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Clinical Trials List

Protocol NumberD763TC00001
NCT Number(ClinicalTrials.gov Identfier)NCT07720284
Not yet recruiting

2026-06-01 - 2032-12-31

Phase III

Not yet recruiting1

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

  • Trial Applicant

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/10

Investigators and Locations

Principal Investigator 羅浩倫 Division of Urology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

Principal Investigator Yi-Hsiu Huang Division of Urology
Taipei Veterans General Hospital

Co-Principal Investigator

Principal Investigator Po-Jung Su Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

Principal Investigator Tzu-Ping Lin Division of Urology
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

Principal Investigator Wen-Jeng Wu Division of Urology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

Principal Investigator Yuh-Shyan Tsai
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

High-risk Muscle Invasive Urothelial Carcinoma

Objectives

本試驗目的是在根除性手術切除時患有高風險殘餘疾病的受試者中，評估 Dato-DXd + rilvegostomig 作為肌肉侵犯性泌尿上皮癌 (MIUC) 輔助治療相較於標準照護 (SoC) 療法的療效和安全性。

Test Drug

凍晶注射劑
注射劑
注射劑
注射劑

Active Ingredient

Datopotamab Deruxtecan
Rilvegostomig (AZD2936)
Nivolumab
Durvalumab

Dosage Form

243
270
270
270

Dosage

100 mg/Vial
750 mg/Vial (50 mg/mL)
120 mg/Vial (10 mg/mL)
500 mg/Vial (50 mg/mL)

Endpoints

透過評估在根除性切除時患有高風險殘餘疾病的肌肉侵犯性泌尿上皮癌 (MIUC) 受試者的無疾病存活期 (DFS) (依據試驗主持人評估)，證明 Dato-DXd + rilvegostomig (第 1 組) 相較於標準照護 (SoC) (第 3 組) 的優越性。

Inclution Criteria

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

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.

The Estimated Number of Participants

  • Taiwan

    32 participants

  • Global

    915 participants

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