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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Urothelial Cancer

Treatments: Drug: Gemcitabine; Drug: Carboplatin; Drug: Cisplatin; Drug: Iza-bren

Study type: Interventional

Funder types: Industry

Identifiers

NCT07106762

CA244-0012

WHO

EU CTR (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 470 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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470 participants in 5 patient groups

Arm A

Experimental group

Treatment:

Drug: Iza-bren

Arm B

Experimental group

Treatment:

Drug: Iza-bren

Arm C

Active Comparator group

Treatment:

Drug: Cisplatin

Drug: Carboplatin

Drug: Gemcitabine

Arm D

Experimental group

Treatment:

Drug: Iza-bren

Arm E

Active Comparator group

Treatment:

Drug: Cisplatin

Drug: Carboplatin

Drug: Gemcitabine