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

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

See Plan Description

See Plan Description