • São Paulo
      • São Paulo, São Paulo, Brasil, 03102-002
        • Recrutamento
        • IBCC - Instituto Brasileiro de Controle do Cancer ( Site 1303)
        • Contato:
          • Study Coordinator
          • Número de telefone: 551144500300
  • Chile
      • Antofagasta, Chile, 1263521
        • Recrutamento
        • Bradford Hill Norte ( Site 1405)
        • Contato:
          • Study Coordinator
          • Número de telefone: +56442023631
    • Los Lagos Region
      • Port Montt, Los Lagos Region, Chile, 5500243
        • Recrutamento
        • Clínica Puerto Montt ( Site 1406)
        • Contato:
          • Study Coordinator
          • Número de telefone: +56652484800
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7620002
        • Recrutamento
        • Clínica UC San Carlos de Apoquindo ( Site 1403)
        • Contato:
          • Study Coordinator
          • Número de telefone: +56223748924
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recrutamento
        • Bradfordhill ( Site 1401)
        • Contato:
          • Study Coordinator
          • Número de telefone: +56220490970
      • Santiago, Region M. de Santiago, Chile, 7560913
        • Recrutamento
        • Centro de Oncología de Precisión ( Site 1402)
        • Contato:
          • Study Coordinator
          • Número de telefone: +56972151681
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recrutamento
        • Fundación Arturo López Pérez ( Site 1400)
        • Contato:
          • Study Coordinator
          • Número de telefone: +56224205098
  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • Recrutamento
        • The Second Affiliated Hospital of Anhui Medical University ( Site 9511)
        • Contato:
          • Study Coordinator
          • Número de telefone: 0551-63839536
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 130021
        • Recrutamento
        • Beijing Cancer Hospital ( Site 9500)
        • Contato:
          • Study Coordinator
          • Número de telefone: (010)88196317
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Recrutamento
        • The First Affiliated Hospital of Xiamen University ( Site 9503)
        • Contato:
          • Study Coordinator
          • Número de telefone: 0592-2139767
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recrutamento
        • Henan Cancer Hospital ( Site 9509)
        • Contato:
          • Study Coordinator
          • Número de telefone: 0371-65587625
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Recrutamento
        • Xuzhou Central Hospital ( Site 9512)
        • Contato:
          • Study Coordinator
          • Número de telefone: 86051680812397
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recrutamento
        • The First Affiliated Hospital of Nanchang University ( Site 9505)
        • Contato:
          • Study Coordinator
          • Número de telefone: 86079188692201
  • Cingapura
    • Central Singapore
      • Singapore, Central Singapore, Cingapura, 119074
        • Recrutamento
        • National University Hospital ( Site 9800)
        • Contato:
          • Study Coordinator
          • Número de telefone: +65 6908 2222
  • Coréia do Sul
      • Seoul, Coréia do Sul, 05505
        • Recrutamento
        • Asan Medical Center ( Site 9901)
        • Contato:
          • Study Coordinator
          • Número de telefone: +82230107179
      • Seoul, Coréia do Sul, 06351
        • Recrutamento
        • Samsung Medical Center ( Site 9900)
        • Contato:
          • Study Coordinator
          • Número de telefone: +82234106518
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, Coréia do Sul, 10408
        • Recrutamento
        • National Cancer Center ( Site 9902)
        • Contato:
          • Study Coordinator
          • Número de telefone: +82319201694
  • Estados Unidos
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15232
        • Recrutamento
        • UPMC Hillman Cancer Center ( Site 1904)
        • Contato:
          • Study Coordinator
          • Número de telefone: 412-623-8974
  • França
      • Paris, França, 75013
        • Recrutamento
        • Pitie Salpetriere University Hospital ( Site 9102)
        • Contato:
          • Study Coordinator
          • Número de telefone: +331 42 16 10 41
    • Finistere
      • Brest, Finistere, França, 29609
        • Recrutamento
        • C.H.R.U. de Brest - Hopital Cavale Blanche ( Site 9104)
        • Contato:
          • Study Coordinator
          • Número de telefone: 33298223428
    • Nord
      • Lille, Nord, França, 59037
        • Recrutamento
        • CHU Lille - Institut Coeur Poumon ( Site 9100)
        • Contato:
          • Study Coordinator
          • Número de telefone: +33320445461
  • Itália
    • Lombardy
      • Milan, Lombardy, Itália, 20132
        • Recrutamento
        • Ospedale San Raffaele-Oncologia Medica ( Site 9201)
        • Contato:
          • Study Coordinator
          • Número de telefone: +390226437615
    • Veneto
      • Padova, Veneto, Itália, 35128
        • Recrutamento
        • Istituto Oncologico Veneto IRCCS ( Site 9202)
        • Contato:
          • Study Coordinator
          • Número de telefone: 390498215910
  • Japão
    • Aichi-ken
      • Nagoya, Aichi-ken, Japão, 464-8681
        • Recrutamento
        • Aichi Cancer Center ( Site 9702)
        • Contato:
          • Study Coordinator
          • Número de telefone: +81-52-762-6111
    • Chiba
      • Kashiwa, Chiba, Japão, 277-8577
        • Recrutamento
        • National Cancer Center Hospital East ( Site 9701)
        • Contato:
          • Study Coordinator
          • Número de telefone: +81-4-7133-1111
    • Tokyo
      • Chūō, Tokyo, Japão, 104-0045
        • Recrutamento
        • National Cancer Center Hospital ( Site 9700)
        • Contato:
          • Study Coordinator
          • Número de telefone: +81-3-3542-2511
  • Noruega
      • Oslo, Noruega, 0379
        • Recrutamento
        • Oslo Universitetssykehus Radiumhospitalet ( Site 1501)
        • Contato:
          • Study Coordinator
          • Número de telefone: +4723026600
  • Suíça
      • Geneva, Suíça, 1211
        • Recrutamento
        • Hopitaux Universitaires de Geneve HUG. ( Site 1701)
        • Contato:
          • Study Coordinator
          • Número de telefone: +41 (0)22 372 95 77
    • Kanton Graubünden
      • Chur, Kanton Graubünden, Suíça, 7000
        • Recrutamento
        • Kantonsspital Graubuenden ( Site 1700)
        • Contato:
          • Study Coordinator
          • Número de telefone: +41 81 256 61 11
  • Tailândia
    • Bangkok
      • Ratchathewi, Bangkok, Tailândia, 10400
        • Recrutamento
        • Ramathibodi Hospital ( Site 1103)
        • Contato:
          • Study Coordinator
          • Número de telefone: +6622004029
    • Changwat Songkhla
      • Hat Yai, Changwat Songkhla, Tailândia, 90110
        • Recrutamento
        • Songklanagarind hospital ( Site 1101)
        • Contato:
          • Study Coordinator
          • Número de telefone: +6674451469
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Recrutamento
        • Kaohsiung Chang Gung Memorial Hospital ( Site 1003)
        • Contato:
          • Study Coordinator
          • Número de telefone: +88677317123x3679
      • Taichung, Taiwan, 40707
        • Recrutamento
        • China Medical University Hospital ( Site 1007)
        • Contato:
          • Study Coordinator
          • Número de telefone: 886-4-22052121
      • Tainan, Taiwan, 704302
        • Recrutamento
        • National Cheng Kung University Hospital ( Site 1001)
        • Contato:
          • Study Coordinator
          • Número de telefone: +88662353535x4559
      • Taipei, Taiwan, 100225
        • Recrutamento
        • National Taiwan University Hospital ( Site 1000)
        • Contato:
          • Study Coordinator
          • Número de telefone: +886223123456x67680
      • Taipei, Taiwan, 11217
        • Recrutamento
        • Taipei Veterans General Hospital ( Site 1005)
        • Contato:
          • Study Coordinator
          • Número de telefone: +886228712121
      • Taipei, Taiwan, 106
        • Recrutamento
        • National Taiwan University Cancer Center ( Site 1010)
        • Contato:
          • Study Coordinator
          • Número de telefone: 886223220322
      • Taoyuan, Taiwan, 33305
        • Recrutamento
        • Chang Gung Memorial Hospital - Linkou Branch ( Site 1006)
        • Contato:
          • Study Coordinator
          • Número de telefone: +88633281200 #8825
    • Kaohsiung
      • Kaoshiung, Kaohsiung, Taiwan, 807
        • Recrutamento
        • Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 1009)
        • Contato:
          • Study Coordinator
          • Número de telefone: +8867-3121101#7451
  • Tcheca
    • Brno-mesto
      • Brno, Brno-mesto, Tcheca, 656 53
        • Recrutamento
        • Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 9000)
        • Contato:
          • Study Coordinator
          • Número de telefone: +420543136812
  • Turquia (Türkiye)
      • Adana, Turquia (Türkiye), 01140
        • Recrutamento
        • Adana Medical Park Seyhan Hastanesi ( Site 9404)
        • Contato:
          • Study Coordinator
          • Número de telefone: +90444 44 84
      • Ankara, Turquia (Türkiye), 06520
        • Recrutamento
        • Memorial Ankara Hastanesi ( Site 9406)
        • Contato:
          • Study Coordinator
          • Número de telefone: +905456177189
      • Ankara, Turquia (Türkiye), 06230
        • Recrutamento
        • Hacettepe Universite Hastaneleri ( Site 9401)
        • Contato:
          • Study Coordinator
          • Número de telefone: +905333319240
      • Ankara, Turquia (Türkiye), 06800
        • Recrutamento
        • Ankara Bilkent Şehir Hastanesi ( Site 9403)
        • Contato:
          • Study Coordinator
          • Número de telefone: +90 312 552 60 00
      • Erzurum, Turquia (Türkiye), 25070
        • Recrutamento
        • Atatürk Üniversitesi ( Site 9405)
        • Contato:
          • Study Coordinator
          • Número de telefone: +905543701653

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

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
Comparador Ativo: 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.
Medicamento: Leucovorin

IV infusion

Biológico: Pembrolizumab

IV infusion

Outros nomes:
  • MK-3475
  • KEYTRUDA®
Medicamento: Oxaliplatin

IV infusion

Medicamento: Levoleucovorin

IV infusion

Medicamento: 5-Fluorouracil (5-FU)

IV Infusion
Experimental: 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.
Biológico: Pembrolizumab

IV infusion

Outros nomes:
  • MK-3475
  • KEYTRUDA®
Biológico: I-DXd

IV infusion

Outros nomes:
  • DS-7300a
  • MK-2400
  • Ifinatamabe deruxtecano
Medicamento: Rescue Medication

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
Experimental: 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.
Medicamento: Leucovorin

IV infusion

Biológico: Pembrolizumab

IV infusion

Outros nomes:
  • MK-3475
  • KEYTRUDA®
Medicamento: Levoleucovorin

IV infusion

Medicamento: 5-Fluorouracil (5-FU)

IV Infusion

Biológico: I-DXd

IV infusion

Outros nomes:
  • DS-7300a
  • MK-2400
  • Ifinatamabe deruxtecano
Medicamento: Rescue Medication

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
Experimental: 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.
Medicamento: Leucovorin

IV infusion

Biológico: Pembrolizumab

IV infusion

Outros nomes:
  • MK-3475
  • KEYTRUDA®
Medicamento: Oxaliplatin

IV infusion

Medicamento: Levoleucovorin

IV infusion

Medicamento: 5-Fluorouracil (5-FU)

IV Infusion

Biológico: I-DXd

IV infusion

Outros nomes:
  • DS-7300a
  • MK-2400
  • Ifinatamabe deruxtecano
Medicamento: Rescue Medication

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
Experimental: 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.
Medicamento: Leucovorin

IV infusion

Biológico: Pembrolizumab

IV infusion

Outros nomes:
  • MK-3475
  • KEYTRUDA®
Medicamento: Levoleucovorin

IV infusion

Medicamento: 5-Fluorouracil (5-FU)

IV Infusion

Medicamento: Rescue Medication

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

Biológico: Sacituzumab tirumotecan

IV infusion

Outros nomes:
  • SKB264
  • MK-2870

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase
Prazo: 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
Percentage of Participants who Experience an Adverse Event (AE)
Prazo: 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
Objective Response Rate (ORR)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Duration of Response (DOR)
Prazo: 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
Progression-Free Survival (PFS)
Prazo: 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
Overall Survival (OS)
Prazo: 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
Disease Control Rate (DCR)
Prazo: 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
Maximum Plasma Concentration (Cmax) of I-DXd
Prazo: 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
Time to Maximum Plasma Concentration (Tmax) of I-DXd
Prazo: 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
Area Under the Concentration-Time Curve from Time 0 to Last Measurable Plasma Concentration (AUClast) of I-DXd
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Merck Sharp & Dohme LLC

Colaboradores

Daiichi Sankyo

Investigadores

  • Diretor de estudo: Medical Director, Merck Sharp & Dohme LLC

Publicações e links úteis

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Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

30 de julho de 2025

Conclusão Primária (Estimado)

4 de janeiro de 2032

Conclusão do estudo (Estimado)

4 de janeiro de 2032

Datas de inscrição no estudo

Enviado pela primeira vez

13 de janeiro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de janeiro de 2025

Primeira postagem (Real)

17 de janeiro de 2025

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 3475-06E
  • MK-3475-06E (Outro identificador: MSD)
  • U1111-1307-6484 (Identificador de registro: UTN)
  • jRCT2041240166 (Identificador de registro: Japan Registry of Clinical Trials (jRCT))
  • 2024-514273-22-00 (Identificador de registro: EU CT)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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