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

Recruiting now · Phase 2/Phase 3

Conditions studied: Urothelial Cancer

In brief

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

Key facts

Study ID

NCT07106762

Run by

Bristol-Myers Squibb

People needed

470

Starts

2025-09-30

Expected to finish

2033-11-18

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• St George Regional Hospital Cancer Center — St. George, Utah, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Intermountain Medical Center — Murray, Utah, United States (enrolling)
• University of California Davis (UC Davis) Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
• University of Virginia Health System — Charlottesville, Virginia, United States (enrolling)
• Palo Alto Center-Palo Alto Medical Foundation Research Institute — Palo Alto, California, United States (enrolling)
• Texas Oncology - West Texas — Abilene, Texas, United States (enrolling)
• Sutter Health - Sutter Institute for Medical Research — Sacramento, California, United States (enrolling)
• Shaw Cancer Center — Edwards, Colorado, United States (enrolling)
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Pacific Hematology Oncology Associates — San Francisco, California, United States (enrolling)
• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States (enrolling)
• Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
• Sutter Santa Rosa — Santa Rosa, California, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Fairview Hospital — Cleveland, Ohio, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• The James Outpatient Care West Campus — Columbus, Ohio, United States (enrolling)
• Cleveland Clinic - Hillcrest Hospital — Mayfield Heights, Ohio, United States (enrolling)
• Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• University of Washington Medical Center - Montlake — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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