Trial comparing treatments for Urothelial Cancer
Official title Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
ClinicalTrials.gov ID: NCT07106762
What this study is testing
What is Iza-bren?
Iza-bren is an investigational medicine, being studied as a potential treatment for urothelial cancer.
Also referred to as BMS-986507, BL-B01D1.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to compare how well izalontamab brengitecan works and is tolerated compared to platinum chemotherapy in patients whose metastatic urothelial cancer has progressed after immunotherapy.
- Who it's for
- Adults with metastatic urothelial (bladder) cancer whose disease has gotten worse after receiving immunotherapy.
- What's involved
- Participants will receive either izalontamab brengitecan or platinum‑based chemotherapy and will have regular clinic visits for treatment, safety checks, and scans.
- Time commitment
- The trial lasts several months, with treatment cycles given every few weeks and periodic follow‑up visits.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- 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.
You likely can't 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Palo Alto, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Santa Rosa, California, United States
- Denver, Colorado, United States
- Edwards, Colorado, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Detroit, Michigan, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Mayfield Heights, Ohio, United States
- Nashville, Tennessee, United States
- Abilene, Texas, United States
- Murray, Utah, United States
- St. George, Utah, United States
- Charlottesville, Virginia, United States
+ 89 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Palo Alto, California, United States; Sacramento, California, United States; San Francisco, California, United States; Santa Rosa, California, United States; Denver, Colorado, United States; Edwards, Colorado, United States and 103 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.