Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
Recruiting now Phase 2/3 NCT07106762
Run by Bristol-Myers Squibb · for 18 and older · All sexes
What this study is about
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 join (things the study team will check)
✅ You may be able to join if…
- 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.
🚫 You may not be able to join if…
- 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.
Where this trial is running
- Local Institution - 0167, Gilbert, Arizona, United States
- Local Institution - 0162, Fullerton, California, United States
- Palo Alto Center-Palo Alto Medical Foundation Research Institute, Palo Alto, California, United States
- Sutter Health - Sutter Institute for Medical Research, Sacramento, California, United States
- University of California Davis (UC Davis) Comprehensive Cancer Center, Sacramento, California, United States
- Pacific Hematology Oncology Associates, San Francisco, California, United States
- Sutter Santa Rosa, Santa Rosa, California, United States
- Rocky Mountain Cancer Centers, LLP, Denver, Colorado, United States
- Local Institution - 0245, Dillon, Colorado, United States
- Shaw Cancer Center, Edwards, Colorado, United States
- Sibley Memorial Hospital, Washington D.C., District of Columbia, United States
- Local Institution - 0247, Miami, Florida, United States
+ 151 more sites.
Who to contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07106762.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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