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

NCT07106762

RecruitingPhase 2, Phase 3

Sponsor: Bristol-Myers Squibb

Conditions: Urothelial Cancer

Interventions: Iza-bren, Cisplatin, Gemcitabine, Carboplatin

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (163)

Gilbert, Arizona, United States
Fullerton, California, United States
Palo Alto, California, United States
Sacramento, California, United States
Sacramento, California, United States
San Francisco, California, United States
Santa Rosa, California, United States
Denver, Colorado, United States
Dillon, Colorado, United States
Edwards, Colorado, United States
Washington D.C., District of Columbia, United States
Miami, Florida, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Buffalo, New York, United States
New York, New York, United States
New York, New York, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Mayfield Heights, Ohio, United States
Portland, Oregon, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Abilene, Texas, United States
Austin, Texas, United States
Murray, Utah, United States
St. George, Utah, United States
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