Capivasertib + Immunotherapy for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This study aims to determine whether adding an oral medication called Capivasertib to ongoing immunotherapy can enhance treatment responses in patients with advanced bladder cancer (aBC), as well as to evaluate the safety of this combination. Capivasertib is an anti-cancer drug approved by the U.S. Food and Drug Administration (FDA) for breast cancer, but it is not approved for aBC and, in this study, will be used as an investigational agent. Immunotherapy is FDA-approved for aBC, yet while some patients respond, others either do not benefit or develop resistance after an initial response. Previous research indicates that drugs similar to Capivasertib may increase the effectiveness of immunotherapy. Therefore, this study will enroll patients whose aBC no longer responds to immunotherapy, add Capivasertib to their treatment regimen, and monitor for improvements in immune response against aBC and any potential side effects associated with the combination therapy.
Who Is on the Research Team?
Chong-Xian Pan, MD PhD
Principal Investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Are You a Good Fit for This Trial?
This trial is for people with advanced bladder cancer whose disease has stopped responding to immunotherapy. Participants should be adults and able to take oral medication. Those with other serious health issues or who can't safely receive the study drugs may not qualify.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Capivasertib
Trial Overview
The study tests if adding Capivasertib (an oral anti-cancer drug) to ongoing immunotherapy helps patients with metastatic bladder cancer when immunotherapy alone no longer works. The safety and effectiveness of this combination will be monitored.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients will continue ICI treatment and capivasertib will be added
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
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