Capivasertib + Immunotherapy for Bladder Cancer

Not yet recruiting at 3 trial locations
CP
CY
Overseen ByChun Yang, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

CP

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

I am able to care for myself and perform daily activities.
I am eligible regardless of my gender.
I have advanced or recurrent urothelial carcinoma confirmed by my doctor.
See 21 more

Exclusion Criteria

Known or suspected hypersensitivity to study drugs or components
I do not have symptoms from brain or spinal tumors and have not needed steroids for 4 weeks.
I currently have an active tuberculosis infection.
See 22 more

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

Group I: treatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+