Last updated 12 days ago

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

470 patients around the world

Available in Brazil, Argentina, United States

Bristol-Myers Squibb

470Patients around the world

This study is for people with

Urothelial cancer

From 18 Years

All Gender

: 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.

: 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.

SponsorBristol-Myers Squibb

Study typeInterventional

Conditions

Urothelial cancer

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07106762