drugset / Trial / NCT07793578

Immunotherapy Plus Capivasertib for Metastatic Bladder Cancer

NCT07793578 ↗

Phase 1/2 Not yet recruiting 32 enrolled VA Office of Research and Development
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2027-01-01
Primary completion
2029-09-30
Completion
2030-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Capivasertib Small molecule 400 mg Oral

Indications