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

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

Trial Details

NCT ID
NCT07720284
Phase
PHASE3
Sponsor
AstraZeneca
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • Dato-DXd
  • Rilvegostomig
  • Durvalumab
  • Nivolumab
  • Pembrolizumab
  • Enfortumab vedotin
Locations (sample)
  • Hot Springs, Arkansas, United States|34.5037,-93.05518
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • San Francisco, California, United States|37.77493,-122.41942
  • Chicago, Illinois, United States|41.85003,-87.65005

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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