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 juillet 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
915
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: AstraZeneca Clinical Study Information Center
- Numéro de téléphone: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Lieux d'étude
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Bochum, Allemagne, 44791
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Bonn, Allemagne, 53127
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Duisburg, Allemagne, 47169
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
- not received neoadjuvant therapy and has pT3-pT4aN0, or any pT with pN+ stage
- 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
|
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.
Autres noms:
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.
Autres noms:
|
|
Expérimental: 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.
|
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.
Autres noms:
|
|
Comparateur actif: 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. |
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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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).
Délai: 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).
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
To demonstrate the superiority of Dato-DXd + rilvegostomig (Arm 1) relative to SoC (Arm 3) by assessment of OS (Overall survival).
Délai: 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).
Délai: 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.
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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).
|
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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.
Délai: 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.
Délai: 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.
Délai: 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).
|
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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).
Délai: 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.
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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.
Délai: 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.
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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).
|
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To investigate the immunogenicity of Dato-DXd and rilvegostomig in Dato-DXd + rilvegostomig combination therapy (Arm 1) and Dato-DXd monotherapy (Arm 2).
Délai: 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).
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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).
|
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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).
Délai: 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.
|
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Safety of adjuvant Dato-DXd in combination with rilvegostomig as compared with Dato-DXd monotherapy and SoC.
Délai: 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).
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Safety will be evaluated in terms of AEs.
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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).
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
16 juillet 2026
Achèvement primaire (Estimé)
11 septembre 2030
Achèvement de l'étude (Estimé)
23 novembre 2032
Dates d'inscription aux études
Première soumission
10 juin 2026
Première soumission répondant aux critères de contrôle qualité
17 juillet 2026
Première publication (Réel)
22 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies urogénitales masculines
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Tumeurs par type histologique
- Tumeurs, glandulaires et épithéliales
- Tumeurs urologiques
- Maladies de la vessie urinaire
- Carcinome
- Tumeurs de la vessie urinaire
- Carcinome à cellules transitionnelles
- Acides aminés, peptides et protéines
- Protéines
- Anticorps, monoclonal, humanisé
- Anticorps, monoclonal
- Anticorps
- Immunoglobulines
- Immunoprotéines
- Protéines sanguines
- Globulines sériques
- Globulines
- Nivolumab
- pembrolizumab
- durvalumab
- enfortumab vedotin
Autres numéros d'identification d'étude
- D763TC00001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Délai de partage IPD
Study start to completion date
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .