Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
Study Phase: Phase 2/Phase 3
Recruitment Status: Recruiting
Start Date: September 30, 2025
End Date: November 18, 2033
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
855-907-3286
First line of the email MUST contain NCT # and Site #.
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.
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Conditions:
- Urinary Bladder Neoplasms