Who is eligible for clinical trial NCT07720284?

Participants must meet protocol criteria for High-risk Muscle Invasive Urothelial Carcinoma. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07720284 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC (NCT07720284)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: AstraZeneca

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (21 items).

Location: Research Site — Hot Springs, Arkansas

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗

An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC (NCT07720284)

🩺 Plain-English Summary (8th-Grade Level)

📋 "Do I Qualify?" — 1-Minute Self Screener

Usually NOT eligible if any of the following apply:

📍 All Participating Trial Locations (160 Sites)

💰 Cost, Insurance & Patient Rights