이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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)

2026년 7월 17일 업데이트: 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

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

915

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 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.
다른 이름들:
  • Datopotamab deruxtecan
  • (Dato-DXd, DS-1062a)
의약품: 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.
다른 이름들:
  • AZD2936
실험적: 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.
의약품: 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.
다른 이름들:
  • Datopotamab deruxtecan
  • (Dato-DXd, DS-1062a)
활성 비교기: 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.
의약품: 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.
다른 이름들:
  • 임핀지, MEDI4736
의약품: 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.
다른 이름들:
  • OPDIVO®, BMS-936558
의약품: 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.
다른 이름들:
  • 키트루다, MK-3475
의약품: 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.

다른 이름들:
  • Padcev®, ASG-22CE, AGS-22M6E

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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).
기간: 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).

2차 결과 측정

결과 측정
측정값 설명
기간
To demonstrate the superiority of Dato-DXd + rilvegostomig (Arm 1) relative to SoC (Arm 3) by assessment of OS (Overall survival).
기간: 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).
기간: 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.
기간: 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.
기간: 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.
기간: 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).
기간: 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.

기타 결과 측정

결과 측정
측정값 설명
기간
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.
기간: 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).
기간: 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).
기간: 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.
기간: 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).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

협력자

Daiichi Sankyo

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 16일

기본 완료 (추정된)

2030년 9월 11일

연구 완료 (추정된)

2032년 11월 23일

연구 등록 날짜

최초 제출

2026년 6월 10일

QC 기준을 충족하는 최초 제출

2026년 7월 17일

처음 게시됨 (실제)

2026년 7월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 17일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • D763TC00001

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

Study start to completion date

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다