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Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy

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NCT07106762 · readout in 891 d

Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.

Phase
Phase 2/3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
470estimated
Sites
163
Countries
Argentina, Australia, Austria +19

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2025-09-30actualWhen the study began enrolling
Primary completion2029-01-26estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2033-11-18estimatedThe whole study's end, after follow-up
First posted2025-08-06actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-29actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Urothelial Cancer

Interventions

  • Drug: Iza-bren — also filed as BMS-986507, BL-B01D1, Izalontamab brengitecan
  • Drug: Cisplatin
  • Drug: Gemcitabine
  • Drug: Carboplatin

Primary outcomes

what the primary-completion date above is the date OF
Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507
measured Approximately 3 months
Phase 3: Progression-Free Survival (PFS)
measured Up to 5 years
Phase 3: Overall Survival (OS)
measured Up to 5 years

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