Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
Sponsor: Bristol-Myers Squibb
Sponsor score: 60
ClinicalTrials ID:NCT07106762
This Phase 2/3 trial evaluates Iza-bren against platinum-based chemotherapy in patients with advanced urothelial carcinoma post-immunotherapy. Eligible participants must have confirmed advanced disease, prior Anti-PD-(L)1 therapy, and measurable lesions. Interventions include Iza-bren, Cisplatin, Gemcitabine, and Carboplatin, with specified dosing schedules.
Patient Parameters
| Parameter | Options |
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Program Overview
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0167 | 85234 | Gilbert | Arizona |
| Local Institution - 0162 | 92835 | Fullerton | California |
| Local Institution - 0163 | 95816 | Sacramento | California |
| Local Institution - 0139 | 95817 | Sacramento | California |
| Local Institution - 0245 | 80435 | Dillon | Colorado |
| Local Institution - 0191 | 81632 | Edwards | Colorado |
| Local Institution - 0250 | 20016 | Washington D.C. | District of Columbia |
| Local Institution - 0247 | 33176 | Miami | Florida |
| Local Institution - 0193 | 40536 | Lexington | Kentucky |
| Local Institution - 0232 | 21287 | Baltimore | Maryland |
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