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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

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

IZABRIGHT-Bladder01: A Randomized, Open-label, Phase 2/3 Trial of Izalontamab Brengitecan Versus Platinum-based Chemotherapy for Metastatic Urothelial Cancer in Participants With Disease Progression on or After an Immunotherapy-based Treatment

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - Participants must have diagnosed by tissue sample (biopsy-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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Iza-bren

Specified dose on specified days

DRUG

Cisplatin

Specified dose on specified days

DRUG

Gemcitabine

Specified dose on specified days

DRUG

Carboplatin

Specified dose on specified days

Locations (20)

Local Institution - 0167
Gilbert, Arizona, United States
Local Institution - 0162
Fullerton, California, United States
Local Institution - 0252
Palo Alto, California, United States
Local Institution - 0163
Sacramento, California, United States
Local Institution - 0139
Sacramento, California, United States
Local Institution - 0251
San Francisco, California, United States
Local Institution - 0254
Santa Rosa, California, United States
Local Institution - 0245
Dillon, Colorado, United States
Shaw Cancer Center
Edwards, Colorado, United States
Local Institution - 0250
Washington D.C., District of Columbia, United States
Local Institution - 0247
Miami, Florida, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Local Institution - 0232
Baltimore, Maryland, United States
Local Institution - 0195
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Local Institution - 0248
Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States