Izalontamab Brengitecan for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, Izalontamab Brengitecan, for individuals with bladder cancer that has spread and worsened after previous treatment, specifically immunotherapy. The study compares this treatment to the usual platinum-based chemotherapy to determine which is more effective for this cancer type. Suitable candidates for this trial include those whose bladder cancer has returned or progressed within 12 months after previous treatments and have at least one measurable tumor. As a Phase 2/3 trial, it evaluates the treatment's effectiveness in a larger group and is one step away from potential FDA approval, offering participants a chance to advance cancer treatment.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Izalontamab Brengitecan appears safe in studies. It achieved a 44.1% success rate in shrinking tumors and an 88.2% rate in controlling the disease in patients with advanced bladder cancer, indicating many patients responded well to the treatment.
In other studies, patients lived without disease progression for an average of 7.3 months, suggesting the treatment may slow the disease without causing serious side effects. These results indicate the treatment is generally well-tolerated, with no major safety issues reported so far.
Although the treatment remains under study, the evidence so far is encouraging for its safety in humans.12345Why are researchers excited about this trial's treatments?
Izalontamab Brengitecan is unique because it represents a novel approach in the treatment of bladder cancer, potentially offering new hope for patients. Unlike traditional treatments such as chemotherapy and immunotherapy, Izalontamab Brengitecan combines an antibody-drug conjugate that specifically targets cancer cells, delivering a powerful anti-cancer agent directly to the tumor. This targeted mechanism of action minimizes damage to healthy cells, potentially reducing side effects compared to standard treatments. Researchers are excited about its ability to precisely attack bladder cancer cells, which could lead to more effective outcomes and improved quality of life for patients.
What evidence suggests that this trial's treatments could be effective for metastatic urothelial cancer?
Research has shown that Izalontamab Brengitecan, which participants in this trial may receive, offers promising results for treating bladder cancer. In patients with advanced bladder cancer, nearly half experienced tumor shrinkage. The treatment also stabilized the disease for most patients, with 88.2% achieving disease control. Additionally, studies found that patients went an average of 7.3 months without disease progression, and 66.4% had no progression at 6 months. These findings suggest that Izalontamab Brengitecan could be a promising option for those whose cancer has worsened after standard immunotherapy.12345
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for adults with advanced bladder cancer that has worsened after immunotherapy. They should be fairly active and healthy (ECOG 0-1), have not had platinum chemo in the last year, no more than two prior cancer treatments, and no untreated brain metastases or certain previous drug treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Izalontamab Brengitecan or platinum-based chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Izalontamab Brengitecan
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania