What is Izalontamab Brengitecan studying for metastatic urothelial cancer?

Izalontamab Brengitecan is being studied as a treatment for metastatic urothelial cancer that has progressed after immunotherapy. Researchers are comparing it to platinum-based chemotherapy to evaluate its effects on survival and disease progression. The trial is sponsored by Bristol-Myers Squibb to help find new options for patients facing advanced urothelial cancer.

Who may be eligible for this urothelial cancer clinical trial?

Adults aged 18 or older with advanced urothelial carcinoma who have previously received Anti-PD-(L)1 immunotherapy may be eligible. Participants must be able to receive platinum-based chemotherapy and have measurable disease. People who recently had platinum chemotherapy within 12 months or more than two prior treatment regimens are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this urothelial cancer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional expenses.

Actively Recruiting

Phase 2

Phase 3

Age: 18Years +

All Genders

ID07106762

Randomized Phase 23 Study Comparing Izalontamab Brengitecan and Platinum-based Chemotherapy in Adults with Metastatic Urothelial Cancer After Immunotherapy Treatment

Led by Bristol-Myers Squibb · Updated on 2026-07-29

470

Participants Needed

163

Research Sites

251 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating Izalontamab Brengitecan compared to platinum-based chemotherapy for patients with metastatic urothelial cancer that has progressed after immunotherapy. This Phase 23 randomized trial aims to find the best dose and assess progression-free survival and overall survival over up to five years. Participants must have confirmed advanced urothelial carcinoma and have experience with Anti-PD-L1 therapy. Participants will be assigned to receive either Izalontamab Brengitecan or platinum-based chemotherapy such as Cisplatin, Gemcitabine, or Carboplatin at specified doses on defined days. The study includes several arms and evaluates treatment effects in parallel groups. The Phase 2 portion focuses on determining the recommended Phase 3 dose, while Phase 3 assesses efficacy outcomes over several years. Throughout the trial, participants will undergo regular assessments including tumor measurement by RECIST v1.1, performance status evaluations, antibody-drug conjugate concentrations, and quality of life measurements. Outcome measures include progression-free survival, overall survival, objective response, duration of response, and time to response. The study involves long-term follow-up lasting up to five years to monitor treatment effects and safety.

CONDITIONS

Brief Title

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

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

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.
Participants treated only in the peri-operative setting must have relapsed within 12 months of last treatment dose.
Participants must have at least 1 measurable lesion per RECIST v1.1.
Participants must have ECOG Performance Status 0-1.

You will not qualify if you...

Participants must not have had platinum-based chemotherapy within the last 12 months.
Participants must not have received more than 2 prior treatment regimens.
Participants must not have prior antibody-drug conjugate 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.

Research Team

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

First line of the email MUST contain NCT # and Site #.

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Randomized Phase 23 Study Comparing Izalontamab Brengitecan and Platinum-based Chemotherapy in Adults with Metastatic Urothelial Cancer After Immunotherapy Treatment

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria