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

StatusRecruiting
PhasePhase 2/3
Started2025-09-26
View on ClinicalTrials.gov ↗

Amendment history

2026-08-18
Study Status, Arms and Interventions, Eligibility v23
Eligibility criteria-1,083 characters
[...] nts). Histologically or cytologically confirmed unresectable or locally advanced (T4b, any N; or any T, N 2-3) or metastati [...] es are eligible if the histology is predominantly urothelial. > Noteas 1:specified Urachal, small cell, and adenocarcinoma histology is not permitted. Note 2: Participants with la/mUC and a history of nonclinically active prostate cancer are allowed intoin the trial if: Participant does not have radiological metastasis of a proven prostate cancerprotocol. Participant with nonmetastatic prostate cancer do not have rising PSA (as determined using local testing by a validated [...] [...]
2026-07-24
Study Status, Contacts/Locations v22
Study sitesdetails revised at 1 of 100 sites
2026-07-01
Study Status, Contacts/Locations v21
Study sitesdetails revised at 4 of 100 sites
2026-06-12
Study Status, Contacts/Locations v20
Study sites99→100
2026-06-05
Study Status, Eligibility, Contacts/Locations v19
Study sites98→99
Eligibility criteria+1,198 characters
[...] are eligible if the histology is predominantly urothelial. > Note 1: Urachal, small cell, and adenocarcinoma histology is [...] by a validated or approved test method) defined as follows: • Increase in PSA within 2 consecutive measurements separated [...] n deprivation therapy for the treatment of prostate cancer. •Note 3: Participant with MIBC (T2-T4aN0M0 or T1-T4aN1M0) who received EV (or other agents with a vedotin payload) plus pembrolizumab (or other PD-1/PD-L1 inhibitors) as neoadjuvant/adjuvant therapy and progressed during treatment or within 12 months of treatment completion may be considered for [...] [...]
2026-05-12
Study Status, Contacts/Locations v18
Trial sites expanded: 80 → 98 locations
2026-05-11
Study Status, Contacts/Locations v17
Study sites79→80
2026-03-17
Study Status, Contacts/Locations v16
Study sites76→79
2026-03-04
Study Status, Contacts/Locations v15
Study sites75→76
2026-02-26
Study Status, Contacts/Locations v14
Study sites70→75
2026-02-19
Study Status, Contacts/Locations v13
Study sites66→70
2026-02-10
Study Status, Contacts/Locations v12
Study sitesdetails revised at 1 of 66 sites
2026-02-03
Study Status, Contacts/Locations v11
Study sites56→66
2026-01-28
Study Status, Contacts/Locations v10
Study sites52→56
2026-01-16
Study Status, Contacts/Locations v9
Study sites46→52
2026-01-14
Study Status, Contacts/Locations v8
Study sites40→46
2025-12-23
Study Status, Contacts/Locations v7
Study sites22→40
2025-12-04
Study Status, Contacts/Locations v6
Study sites20→22
2025-11-21
Study Status, Contacts/Locations v5
Study sites13→20
2025-11-05
Study Status, Contacts/Locations v4
Study sites6→13
2025-10-22
Study Status, Contacts/Locations v3
Study sites5→6
2025-10-10
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sites3→5
2025-09-22
Study Status, Contacts/Locations v1
Primary completion date2030-02-12→2029-06-01
Completion date2030-02-16→2030-01-22
Study sites0→3
2025-08-12
Original filing
Daiichi Sankyo
69 trials monitored
See 8 trials at risk
Bladder Cancer
1,018 trials monitored
See 64 trials at risk
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 part, taking into consideration the totality of information.
Trial Details
NCT Number NCT07129993
Lead Sponsor Daiichi Sankyo
Collaborators: AstraZeneca
Conditions Urothelial Cancer, Bladder Cancer
Enrollment 630 participants
Start Date 2025-09-26
Primary Completion 2029-06-01 (estimated)
Study Completion 2030-01-22 (estimated)
Updated on ClinicalTrials.gov 2026-08-20