Study of Dato-DXd + Rilvegostomig for High-Risk Bladder Cancer
This study is testing a new combination of medicines, Dato-DXd and Rilvegostomig, against standard treatments (Durvalumab, Nivolumab, or Pembrolizumab) for adults with high-risk muscle-invasive urothelial carcinoma (a type of bladder cancer). This is for patients who have already had surgery to remove their cancer. The main goal is to see if Dato-DXd + Rilvegostomig can help people live longer without their cancer coming back. To join, you must be over 18, have had your bladder cancer surgically removed with no remaining cancer, and have a high risk of the cancer returning. The study is open-label, meaning you and your doctors will know which treatment you are receiving.
- Study design
- This is an open-label study comparing Dato-DXd + Rilvegostomig to standard treatments in approximately 915 participants. The study aims to show if the new combination is better than current standard care.
- What's involved
- Treatment could last up to about 12 months, with visits every 3 weeks for the new combination, or every 2-4 weeks for standard treatments.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for disease recurrence or death for up to 49 months after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC
At a glance
Conditions
Where it's being run
160 sites across 32 statesWho to contact
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What this trial measures
- 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).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.