Izalontamab Brengitecan versus Platinum Chemotherapy for Advanced Urothelial Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2/3 study compares izalontamab brengitecan with investigator-choice platinum-based chemotherapy (cisplatin or carboplatin with gemcitabine) in patients with advanced or metastatic urothelial carcinoma who have progressed on prior anti–PD-(L)1 therapy. Eligible participants must have histologic confirmation, at least one measurable lesion per RECIST v1.1, and ECOG performance status 0–1, with limited prior lines of therapy and no recent platinum exposure within 12 months. Participants will be assigned to one of the treatment arms and followed for tumor response, progression-free survival, and safety outcomes. The trial is sponsored by Bristol-Myers Squibb and is open at selected U.S. clinical sites in Arizona and California.

Why it matters

Who can join: the full rules

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.

Where it's running

• Palo Alto Center-Palo Alto Medical Foundation Research Institute
  Palo Alto, California, United States Recruiting
• Sutter Health - Sutter Institute for Medical Research
  Sacramento, California, United States Recruiting
• University of California Davis (UC Davis) Comprehensive Cancer Center
  Sacramento, California, United States Recruiting
• Pacific Hematology Oncology Associates
  San Francisco, California, United States Recruiting
• Sutter Santa Rosa
  Santa Rosa, California, United States Recruiting
• Rocky Mountain Cancer Centers, LLP
  Denver, Colorado, United States Recruiting

+113 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.