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子研究 06C：一项 Sacituzumab Tirumotecan (MK-2870) 联合 Pembrolizumab (MK-3475) 和化疗在一线局部晚期不可切除/转移性胃食管腺癌 (MK-3475-06C/KEYMAKER-U06) 受试者中的研究

2026年11月12日 更新者：Merck Sharp & Dohme LLC

一项针对 1L 局部晚期不可切除/转移性胃食管腺癌（胃腺癌、胃食管交界处腺癌和食管腺癌）受试者进行 MK-2870 联合 Pembrolizumab (MK-3475) 和化疗的 1/2 期开放标签、伞式平台设计研究：子研究 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.

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)

160

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
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100142
        • 招聘中
        • Beijing Cancer hospital-Digestive Oncology ( Site 5500)
        • 接触：
          • Study Coordinator
          • 电话号码：(010)88196317
    • Fujian
      • Fuzhou、Fujian、中国、350025
        • 招聘中
        • The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 5501)
        • 接触：
          • Study Coordinator
          • 电话号码：0591-22859606
      • Xiamen、Fujian、中国、361003
        • 招聘中
        • The First Affiliated hospital of Xiamen University ( Site 5503)
        • 接触：
          • Study Coordinator
          • 电话号码：0592-2139767
    • Henan
      • Zhengzhou、Henan、中国、450008
        • 招聘中
        • Henan Cancer Hospital ( Site 5504)
        • 接触：
          • Study Coordinator
          • 电话号码：400-0371-818
    • Jiangxi
      • Nanchang、Jiangxi、中国、330000
        • 招聘中
        • The First Affiliated Hospital of Nanchang University ( Site 5514)
        • 接触：
          • Study Coordinator
          • 电话号码：0791-86427234
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200032
        • 主动，不招人
        • Fudan University Shanghai Cancer Center ( Site 5513)
    • Xinjiang
      • Ürümqi、Xinjiang、中国、841100
        • 主动，不招人
        • Xinjiang Medical University Cancer Hospital - Urumqi ( Site 5506)
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310016
        • 招聘中
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5510)
        • 接触：
          • Study Coordinator
          • 电话号码：0571 8609 0073
  • 台湾
      • Taichung、台湾、404
        • 招聘中
        • China Medical University Hospital ( Site 6007)
        • 接触：
          • Study Coordinator
          • 电话号码：886422052121x15057
      • Tainan、台湾、704
        • 招聘中
        • National Cheng Kung University Hospital ( Site 6001)
        • 接触：
          • Study Coordinator
          • 电话号码：+88662353535x4559
      • Taipei、台湾、10048
        • 招聘中
        • National Taiwan University Hospital-Oncology ( Site 6000)
        • 接触：
          • Study Coordinator
          • 电话号码：+88623123456x267852
      • Taipei、台湾、112
        • 招聘中
        • Taipei Veterans General Hospital ( Site 6005)
        • 接触：
          • Study Coordinator
          • 电话号码：+88628717270x131
  • 巴西
      • São Paulo、巴西、03102-006
        • 招聘中
        • IBCC - Instituto Brasileiro de Controle do Câncer ( Site 6304)
        • 接触：
          • Study Coordinator
          • 电话号码：551144500300
      • São Paulo、巴西、01246-000
        • 招聘中
        • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 6300)
        • 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 Câncer ( Site 6303)
        • 接触：
          • Study Coordinator
          • 电话号码：+558440095595
    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、巴西、91350-200
        • 招聘中
        • Hospital Nossa Senhora da Conceição ( Site 6301)
        • 接触：
          • Study Coordinator
          • 电话号码：+5551993590437
  • 德国
    • Baden-Wurttemberg
      • Heidelberg、Baden-Wurttemberg、德国、69120
        • 招聘中
        • NCT-Department of Medical Oncology ( Site 6809)
        • 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 6807)
        • 接触：
          • Study Coordinator
          • 电话号码：+ 4940360352246
    • North Rhine-Westphalia
      • Düsseldorf、North Rhine-Westphalia、德国、40225
        • 完全的
        • Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 6802)
  • 意大利
      • Milan、意大利、20132
        • 招聘中
        • Ospedale San Raffaele-Oncologia Medica ( Site 5202)
        • 接触：
          • Study Coordinator
          • 电话号码：+390226437615
    • Emilia-Romagna
      • Meldola、Emilia-Romagna、意大利、47014
        • 招聘中
        • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 5207)
        • 接触：
          • Study Coordinator
          • 电话号码：0543739100
    • Lombardy
      • Milan、Lombardy、意大利、20133
        • 招聘中
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 5200)
        • 接触：
          • Study Coordinator
          • 电话号码：0223903807
    • Tuscany
      • Pisa、Tuscany、意大利、56126
        • 招聘中
        • Azienda Ospedaliero Universitaria Pisana ( Site 5206)
        • 接触：
          • Study Coordinator
          • 电话号码：050992454
  • 挪威
      • Oslo、挪威、0379
        • 招聘中
        • Oslo universitetssykehus, Radiumhospitalet ( Site 6501)
        • 接触：
          • Study Coordinator
          • 电话号码：4723026600
  • 智利
      • Antofagasta、智利、1263521
        • 招聘中
        • Bradford Hill Norte ( Site 6407)
        • 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 6409)
        • 接触：
          • Study Coordinator
          • 电话号码：56961687093
    • Maule Region
      • Talca、Maule Region、智利、3481349
        • 完全的
        • Centro de Investigación del Maule ( Site 6408)
    • Region M. de Santiago
      • Santiago、Region M. de Santiago、智利、7500921
        • 招聘中
        • FALP-UIDO ( Site 6400)
        • 接触：
          • Study Coordinator
          • 电话号码：56224205098
      • Santiago、Region M. de Santiago、智利、7560908
        • 招聘中
        • Centro de Oncología de Precisión-Oncology ( Site 6404)
        • 接触：
          • Study Coordinator
          • 电话号码：56225189885
      • Santiago、Region M. de Santiago、智利、7620002
        • 招聘中
        • Clínica UC San Carlos de Apoquindo ( Site 6405)
        • 接触：
          • Study Coordinator
          • 电话号码：56934271024
      • Santiago、Region M. de Santiago、智利、8420383
        • 招聘中
        • Bradfordhill-Clinical Area ( Site 6401)
        • 接触：
          • Study Coordinator
          • 电话号码：56229490970
  • 法国
    • Finistere
      • Brest、Finistere、法国、29200
        • 招聘中
        • CHU-BREST Cavale Blanche ( Site 5104)
        • 接触：
          • Study Coordinator
          • 电话号码：33298223428
    • Nord
      • Lille、Nord、法国、59037
        • 招聘中
        • CIC. ( Site 5100)
        • 接触：
          • Study Coordinator
          • 电话号码：+33320445461
    • Île-de-France Region
      • Paris、Île-de-France Region、法国、75013
        • 招聘中
        • Pitie Salpetriere University Hospital-Hepato-Gastro-Enterology ( Site 5102)
        • 接触：
          • Study Coordinator
          • 电话号码：+331 42 16 10 41
  • 泰国
    • Bangkok
      • Bangkoknoi、Bangkok、泰国、10700
        • 招聘中
        • Faculty of Medicine Siriraj Hospital ( Site 6102)
        • 接触：
          • Study Coordinator
          • 电话号码：+6624194489
      • Pathumwan、Bangkok、泰国、10330
        • 招聘中
        • Chulalongkorn Hospital ( Site 6104)
        • 接触：
          • Study Coordinator
          • 电话号码：022564533
      • Ratchathewi、Bangkok、泰国、10400
        • 招聘中
        • Ramathibodi Hospital ( Site 6103)
        • 接触：
          • Study Coordinator
          • 电话号码：022011671
    • Changwat Songkhla
      • Hat Yai、Changwat Songkhla、泰国、90110
        • 招聘中
        • Songklanagarind hospital ( Site 6101)
        • 接触：
          • Study Coordinator
          • 电话号码：+6674451469
  • 瑞士
    • Canton of Geneva
      • Geneva、Canton of Geneva、瑞士、1211
        • 招聘中
        • Hôpitaux Universitaires de Genève (HUG) ( Site 6701)
        • 接触：
          • Study Coordinator
          • 电话号码：+41 22 372 29 01
    • Kanton Graubünden
      • Chur、Kanton Graubünden、瑞士、7000
        • 招聘中
        • Kantonsspital Graubünden-Medizin ( Site 6700)
        • 接触：
          • Study Coordinator
          • 电话号码：+41 81 256 61 11
  • 美国
    • Arizona
      • Tucson、Arizona、美国、85719
        • 招聘中
        • University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 6927)
        • 接触：
          • Study Coordinator
          • 电话号码：520-621-2449
    • California
      • Los Angeles、California、美国、90404
        • 招聘中
        • UCLA Hematology/Oncology - Santa Monica ( Site 6905)
        • 接触：
          • Study Coordinator
          • 电话号码：310-570-1453
    • Kentucky
      • Louisville、Kentucky、美国、40202
        • 完全的
        • Norton Hospital-Norton Cancer Institute - Downtown ( Site 6900)
    • Michigan
      • Grand Rapids、Michigan、美国、49503
        • 招聘中
        • The Cancer and Hematology Centers ( Site 6912)
        • 接触：
          • Study Coordinator
          • 电话号码：616-975-3065
    • New York
      • East Syracuse、New York、美国、13057
        • 招聘中
        • Hematology-Oncology Associates of Central NY, P.C. ( Site 6925)
        • 接触：
          • Study Coordinator
          • 电话号码：315-472-7504
      • New York、New York、美国、10032
        • 完全的
        • Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 6907)
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15232
        • 招聘中
        • UPMC Hillman Cancer Center-UPMC ( Site 6904)
        • 接触：
          • Study Coordinator
          • 电话号码：816-898-9413
    • Texas
      • Houston、Texas、美国、77030
        • 招聘中
        • University of Texas MD Anderson Cancer Center ( Site 6920)
        • 接触：
          • Study Coordinator
          • 电话号码：833-589-0868
  • 韩国
      • Seoul、韩国、05505
        • 招聘中
        • Asan Medical Center-Department of Oncology ( Site 5901)
        • 接触：
          • Study Coordinator
          • 电话号码：+82230103217
      • Seoul、韩国、06351
        • 招聘中
        • Samsung Medical Center-Division of Hematology/Oncology ( Site 5900)
        • 接触：
          • Study Coordinator
          • 电话号码：82234101795

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 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

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 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).
生物：Pembrolizumab

Administered via intravenous (IV) infusion.

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

Administered via oral tablet.

其他名称：
  • 希罗达
药品：Leucovorin

Administered via IV infusion.

其他名称：
  • 亚叶酸
  • WELLCOVORIN®
  • 亚叶酸钙
药品：Levoleucovorin

Administered via IV infusion.

其他名称：
  • FUSILEV®
  • 左亚叶酸钙
  • 左亚叶酸
药品：5-Fluorouracil (5-FU)

Administered via IV infusion

其他名称：
  • ADRUCIL®
药品：Oxaliplatin

Administered via IV infusion
实验性的：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.
生物：Pembrolizumab

Administered via intravenous (IV) infusion.

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

Administered via oral tablet.

其他名称：
  • 希罗达
药品：Leucovorin

Administered via IV infusion.

其他名称：
  • 亚叶酸
  • WELLCOVORIN®
  • 亚叶酸钙
药品：Levoleucovorin

Administered via IV infusion.

其他名称：
  • FUSILEV®
  • 左亚叶酸钙
  • 左亚叶酸
药品：5-Fluorouracil (5-FU)

Administered via IV infusion

其他名称：
  • ADRUCIL®
生物：Sacituzumab Tirumotecan (sac-TMT)

Administered via IV infusion.

其他名称：
  • SKB264
  • MK-2870
实验性的：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.
生物：Pembrolizumab

Administered via intravenous (IV) infusion.

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

Administered via oral tablet.

其他名称：
  • 希罗达
药品：Leucovorin

Administered via IV infusion.

其他名称：
  • 亚叶酸
  • WELLCOVORIN®
  • 亚叶酸钙
药品：Levoleucovorin

Administered via IV infusion.

其他名称：
  • FUSILEV®
  • 左亚叶酸钙
  • 左亚叶酸
药品：5-Fluorouracil (5-FU)

Administered via IV infusion

其他名称：
  • ADRUCIL®
生物：Patritumab Deruxtecan

Administered via IV infusion

其他名称：
  • U3-1402
  • HER3-DXd
  • MK-1022

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
Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
大体时间：Up to approximately 28 days

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
Safety Lead-in Phase: Number of Participants Who Experienced an Adverse Event (AE)
大体时间：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
Safety Lead-in Phase: Number of Participants Who Discontinued Study Intervention Due to an AE
大体时间：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
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)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR
大体时间：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
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
大体时间：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
Overall Survival (OS)
大体时间：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
Number of Participants Who Experience an Adverse Event (AE)
大体时间：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
大体时间：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))
大体时间：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

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

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)

2024年9月20日

初级完成 (估计的)

2029年9月12日

研究完成 (估计的)

2029年9月12日

研究注册日期

首次提交

2024年6月17日

首先提交符合 QC 标准的

2024年6月17日

首次发布 (实际的)

2024年6月24日

研究记录更新

最后更新发布 (实际的)

2026年11月13日

上次提交的符合 QC 标准的更新

2026年11月12日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 3475-06C
  • MK-3475-06C (其他标识符：MSD)
  • KEYMAKER-06C (其他标识符：MSD)
  • U1111-1299-8084 (注册表标识符：UTN)
  • 2023-509307-33-00 (注册表标识符：EU CT)
  • 2023 (美国 NIH 拨款/合同)

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

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