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An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC (TU-04)

2026年7月17日 更新者：AstraZeneca

A Phase III, Open-Label, Randomised, Multicentre, Global Study of Adjuvant Datopotamab Deruxtecan in Combination With Rilvegostomig in Participants With High-risk Muscle Invasive Urothelial Carcinoma

Purpose: to assess efficacy and safety of Dato-DXd + rilvegostomig as adjuvant therapy versus SoC in MIUC participants with high-risk residual disease after radical resection.

Study details:

Duration: ~78 months (6.5 years) from FSI to last subject visit Treatment length: up to ~12 months, depending on randomized arm Visit frequency: every 3 weeks in Arms 1 and 2; every 2-4 weeks per SoC in Arm 3

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

915

阶段

  • 第三阶段

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、中国、100050
        • 尚未招聘
        • Research Site
      • Beijing、中国、100191
        • 尚未招聘
        • Research Site
      • Beijing、中国、100034
        • 尚未招聘
        • Research Site
      • Changsha、中国、410013
        • 尚未招聘
        • Research Site
      • Chengdu、中国、610072
        • 尚未招聘
        • Research Site
      • Chengdu、中国、610000
        • 尚未招聘
        • Research Site
      • Chongqing、中国、400030
        • 尚未招聘
        • Research Site
      • Chongqing、中国、400016
        • 尚未招聘
        • Research Site
      • Fuzhou、中国、350005
        • 尚未招聘
        • Research Site
      • Guangzhou、中国、510220
        • 尚未招聘
        • Research Site
      • Guangzhou、中国、510288
        • 尚未招聘
        • Research Site
      • Guiyang、中国、550044
        • 尚未招聘
        • Research Site
      • Hangzhou、中国、310003
        • 尚未招聘
        • Research Site
      • Hangzhou、中国、310009
        • 尚未招聘
        • Research Site
      • Harbin、中国、150049
        • 尚未招聘
        • Research Site
      • Jinan、中国、250012
        • 尚未招聘
        • Research Site
      • Jinan、中国、250021
        • 尚未招聘
        • Research Site
      • Kunming、中国、650101
        • 尚未招聘
        • Research Site
      • Kunming、中国、650118
        • 尚未招聘
        • Research Site
      • Lanzhou、中国、730030
        • 尚未招聘
        • Research Site
      • Nanchang、中国、330006
        • 尚未招聘
        • Research Site
      • Nanjing、中国、210008
        • 尚未招聘
        • Research Site
      • Nanning、中国、530021
        • 尚未招聘
        • Research Site
      • Ningbo、中国、315010
        • 尚未招聘
        • Research Site
      • Qingdao、中国、266003
        • 尚未招聘
        • Research Site
      • Shanghai、中国、200040
        • 尚未招聘
        • Research Site
      • Shenyang、中国、110042
        • 尚未招聘
        • Research Site
      • Shenyang、中国、110004
        • 尚未招聘
        • Research Site
      • Suining Shi、中国、629000
        • 尚未招聘
        • Research Site
      • Tianjin、中国、300211
        • 尚未招聘
        • Research Site
      • Wenzhou、中国、325000
        • 尚未招聘
        • Research Site
      • Wuhan、中国、430022
        • 尚未招聘
        • Research Site
      • Wuhan、中国、430030
        • 尚未招聘
        • Research Site
      • Xuzhou、中国、221000
        • 尚未招聘
        • Research Site
      • Zhengzhou、中国、450008
        • 尚未招聘
        • Research Site
  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 5G2
        • 尚未招聘
        • Research Site
    • British Columbia
      • Abbotsford British Columbia、British Columbia、加拿大、V2S0C2
        • 尚未招聘
        • Research Site
    • Ontario
      • Barrie、Ontario、加拿大、L4M 6M2
        • 招聘中
        • Research Site
      • Hamilton、Ontario、加拿大、L8V 5C2
        • 招聘中
        • Research Site
      • Kingston、Ontario、加拿大、K7L 2V7
        • 尚未招聘
        • Research Site
      • London、Ontario、加拿大、N6C 2R5
        • 尚未招聘
        • Research Site
      • Mississauga、Ontario、加拿大、L5M 2N1
        • 尚未招聘
        • Research Site
    • Quebec
      • Montreal、Quebec、加拿大、H2X 0A9
        • 尚未招聘
        • Research Site
      • Montreal、Quebec、加拿大、H3A 1A1
        • 尚未招聘
        • Research Site
  • 印度
      • Kolkata、印度、700160
        • 尚未招聘
        • Research Site
      • Kottayam、印度、686008
        • 尚未招聘
        • Research Site
      • Nashik、印度、422011
        • 尚未招聘
        • Research Site
      • Navi Mumbai、印度、410210
        • 尚未招聘
        • Research Site
      • New Delhi、印度、110085
        • 尚未招聘
        • Research Site
      • New Delhi、印度、110076
        • 尚未招聘
        • Research Site
      • New Delhi、印度、11029
        • 尚未招聘
        • Research Site
  • 台湾
      • Kaohsiung City、台湾、80756
        • 招聘中
        • Research Site
      • Kaohsiung City、台湾、83301
        • 尚未招聘
        • Research Site
      • Kaohsiung City、台湾、813
        • 尚未招聘
        • Research Site
      • Tainan、台湾、704
        • 尚未招聘
        • Research Site
      • Taipei、台湾、11217
        • 尚未招聘
        • Research Site
      • Taoyuan、台湾、333
        • 尚未招聘
        • Research Site
  • 巴西
      • Barretos、巴西、14784-400
        • 尚未招聘
        • Research Site
      • Curitiba、巴西、81520-060
        • 尚未招聘
        • Research Site
      • Salvador、巴西、41950-640
        • 尚未招聘
        • Research Site
      • São Paulo、巴西、05652-900
        • 尚未招聘
        • Research Site
      • São Paulo、巴西、01323-903
        • 尚未招聘
        • Research Site
  • 德国
      • Bochum、德国、44791
        • 尚未招聘
        • Research Site
      • Bonn、德国、53127
        • 尚未招聘
        • Research Site
      • Dresden、德国、01307
        • 尚未招聘
        • Research Site
      • Duisburg、德国、47169
        • 尚未招聘
        • Research Site
      • Frankfurt am Main、德国、60431
        • 尚未招聘
        • Research Site
      • Hamburg、德国、20246
        • 尚未招聘
        • Research Site
      • Hanover、德国、30625
        • 尚未招聘
        • Research Site
      • Herne、德国、44625
        • 尚未招聘
        • Research Site
      • Magdeburg、德国、39120
        • 尚未招聘
        • Research Site
      • Mannheim、德国、68167
        • 尚未招聘
        • Research Site
      • Marburg、德国、35043
        • 尚未招聘
        • Research Site
      • Mettmann、德国、40822
        • 尚未招聘
        • Research Site
      • Münster、德国、48149
        • 尚未招聘
        • Research Site
      • Nuremberg、德国、90419
        • 尚未招聘
        • Research Site
      • Nürtingen、德国、72622
        • 尚未招聘
        • Research Site
      • Regensburg、德国、93053
        • 尚未招聘
        • Research Site
      • Rostock、德国、18057
        • 尚未招聘
        • Research Site
      • Stuttgart、德国、70174
        • 尚未招聘
        • Research Site
      • Tübingen、德国、72076
        • 尚未招聘
        • Research Site
      • Ulm、德国、89081
        • 尚未招聘
        • Research Site
  • 意大利
      • Bari、意大利、70120
        • 尚未招聘
        • Research Site
      • Florence、意大利、50134
        • 尚未招聘
        • Research Site
      • Padova、意大利、35128
        • 尚未招聘
        • Research Site
      • Roma、意大利、00168
        • 尚未招聘
        • Research Site
      • Rozzano、意大利、20089
        • 尚未招聘
        • Research Site
      • Tricase、意大利、73039
        • 尚未招聘
        • Research Site
  • 日本
      • Fukuoka、日本、812-8582
        • 尚未招聘
        • Research Site
      • Fukuoka、日本、811-1347
        • 尚未招聘
        • Research Site
      • Hamamatsu、日本、431-3192
        • 尚未招聘
        • Research Site
      • Hirosaki-shi、日本、036-8563
        • 撤销
        • Research Site
      • Kanazawa、日本、920-8641
        • 尚未招聘
        • Research Site
      • Kashihara-shi、日本、634-8522
        • 尚未招聘
        • Research Site
      • Kawasaki-shi、日本、216-8511
        • 尚未招聘
        • Research Site
      • Kita-gun、日本、761-0793
        • 撤销
        • Research Site
      • Kobe、日本、650-0017
        • 尚未招聘
        • Research Site
      • Kumamoto、日本、860-0008
        • 尚未招聘
        • Research Site
      • Kōtoku、日本、135-8550
        • 尚未招聘
        • Research Site
      • Nagasaki、日本、852-8501
        • 尚未招聘
        • Research Site
      • Nagoya、日本、466-8560
        • 尚未招聘
        • Research Site
      • Osaka、日本、545-8586
        • 尚未招聘
        • Research Site
      • Osaka、日本、541-8567
        • 尚未招聘
        • Research Site
      • Toyama、日本、930-0194
        • 尚未招聘
        • Research Site
      • Tsukuba、日本、305-8576
        • 尚未招聘
        • Research Site
  • 法国
      • Bordeaux、法国、33000
        • 尚未招聘
        • Research Site
      • Montpellier、法国、34298
        • 尚未招聘
        • Research Site
      • Paris、法国、75014
        • 尚未招聘
        • Research Site
      • Pierre-Bénite、法国、69310
        • 尚未招聘
        • Research Site
      • Poitiers、法国、86000
        • 尚未招聘
        • Research Site
      • Strasbourg、法国、67098
        • 尚未招聘
        • Research Site
  • 波兰
      • Gdansk、波兰、80-952
        • 尚未招聘
        • Research Site
      • Koszalin、波兰、75-581
        • 尚未招聘
        • Research Site
      • Poznan、波兰、61-731
        • 尚未招聘
        • Research Site
      • Siedlce、波兰、08-110
        • 尚未招聘
        • Research Site
      • Skórzewo、波兰、60-185
        • 尚未招聘
        • Research Site
      • Wroclaw、波兰、53-413
        • 尚未招聘
        • Research Site
      • Wroclaw、波兰、50-556
        • 尚未招聘
        • Research Site
  • 泰国
      • Bangkok、泰国、10700
        • 尚未招聘
        • Research Site
      • Hat Yai、泰国、90110
        • 尚未招聘
        • Research Site
  • 澳大利亚
      • Auchenflower、澳大利亚、4066
        • 撤销
        • Research Site
      • Ballarat、澳大利亚、3350
        • 尚未招聘
        • Research Site
      • Clayton、澳大利亚、3168
        • 尚未招聘
        • Research Site
      • Darlinghurst、澳大利亚、2010
        • 尚未招聘
        • Research Site
      • Elizabeth Vale、澳大利亚、5112
        • 尚未招聘
        • Research Site
      • South Brisbane、澳大利亚、4101
        • 尚未招聘
        • Research Site
      • St Albans、澳大利亚、3021
        • 撤销
        • Research Site
  • 美国
    • Arkansas
      • Hot Springs、Arkansas、美国、71913
        • 尚未招聘
        • Research Site
      • Little Rock、Arkansas、美国、72205
        • 尚未招聘
        • Research Site
      • Little Rock、Arkansas、美国、72211
        • 尚未招聘
        • Research Site
    • California
      • San Francisco、California、美国、94143
        • 尚未招聘
        • Research Site
    • Illinois
      • Chicago、Illinois、美国、60637
        • 撤销
        • Research Site
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • 尚未招聘
        • Research Site
    • Missouri
      • Kansas City、Missouri、美国、64132
        • 尚未招聘
        • Research Site
    • Nebraska
      • Lincoln、Nebraska、美国、68506
        • 尚未招聘
        • Research Site
      • Omaha、Nebraska、美国、68130
        • 尚未招聘
        • Research Site
    • New York
      • Albany、New York、美国、12208
        • 尚未招聘
        • Research Site
      • New York、New York、美国、10065
        • 尚未招聘
        • Research Site
    • Ohio
      • Cleveland、Ohio、美国、44195
        • 尚未招聘
        • Research Site
    • South Carolina
      • Myrtle Beach、South Carolina、美国、29572
        • 尚未招聘
        • Research Site
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • 尚未招聘
        • Research Site
    • Texas
      • Dallas、Texas、美国、75235
        • 尚未招聘
        • Research Site
    • Virginia
      • Falls Church、Virginia、美国、22042
        • 尚未招聘
        • Research Site
    • Washington
      • Seattle、Washington、美国、98109
        • 尚未招聘
        • Research Site
      • Tacoma、Washington、美国、98405
        • 尚未招聘
        • Research Site
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • 尚未招聘
        • Research Site
  • 英国
      • Bristol、英国、BS2 8ED
        • 尚未招聘
        • Research Site
      • Cambridge、英国、CB2 0QQ
        • 尚未招聘
        • Research Site
      • Preston、英国、PR2 9HT
        • 尚未招聘
        • Research Site
      • Sheffield、英国、S10 2SJ
        • 尚未招聘
        • Research Site
  • 西班牙
      • L'Hospitalet de Llobregat、西班牙、08908
        • 尚未招聘
        • Research Site
      • Las Palmas de Gran Canaria、西班牙、35016
        • 尚未招聘
        • Research Site
      • Madrid、西班牙、28040
        • 尚未招聘
        • Research Site
      • Santander、西班牙、39008
        • 尚未招聘
        • Research Site
      • Seville、西班牙、41013
        • 尚未招聘
        • Research Site
  • 韩国
      • Seoul、韩国、3722
        • 尚未招聘
        • Research Site
      • Seoul、韩国、03080
        • 尚未招聘
        • Research Site
      • Seoul、韩国、06591
        • 尚未招聘
        • Research Site
      • Seoul、韩国、5505
        • 尚未招聘
        • Research Site
      • Seoul、韩国、6351
        • 尚未招聘
        • Research Site

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion criteria:

  1. Participant must be > 18 years of age at the time of signing the ICF.
  2. Histologically confirmed MIUC of the bladder or upper tract.
  3. Completed R0 radical resection 28 to 120 days before randomisation, with negative margins and no residual or metastatic disease.

  4. Pathologic evidence of urothelial carcinoma at high-risk of recurrence and

    1. not received neoadjuvant therapy and has pT3-pT4aN0, or any pT with pN+ stage
    2. completed neoadjuvant treatment and has ypT2-ypT4a, or any ypT with ypN+ stage
  5. No evidence of disease at screening,
  6. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to randomisation.
  7. Minimum life expectancy of > 12 weeks at time of screening.
  8. An archival surgical tumour sample must be available pre-randomisation for central testing.
  9. Adequate organ and bone marrow function within 28 days before randomisation.

Exclusion criteria:

  1. Any tumour with predominant or pure high grade neuroendocrine carcinoma component.
  2. Partial cystectomy in the setting of bladder cancer primary tumour or partial nephrectomy.
  3. Any adjuvant systemic or radiation therapy post-surgery for urothelial carcinoma.
  4. Severe or uncontrolled systemic diseases, history of organ transplant or allogeneic stem cell transplant, or psychological disorders/social situations, and/or substance abuse.
  5. History of clinically significant corneal disease.
  6. History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention and of low potential risk for recurrence.
  7. Ongoing toxicities except alopecia from prior cancer treatment must be Grade ≤ 1 or at baseline. Stable Grade 2 toxicities are allowed if unchanged for ≥3 months and managed by standard care.
  8. Active or uncontrolled hepatitis B or C virus infection.
  9. Known HIV infection that is not well controlled.
  10. Any other active or uncontrolled infection including tuberculosis requiring systemic treatment that has not resolved by the time of randomisation.
  11. History of non-infectious ILD/pneumonitis including radiation, pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
  12. Has clinically severe pulmonary function compromise.
  13. Mean resting corrected QTcF > 470 ms regardless of gender, obtained from triplicate 12-lead ECGs performed at screening
  14. Uncontrolled or significant cardiac conditions.
  15. Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment in the past 5 years.
  16. Prior exposure to TROP2-directed therapies, other ADCs with deruxtecan, therapeutic anti-cancer vaccines, anti-TIGIT therapy or any other anti-cancer therapy targeting immune-regulatory receptors or mechanisms.
  17. Current or prior use of immunosuppressive medication within 14 days prior to treatment assignment/randomisation.
  18. Known history of severe hypersensitivity reactions to any study drug
  19. Not eligible to receive at least one of SoC according to local regulations/approvals.
  20. Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.

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：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Arm 1: Dato-DXd + rilvegostomig
Dato-DXd: 6 mg/kg IV Q3W for 9 cycles (approximately 6 months), can be extended based on Investigator assessment of tolerability up to 17 cycles or up to 1 year + rilvegostomig: 750 mg IV Q3W 17 cycles or up to 1 year whichever occurs first.
药品：Dato-DXd
Dato-DXd is an ADC comprised of a recombinant humanised anti-TROP2 IgG1 mAb, MAAP-9001a, which is covalently conjugated via a cleavable drug-linker, MAAA1162a (the complex of MAAA-1181a and a maleimide tetrapeptide linker), using thioether bonds to the topoisomerase I inhibitor DXd.
其他名称：
  • Datopotamab deruxtecan
  • (Dato-DXd, DS-1062a)
药品：Rilvegostomig
Rilvegostomig is a monovalent, bispecific, humanised, IgG1 mAb engineered with an Fc domain that carries a triple mutation (L234F/L235E/P331S) designed to reduce Fc-mediated effector functions. Rilvegostomig contains 2 distinct paratopes that bind to human TIGIT and PD-1 and inhibit binding to their respective immuno-suppressive ligands.
其他名称：
  • AZD2936
实验性的：Arm 2: Dato-DXd monotherapy
Dato-DXd: 6 mg/kg IV Q3W for 9 cycles (approximately 6 months), can be extended based on Investigator assessment of tolerability up to 17 cycles or up to 1 year.
药品：Dato-DXd
Dato-DXd is an ADC comprised of a recombinant humanised anti-TROP2 IgG1 mAb, MAAP-9001a, which is covalently conjugated via a cleavable drug-linker, MAAA1162a (the complex of MAAA-1181a and a maleimide tetrapeptide linker), using thioether bonds to the topoisomerase I inhibitor DXd.
其他名称：
  • Datopotamab deruxtecan
  • (Dato-DXd, DS-1062a)
有源比较器：Arm 3 (SoC): nivolumab or durvalumab or EV + pembrolizumab

Either: Nivolumab: 240 mg IV Q2W OR 480 mg IV Q4W up to 1 year

Or: Durvalumab: 1500 mg IV Q4W for 8 cycles (or at a dose of 20 mg/kg Q4W in participants who weigh ≤ 30 kg)

Or: EV 1.25 mg/kg D1, D8 Q3W up to 6 cycles + pembrolizumab 200 mg IV Q3W up to 14 cycles or 400 mg IV Q6W up to 7 cycles.
药品：Durvalumab
A fully human monoclonal antibody that blocks the PD-L1 checkpoint to restore anti-tumor T-cell activity. Durvalumab is approved for Muscle invasive bladder cancer (MIBC) as perioperative regime.
其他名称：
  • Imfinzi, MEDI4736
药品：Nivolumab
A fully human monoclonal antibody against PD-1, promoting anti-tumor immunity. Approved across many malignancies such as melanoma, NSCLC, renal cell carcinoma, Hodgkin lymphoma, hepatocellular carcinoma, and colorectal cancer (dMMR/MSI-H), often alone or with ipilimumab. It's used in several cancers, notably unresectable stage III non-small cell lung cancer after chemoradiation and extensive-stage small cell lung cancer in combination regimens, among others, and is also approved for patients with muscle-invasive urothelial carcinoma (MIUC) at high risk of recurrence in the adjuvant setting.
其他名称：
  • OPDIVO®, BMS-936558
药品：Pembrolizumab
A humanized monoclonal antibody targeting PD-1, enhancing T-cell-mediated immune responses against tumors. Indications span multiple cancers including melanoma, NSCLC, head and neck squamous cell carcinoma, urothelial carcinoma, MSI-H/dMMR tumors, and more.
其他名称：
  • Keytruda，MK-3475
药品：Enfortumab vedotin

An antibody-drug conjugate (ADC) comprised of a fully human anti-Nectin-4 IgG1 monoclonal antibody, linked via a protease-cleavable maleimide-based linker to the microtubule-disrupting agent monomethyl auristatin E (MMAE), which is conjugated through thioether bonds.

Upon binding to Nectin-4-expressing cells, the ADC is internalized and releases MMAE, leading to disruption of microtubule dynamics and subsequent tumor cell death. Enfortumab vedotin is approved in urothelial cancers.

其他名称：
  • Padcev®, ASG-22CE, AGS-22M6E

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
To demonstrate the superiority of Dato-DXd + rilvegostomig (Arm 1) relative to SoC (Arm 3) by assessment of disease-free survival (DFS) (based on Investigator assessments).
大体时间：From randomisation until disease recurrence as assessed by investigator or death due to any cause (anticipated to be up to 49 months after the first subject in).
DFS is defined as the time from randomisation until disease recurrence (local urothelial tract, local non urothelial tract or distant) per RECIST 1.1 as assessed by Investigator, or death due to any cause. The analysis will include all randomised participants as randomised. All events will be included, regardless of whether the participant discontinues study treatment or receives another anti-cancer therapy. The measure of interest is the HR of DFS.
From randomisation until disease recurrence as assessed by investigator or death due to any cause (anticipated to be up to 49 months after the first subject in).

次要结果测量

结果测量
措施说明
大体时间
To demonstrate the superiority of Dato-DXd + rilvegostomig (Arm 1) relative to SoC (Arm 3) by assessment of OS (Overall survival).
大体时间：OS is defined as the time from randomisation until the date of death due to any cause, up to 78 months from first subject in.
OS defined as the time from randomisation until the date of death due to any cause. The analysis will include all randomised participants as randomised. All deaths will be included regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy. The measure of interest is the HR of OS.
OS is defined as the time from randomisation until the date of death due to any cause, up to 78 months from first subject in.
To demonstrate the superiority of Dato-DXd + rilvegostomig (Arm 1) relative to SoC (Arm 3) by assessment of DFS (based on Blinded Independent Central Review [BICR] assessments).
大体时间：From randomisation until disease recurrence as assessed by BICR or death due to any cause (anticipated to be up to 49 months after the first subject in).
DFS is defined as the time from randomisation until disease recurrence (local urothelial tract, local non urothelial tract or distant) per RECIST 1.1 as assessed by BICR, or death due to any cause. The analysis will include all randomised participants as randomised. All events will be included, regardless of whether the participant discontinues study treatment or receives another anti-cancer therapy. The measure of interest is the HR of DFS.
From randomisation until disease recurrence as assessed by BICR or death due to any cause (anticipated to be up to 49 months after the first subject in).
To estimate the effectiveness of Dato-DXd monotherapy (Arm 2) versus SoC (Arm 3) and effectiveness of Dato-DXd in combination with rilvegostomig (Arm 1) versus Dato-DXd monotherapy (Arm 2) by assessment of OS.
大体时间：OS is defined as the time from randomisation until the date of death due to any cause, up to 78 months from first subject in.
OS defined as the time from randomisation until the date of death due to any cause. The analysis will include all randomised participants as randomised. All deaths will be included regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy. The measure of interest is the HR of OS.
OS is defined as the time from randomisation until the date of death due to any cause, up to 78 months from first subject in.
To estimate the effectiveness of Dato-DXd monotherapy (Arm 2) versus SoC (Arm 3) and effectiveness of Dato-DXd in combination with rilvegostomig (Arm 1) versus Dato-DXd monotherapy (Arm 2) by assessment of DFS based on Investigator assessments.
大体时间：From randomisation until disease recurrence as assessed by investigator or death due to any cause (anticipated to be up to 49 months after the first subject in).
DFS is defined as the time from randomisation until disease recurrence (local urothelial tract, local non urothelial tract or distant) per RECIST 1.1 as assessed by Investigator, or death due to any cause. The analysis will include all randomised participants as randomised. All events will be included, regardless of whether the participant discontinues study treatment or receives another anti-cancer therapy. The measure of interest is the HR of DFS.
From randomisation until disease recurrence as assessed by investigator or death due to any cause (anticipated to be up to 49 months after the first subject in).
To estimate the effectiveness of Dato-DXd monotherapy (Arm 2) versus SoC (Arm 3) and effectiveness of Dato-DXd in combination with rilvegostomig (Arm 1) versus Dato-DXd monotherapy (Arm 2) by assessment of DFS by BICR.
大体时间：From randomisation until disease recurrence as assessed by BICR or death due to any cause (anticipated to be up to 49 months after the first subject in).
DFS is defined as the time from randomisation until disease recurrence (local urothelial tract, local non urothelial tract or distant) per RECIST 1.1 as assessed by BICR, or death due to any cause. The analysis will include all randomised participants as randomised. All events will be included, regardless of whether the participant discontinues study treatment or receives another anti-cancer therapy. The measure of interest is the HR of DFS.
From randomisation until disease recurrence as assessed by BICR or death due to any cause (anticipated to be up to 49 months after the first subject in).
To demonstrate effectiveness of Dato-DXd + rilvegostomig (Arm 1) vs SoC (Arm 3) by evaluating DSS (Disease specific survival), NUTRFS (Non-urothelial tract recurrence-free survival), DMFS (Distant metastasis free survival).
大体时间：From randomisation up to 49 months after the first subject in.

DSS is defined as time from randomisation until death due to disease (urothelial cancer). The analysis will include all randomised participants as randomised. The measure of interest is the HR of DSS.

NUTRFS is defined as time from randomisation until first local non-urothelial tract or distant recurrence or death due to any cause. The analysis will include all randomised participants as randomised. The measure of interest is the HR of NUTRFS.

DMFS is defined as time from randomisation until first distant recurrence (non-local) or death due to any cause The analysis will include all randomised participants as randomised. The measure of interest is the HR of DMFS.
From randomisation up to 49 months after the first subject in.

其他结果措施

结果测量
措施说明
大体时间
To assess the pharmacokinetics (PK) of Dato-DXd and DXd, alone in the Dato-DXd monotherapy arm (Arm 2) and in combination with rilvegostomig (Arm 1). To assess the PK of rilvegostomig in Arm 1.
大体时间：Day 1 of Cycles 1, 2, 4, 5, and 8 (each cycle is 21 days), at the end of treatment (approximately up to 12 months after randomization), and at the end of safety follow-up (approximately up to 15 months after randomization).
Concentration of Dato-DXd and DXd in plasma. Concentration of rilvegostomig in serum.
Day 1 of Cycles 1, 2, 4, 5, and 8 (each cycle is 21 days), at the end of treatment (approximately up to 12 months after randomization), and at the end of safety follow-up (approximately up to 15 months after randomization).
To investigate the immunogenicity of Dato-DXd and rilvegostomig in Dato-DXd + rilvegostomig combination therapy (Arm 1) and Dato-DXd monotherapy (Arm 2).
大体时间：Day 1 of Cycles 1, 2, 4, 5, 6, 8, 10, and 14 (each cycle is 21 days), at the end of treatment (approximately up to 12 months after randomization), and at the end of safety follow-up (approximately up to 15 months after randomization).
Presence of antidrug antibody (ADA) for Dato-DXd in plasma and rilvegostomig in serum (confirmatory results: positive or negative, titres).
Day 1 of Cycles 1, 2, 4, 5, 6, 8, 10, and 14 (each cycle is 21 days), at the end of treatment (approximately up to 12 months after randomization), and at the end of safety follow-up (approximately up to 15 months after randomization).
To assess participant-reported global health status (GHS)/quality of life (QoL) in participants treated with Dato-DXd + rilvegostomig (Arm 1) as compared with SoC (Arm 3).
大体时间：D1C1, then every 3w (21d cycles) until end of treatment (~12m from randomization); thereafter every 6w after treatment discontinuation until recurrence, start of subsequent therapy, or study discontinuation, up to 18m post-treatment.
Proportion of participants with maintained or improved GHS/QoL as measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) GHS/QoL subscale (EORTC IL6) at each time point.
D1C1, then every 3w (21d cycles) until end of treatment (~12m from randomization); thereafter every 6w after treatment discontinuation until recurrence, start of subsequent therapy, or study discontinuation, up to 18m post-treatment.
Safety of adjuvant Dato-DXd in combination with rilvegostomig as compared with Dato-DXd monotherapy and SoC.
大体时间：From randomization through the end of treatment (approximately up to 12 months after randomization) and through the end of safety follow-up (approximately up to 15 months after randomization).
Safety will be evaluated in terms of AEs.
From randomization through the end of treatment (approximately up to 12 months after randomization) and through the end of safety follow-up (approximately up to 15 months after randomization).

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

AstraZeneca

合作者

Daiichi Sankyo

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)

2026年7月16日

初级完成 (估计的)

2030年9月11日

研究完成 (估计的)

2032年11月23日

研究注册日期

首次提交

2026年6月10日

首先提交符合 QC 标准的

2026年7月17日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年7月17日

最后验证

2026年7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

  • D763TC00001

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

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 共享时间框架

Study start to completion date

IPD 共享访问标准

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 共享支持信息类型

  • 国际碳纤维联合会

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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