Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma

This is a global, multicenter, randomized, open-label, Phase 2/3 study of Dato-DXd plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participants with la/mUC who progressed during or after EV plus pembrolizumab combination treatment. This trial will start with part A, Phase 2. During part A, Phase 2, preliminary efficacy and safety will be assessed, and the recommended Phase 3 dose (RP3D) will be identified when the data allow sufficient assessment of activity, safety, and tolerability. The Phase 3 part will start contingent upon the assessment in the Phase 2 p

Trial Details

NCT ID
NCT07129993
Phase
PHASE2 / PHASE3
Sponsor
Daiichi Sankyo
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • Dato-DXd
  • Carboplatin
  • Cisplatin
  • Gemcitabine
Locations (sample)
  • Fullerton, California, United States|33.87029,-117.92534
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Orange City, Florida, United States|28.94888,-81.29867
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Effingham, Illinois, United States|39.12004,-88.54338

Key Eligibility Criteria

  • Adult ≥18 years at the time the ICF is signed (if the legal age of consent is \> 18 years old, then follow the local regulatory requirements).
  • Histologically or cytologically confirmed unresectable locally advanced (T4b, any N; or any T, N 2-3) or metastatic (any T, any N, M1) urothelial c…
  • Participants with urothelial carcinoma (transitional cell) with squamous differentiation or mixed cell types are eligible if the histology is predo…
  • Note 1: Urachal, small cell, and adenocarcinoma histology is not permitted.

For full eligibility, visit ClinicalTrials.gov.

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