Immunochemotherapy for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of chemotherapy and immune therapy for patients with muscle invasive bladder cancer. It aims to help these patients keep their bladders and improve their quality of life by effectively targeting and killing cancer cells while boosting the immune system.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or other immunosuppressive medications, you may need to stop them 14 days before starting the trial. It's best to discuss your specific medications with the trial team.
Is the combination of AMVAC + Nivolumab generally safe for humans?
Nivolumab, used in combination with other treatments for bladder cancer, is generally well tolerated, but some common side effects include fatigue, low blood cell counts, muscle pain, decreased appetite, and nausea. It has been approved for use in bladder cancer after other treatments have failed, indicating a recognized safety profile.12345
How is the drug AMVAC + Nivolumab different from other bladder cancer treatments?
AMVAC + Nivolumab combines a dose-intense chemotherapy regimen (AMVAC) with an immunotherapy drug (Nivolumab) that targets the PD-1 pathway, potentially enhancing the immune system's ability to fight cancer. This combination aims to provide a more effective treatment by leveraging both chemotherapy and immunotherapy, which is different from traditional treatments that typically use only one approach.14678
What data supports the effectiveness of the drug AMVAC + Nivolumab for bladder cancer?
Nivolumab, a part of the AMVAC + Nivolumab treatment, has been approved by the FDA for advanced bladder cancer after showing effectiveness in patients whose disease progressed on platinum chemotherapy. This approval is based on its ability to target and block a protein that helps cancer cells evade the immune system, thereby promoting antitumor activity.1291011
Who Is on the Research Team?
Pooja Ghatalia, MD
Principal Investigator
Fox Chase Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with muscle invasive bladder cancer (MIBC) without prior chemotherapy or radiation for urothelial carcinoma, no autoimmune diseases, and not on significant immunosuppressive medications. Participants must have normal organ function, no evidence of metastasis or lymph node positive disease unless biopsy-proven negative, and a good performance status.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive neoadjuvant nivolumab with AMVAC for muscle invasive bladder cancer
Active Surveillance
Patients with complete clinical response undergo active surveillance to preserve their bladders
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AMVAC + Nivolumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fox Chase Cancer Center
Lead Sponsor