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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)

17 luglio 2026 aggiornato da: 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

Panoramica dello studio

Stato

Reclutamento

Condizioni

High-risk Muscle Invasive Urothelial Carcinoma

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

915

Fase

Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: AstraZeneca Clinical Study Information Center
Numero di telefono: 1-877-240-9479
Email: information.center@astrazeneca.com

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Adulto
Adulto più anziano

Accetta volontari sani

Descrizione

Inclusion criteria:

Participant must be > 18 years of age at the time of signing the ICF.
Histologically confirmed MIUC of the bladder or upper tract.
Completed R0 radical resection 28 to 120 days before randomisation, with negative margins and no residual or metastatic disease.
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
No evidence of disease at screening,
ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to randomisation.
Minimum life expectancy of > 12 weeks at time of screening.
An archival surgical tumour sample must be available pre-randomisation for central testing.
Adequate organ and bone marrow function within 28 days before randomisation.

Exclusion criteria:

Any tumour with predominant or pure high grade neuroendocrine carcinoma component.
Partial cystectomy in the setting of bladder cancer primary tumour or partial nephrectomy.
Any adjuvant systemic or radiation therapy post-surgery for urothelial carcinoma.
Severe or uncontrolled systemic diseases, history of organ transplant or allogeneic stem cell transplant, or psychological disorders/social situations, and/or substance abuse.
History of clinically significant corneal disease.
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.
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.
Active or uncontrolled hepatitis B or C virus infection.
Known HIV infection that is not well controlled.
Any other active or uncontrolled infection including tuberculosis requiring systemic treatment that has not resolved by the time of randomisation.
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.
Has clinically severe pulmonary function compromise.
Mean resting corrected QTcF > 470 ms regardless of gender, obtained from triplicate 12-lead ECGs performed at screening
Uncontrolled or significant cardiac conditions.
Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment in the past 5 years.
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.
Current or prior use of immunosuppressive medication within 14 days prior to treatment assignment/randomisation.
Known history of severe hypersensitivity reactions to any study drug
Not eligible to receive at least one of SoC according to local regulations/approvals.
Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Separare

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: 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.	Droga: 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. Altri nomi: Datopotamab deruxtecan (Dato-DXd, DS-1062a) Droga: 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. Altri nomi: AZD2936
Sperimentale: 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.	Droga: 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. Altri nomi: Datopotamab deruxtecan (Dato-DXd, DS-1062a)
Comparatore attivo: 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.	Droga: 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. Altri nomi: Imfinzi, MEDI4736 Droga: 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. Altri nomi: OPDIVO®, BMS-936558 Droga: 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. Altri nomi: Keytruda, MK-3475 Droga: 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. Altri nomi: Padcev®, ASG-22CE, AGS-22M6E

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
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). Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
To demonstrate the superiority of Dato-DXd + rilvegostomig (Arm 1) relative to SoC (Arm 3) by assessment of OS (Overall survival). Lasso di tempo: 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). Lasso di tempo: 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. Lasso di tempo: 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. Lasso di tempo: 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. Lasso di tempo: 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). Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato	Misura Descrizione	Lasso di tempo
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. Lasso di tempo: 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). Lasso di tempo: 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). Lasso di tempo: 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. Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Collaboratori

Daiichi Sankyo

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 luglio 2026

Completamento primario (Stimato)

11 settembre 2030

Completamento dello studio (Stimato)

23 novembre 2032

Date di iscrizione allo studio

Primo inviato

10 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 luglio 2026

Primo Inserito (Effettivo)

22 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

D763TC00001

Piano per i dati dei singoli partecipanti (IPD)

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SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

Study start to completion date

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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)

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

Panoramica dello studio

Stato

Condizioni

Intervento / Trattamento

Tipo di studio

Iscrizione (Stimato)

Fase

Contatti e Sedi

Contatto studio

Luoghi di studio

Criteri di partecipazione

Criteri di ammissibilità

Età idonea allo studio

Accetta volontari sani

Descrizione

Piano di studio

Come è strutturato lo studio?

Dettagli di progettazione

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm

Intervento / Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Misure di risultato secondarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Altre misure di risultato

Misura del risultato

Misura Descrizione

Lasso di tempo

Collaboratori e investigatori

Sponsor

Collaboratori

Studiare le date dei record

Studia le date principali

Inizio studio (Effettivo)

Completamento primario (Stimato)

Completamento dello studio (Stimato)

Date di iscrizione allo studio

Primo inviato

Primo inviato che soddisfa i criteri di controllo qualità

Primo Inserito (Effettivo)

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo verificato

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

Periodo di condivisione IPD

Criteri di accesso alla condivisione IPD

Tipo di informazioni di supporto alla condivisione IPD

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti