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子研究 06E：食管癌联合疗法的总体研究 (MK-3475-06E/KEYMAKER-U06)

2026年10月23日 更新者：Merck Sharp & Dohme LLC

在 1L 局部晚期不可切除/转移性食管癌受试者中，研究药物与 Pembrolizumab (MK-3475) 联合化疗或不化疗的 1/2 期开放标签、伞式平台设计研究：KEYMAKER-U06 子研究 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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

The master protocol is MK-3475-U06.

研究类型

介入性

注册 (估计的)

298

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：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.
药品：Leucovorin

IV infusion

生物：Pembrolizumab

IV infusion

其他名称：
  • MK-3475
  • 可瑞达®
药品：Oxaliplatin

IV infusion

药品：Levoleucovorin

IV infusion

药品：5-Fluorouracil (5-FU)

IV Infusion
实验性的：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.
生物：Pembrolizumab

IV infusion

其他名称：
  • MK-3475
  • 可瑞达®
生物：I-DXd

IV infusion

其他名称：
  • DS-7300a
  • MK-2400
  • 伊非那单抗
药品：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
实验性的：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.
药品：Leucovorin

IV infusion

生物：Pembrolizumab

IV infusion

其他名称：
  • MK-3475
  • 可瑞达®
药品：Levoleucovorin

IV infusion

药品：5-Fluorouracil (5-FU)

IV Infusion

生物：I-DXd

IV infusion

其他名称：
  • DS-7300a
  • MK-2400
  • 伊非那单抗
药品：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
实验性的：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.
药品：Leucovorin

IV infusion

生物：Pembrolizumab

IV infusion

其他名称：
  • MK-3475
  • 可瑞达®
药品：Oxaliplatin

IV infusion

药品：Levoleucovorin

IV infusion

药品：5-Fluorouracil (5-FU)

IV Infusion

生物：I-DXd

IV infusion

其他名称：
  • DS-7300a
  • MK-2400
  • 伊非那单抗
药品：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
实验性的：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.
药品：Leucovorin

IV infusion

生物：Pembrolizumab

IV infusion

其他名称：
  • MK-3475
  • 可瑞达®
药品：Levoleucovorin

IV infusion

药品：5-Fluorouracil (5-FU)

IV Infusion

药品：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

生物：Sacituzumab tirumotecan

IV infusion

其他名称：
  • SKB264
  • MK-2870

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase
大体时间：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)
大体时间：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)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Duration of Response (DOR)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Merck Sharp & Dohme LLC

合作者

Daiichi Sankyo

调查人员

  • 研究主任：Medical Director、Merck Sharp & Dohme LLC

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年7月30日

初级完成 (估计的)

2032年1月4日

研究完成 (估计的)

2032年1月4日

研究注册日期

首次提交

2025年1月13日

首先提交符合 QC 标准的

2025年1月13日

首次发布 (实际的)

2025年1月17日

研究记录更新

最后更新发布 (实际的)

2026年10月27日

上次提交的符合 QC 标准的更新

2026年10月23日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 3475-06E
  • MK-3475-06E (其他标识符：MSD)
  • U1111-1307-6484 (注册表标识符：UTN)
  • jRCT2041240166 (注册表标识符：Japan Registry of Clinical Trials (jRCT))
  • 2024-514273-22-00 (注册表标识符：EU CT)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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