Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
Phase 2/3 – combined trial
Conditions:
Urothelial Cancer
Sponsor: Bristol-Myers Squibb
trial.available_in:
БГ
Overview
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
Who can participate
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.