OncoMatch/Clinical Trials/NCT07720284
An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC
Is NCT07720284 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments for high-risk muscle invasive urothelial carcinoma.
Treatment: Dato-DXd · Rilvegostomig · Durvalumab · Nivolumab · Pembrolizumab · Enfortumab vedotin — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage PT3-PT4AN0, ANY PT WITH PN+, YPT2-YPT4A, ANY YPT WITH YPN+
Pathologic evidence of urothelial carcinoma at high-risk of recurrence and 1. not received neoadjuvant therapy and has pT3-pT4aN0, or any pT with pN+ stage 2. completed neoadjuvant treatment and has ypT2-ypT4a, or any ypT with ypN+ stage
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to randomisation
Prior therapy
Cannot have received: adjuvant systemic therapy for urothelial carcinoma
Any adjuvant systemic or radiation therapy post-surgery for urothelial carcinoma
Cannot have received: adjuvant radiation therapy for urothelial carcinoma
Any adjuvant systemic or radiation therapy post-surgery for urothelial carcinoma
Cannot have received: TROP2-directed therapy
Prior exposure to TROP2-directed therapies
Cannot have received: antibody-drug conjugate with deruxtecan
Prior exposure to other ADCs with deruxtecan
Cannot have received: therapeutic anti-cancer vaccine
Prior exposure to therapeutic anti-cancer vaccines
Cannot have received: anti-TIGIT therapy
Prior exposure to anti-TIGIT therapy
Cannot have received: anti-cancer therapy targeting immune-regulatory receptors or mechanisms
Prior exposure to any other anti-cancer therapy targeting immune-regulatory receptors or mechanisms
Lab requirements
Blood counts
adequate organ and bone marrow function within 28 days before randomisation
Kidney function
Liver function
Adequate organ and bone marrow function within 28 days before randomisation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Hot Springs, Arkansas
- Research Site · Little Rock, Arkansas
- Research Site · Little Rock, Arkansas
- Research Site · San Francisco, California
- Research Site · Chicago, Illinois
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07720284 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior adjuvant systemic therapy for urothelial carcinoma, adjuvant radiation therapy for urothelial carcinoma, TROP2-directed therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage PT3-PT4AN0 or ANY PT WITH PN+ or YPT2-YPT4A or ANY YPT WITH YPN+ is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages