RecruitingPHASE2, PHASE3INTERVENTIONAL

Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy

This research study is looking into a new treatment called Izalontamab Brengitecan (Iza-bren) for people with advanced bladder cancer (urothelial cancer) that has spread. Participants in this study will either receive Iza-bren or standard chemotherapy, such as cisplatin or gemcitabine. The study is for those whose cancer has grown worse during or after immunotherapy. Researchers want to compare the new medicine with current treatments to see if it's more effective, has fewer side effects, or both. This is a Phase 2/3 study, meaning it’s carefully testing the new drug’s effectiveness and safety in a larger group of people, building on earlier research.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

470

Start

30 Sep 2025

Estimated completion

18 Nov 2033

Urothelial Cancer

What is this study about?

This study is for individuals diagnosed with advanced urothelial cancer, which is a type of cancer that commonly starts in the bladder or urinary system but can also spread to other areas of the body. The trial is specifically for patients whose cancer has started to progress, meaning it's growing or spreading, even after they have received a type of treatment called immunotherapy. Immunotherapy helps your body's own immune system fight cancer. The researchers want to find new and more effective ways to treat this type of cancer when standard treatments haven't fully worked or have stopped being effective.

The main goal of this study is to compare a new medicine called Izalontamab Brengitecan (which we'll call Iza-bren for short) with the current standard chemotherapy treatments. These standard treatments usually involve drugs like cisplatin, gemcitabine, or carboplatin. By comparing Iza-bren to these established treatments, doctors hope to learn if Iza-bren is better at controlling the cancer, helps people live longer, or has different side effects.

This kind of research is important because it helps develop new and improved treatment options for people living with cancer. Finding new and more effective treatments means better outcomes and a better quality of life for patients. The study is in its Phase 2/3 stage, which means it’s already shown some promise in earlier, smaller studies and is now being tested in a larger group of people to confirm its benefits and understand its safety more fully.

Key takeaways

This study compares a new drug (Iza-bren) with standard chemotherapy for advanced bladder cancer.
It's for people whose cancer has progressed after receiving immunotherapy.
Participants will receive either Iza-bren or standard chemotherapy, decided by chance.
The study aims to find more effective treatments for advanced urothelial cancer.
Close monitoring for effectiveness and side effects is part of participation.

Who may be eligible?

To join this study, you must have been diagnosed with advanced urothelial cancer that has been confirmed by a doctor. Your cancer must have shown signs of getting worse during or after you've had immunotherapy. You also need to be well enough to receive standard chemotherapy treatments.

There are also some important points about your general health and previous treatments. You must have at least one measurable area of cancer that doctors can track. Your overall health and ability to perform daily activities, as assessed by a doctor, should be good. You cannot have received platinum-based chemotherapy within the last year, and you should not have had more than two previous cancer treatments in total for advanced disease. If you received treatment before surgery or for early-stage cancer, your cancer must have come back within 12 months for you to be eligible.

Certain conditions would prevent you from taking part, such as having active, untreated cancer that has spread to your brain. Also, if you have previously had specific types of chemotherapy (topoisomerase 1 inhibitor) or other particular new cancer drugs (ADC therapy targeting EGFR or HER3), you would not be able to participate. The study team will review all your medical information carefully to ensure it's safe for you to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have advanced urothelial cancer?
Has your cancer progressed after immunotherapy?
Are you generally well enough to receive chemotherapy?
Have you not had specific types of cancer treatment in the last 12 months or ever?
Do you not have untreated cancer spread to your brain?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to either receive the new medicine, Iza-bren, or one of the standard chemotherapy treatments. This decision is made by chance, like flipping a coin. You will have regular visits to the hospital or clinic for your treatment, blood tests, and scans to check how you are responding and to monitor for any side effects. The exact number of visits will depend on which treatment you receive and how long you are on the study. Your health will be monitored closely throughout the treatment period and for a certain time after your treatment ends. The total duration of your participation in the study will vary, depending on how your cancer responds to the treatment.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available and extensive medical monitoring. However, there are also potential risks, including side effects from the study medication or standard chemotherapy, which can range from mild to severe. There is no guarantee that the new treatment will be effective for you, or that it will be better than existing treatments. You can choose to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (162)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Local Institution - 0167
Verified postcode
Gilbert, United States· Not yet recruiting
Local Institution - 0162
Verified postcode
Fullerton, United States· Not yet recruiting
Palo Alto Center-Palo Alto Medical Foundation Research Institute
Verified postcode
Palo Alto, United States· Recruiting
Sutter Health - Sutter Institute for Medical Research
Verified postcode
Sacramento, United States· Recruiting
University of California Davis (UC Davis) Comprehensive Cancer Center
Verified postcode
Sacramento, United States· Recruiting
Pacific Hematology Oncology Associates
Verified postcode
San Francisco, United States· Recruiting
Sutter Santa Rosa
Verified postcode
Santa Rosa, United States· Recruiting
Rocky Mountain Cancer Centers, LLP
Verified postcode
Denver, United States· Recruiting
Local Institution - 0245
Verified postcode
Dillon, United States· Withdrawn
Shaw Cancer Center
Verified postcode
Edwards, United States· Recruiting
Sibley Memorial Hospital
Verified postcode
Washington D.C., United States· Recruiting
Local Institution - 0247
Verified postcode
Miami, United States· Not yet recruiting

Common questions

What is urothelial cancer?

Urothelial cancer is a type of cancer that starts in the lining of the urinary system, most commonly the bladder, but can also be found in the kidneys or ureters. In this study, 'advanced' means the cancer has spread beyond its original location.

What does 'immunotherapy' mean in this context?

Immunotherapy is a type of cancer treatment that helps your body's own immune system fight cancer. The study is for people whose cancer has progressed after they have had this type of treatment.

What is 'Iza-bren'?

Iza-bren (Izalontamab Brengitecan) is the new medicine being tested in this study. It is an experimental drug, not yet approved for widespread use, and researchers are trying to understand its effects on urothelial cancer.

Why a 'Phase 2/3' study?

This means the study is in advanced stages of testing. Phase 2 looks at whether the drug works and is safe, while Phase 3 compares it to existing treatments in a larger group of people. Combining them speeds up the research process.

Can I choose which treatment I receive?

No, if you join this study, whether you receive Iza-bren or standard chemotherapy is decided by chance, like a lottery. This is to ensure the study results are fair and unbiased.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

clinical.trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.