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 (TROPION-Urothelial04).

Condition studied

High-risk muscle invasive urothelial carcinoma (MIUC) originating in bladder or upper tract (renal pelvis/ureter).

Investigational medicinal product(s)

Eligibility

Primary endpoint

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.

Endpoint detail

Overall survival (OS) is defined as the time from randomisation until the date of death due to any cause., Disease-free survival (DFS) by Investigator and Blinded Independent central review (BICR): 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 from any cause., Disease Specific Survival (DSS) is defined as time from randomisation until death due to disease (urothelial cancer)., Non-Urothelial Tract Recurrence-Free Survival (NUTRFS) is defined as time from randomisation until first local nonurothelial tract or distant recurrence or death due to any cause., Distant Metastasis-Free Survival (DMFS) is defined as time from randomisation until first distant recurrence (non-local) or death due to any cause., Pharmacokinetics of Dato-DXd, DXd and rilvegostomig., Immunogenicity of Dato-DXd and rilvegostomig., Clinical Outcome Assessments: The secondary PRO endpoint is the 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., Safety and tolerability.