RecruitingUrothelial Cancer

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

Eligible age

18+ yrs

Accepts

All genders

Locations

17 states

Healthy volunteers

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About this study

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

Sponsor: Bristol-Myers Squibb

You may qualify if…

✓ Participants must have histologically confirmed advanced urothelial carcinoma.
✓ Participants must be eligible to receive platinum-based chemotherapy.
✓ Participants must be Anti-PD-(L)1-experienced (in locally advanced or metastatic setting), either in combination with or sequential to another systemic therapy.
✓ Participants treated only in the peri-operative setting must have relapsed within 12 months of the last dose of the treatment.
✓ Participants must have ≥ 1 measurable lesion per RECIST v1.1.
✓ Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

You may not qualify if…

✕ Participants must not have platinum-based chemotherapy exposure within 12 months.
✕ Participants must not have received \>2 prior regimens irrespective of the setting.
✕ Participants must not have prior ADC therapy targeting EGFR or HER3.
✕ Participants must not have prior therapy with topoisomerase 1 inhibitor.
✕ Participants must not have active, untreated brain metastases.
✕ Other protocol-defined inclusion/exclusion criteria apply.