Atezolizumab +/− Eribulin Mesylate for Bladder Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, certain treatments like systemic immunosuppressive medications and some investigational agents must be stopped before starting the trial. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Atezolizumab for bladder cancer?
Atezolizumab has shown effectiveness in treating advanced bladder cancer, with studies indicating a 15% response rate and 36% one-year survival in patients who had previously received chemotherapy. It is approved for use in patients who cannot take cisplatin, with a 24% response rate and 57% one-year survival in this group.12345
Is the combination of Atezolizumab and Eribulin Mesylate safe for treating bladder cancer?
Atezolizumab (also known as Tecentriq) has been shown to have a favorable safety profile in treating advanced bladder cancer, with manageable side effects compared to traditional chemotherapy. While specific safety data for the combination with Eribulin Mesylate (Halaven) in bladder cancer is not provided, Atezolizumab alone has been well-tolerated in clinical trials.12346
How is the drug Atezolizumab +/− Eribulin Mesylate unique for bladder cancer treatment?
Atezolizumab is unique because it is a monoclonal antibody that blocks PD-L1, helping the immune system attack bladder cancer cells more effectively, and it has shown durable responses in patients who have not responded to traditional chemotherapy. It is approved for use in patients who cannot tolerate cisplatin or whose cancer has progressed after platinum-based chemotherapy, offering a new option where few existed before.12345
What is the purpose of this trial?
This phase II trial studies the side effects of atezolizumab with or without eribulin mesylate and how well they work in treating patients with urothelial cancer that has come back (recurrent), spread to nearby tissues or lymph nodes (locally advanced), or spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving atezolizumab and eribulin mesylate may work better at treating urothelial cancer compared to atezolizumab alone.
Research Team
Anishka D'Souza
Principal Investigator
City of Hope Comprehensive Cancer Center LAO
Eligibility Criteria
Adults over 18 with recurrent, locally advanced or metastatic urothelial cancer who've had platinum-based treatment within the last year. They must have recovered from previous treatments' side effects, have a life expectancy of at least 12 weeks, and measurable disease. HIV-positive patients can join if they meet certain criteria. Exclusions include autoimmune diseases, severe heart or liver conditions, recent major surgery or vaccinations, current serious infections, history of lung problems like pneumonitis, and prior bone marrow or organ transplants.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive atezolizumab with or without eribulin mesylate in 21-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Atezolizumab
- Eribulin Mesylate
Atezolizumab is already approved in United States, European Union for the following indications:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor