Capivasertib + Immunotherapy for Bladder Cancer

This trial investigates whether adding Capivasertib to standard immunotherapy can improve outcomes for people with advanced bladder cancer. Capivasertib, an oral medication approved for breast cancer, is being tested for its potential benefits alongside bladder cancer immunotherapy. Researchers aim to determine if this combination can aid patients whose cancer no longer responds to standard treatments. Suitable candidates for this trial include individuals with advanced bladder cancer that has stopped responding to immunotherapy and who still experience mild or no symptoms. As a Phase 1/Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Previous studies have shown that Capivasertib can cause common side effects, such as diarrhea and rash, in patients treated for breast cancer. The FDA has approved Capivasertib for breast cancer, indicating it is considered safe for that use.

Capivasertib is unique because it targets a specific enzyme called AKT, which plays a crucial role in cancer cell growth and survival. Unlike standard treatments for bladder cancer, such as chemotherapy and immune checkpoint inhibitors that focus on different mechanisms, Capivasertib works by directly inhibiting this enzyme, potentially leading to improved outcomes. Researchers are excited about combining it with immunotherapy, as this approach might enhance the body's immune response against cancer cells and offer a more effective treatment option for patients.

Research has shown that Capivasertib works well for some types of cancer. It is already approved for breast cancer because it stops cancer cells from growing. Although not yet approved for bladder cancer, similar drugs have been found to enhance the effectiveness of immunotherapy. In this trial, participants will continue immune checkpoint inhibitor (ICI) treatment, with the addition of Capivasertib. Immunotherapy is used for advanced bladder cancer, but it doesn't help everyone. Adding Capivasertib might assist those who don't respond well to immunotherapy by potentially boosting the immune system's ability to fight the cancer.⁶⁷⁸⁹¹⁰