Ongoing Trials: The EA8231 research study is testing a new treatment for advanced bladder cancer that continues to grow despite standard treatment

Bladder cancer (urothelial carcinoma) is the fifth most common cancer in the United States. About 80% of cases are diagnosed at an early stage, and new treatments have improved results for many patients. Treatments may include various combinations of chemotherapy, immunotherapy, and/or targeted therapy. However, advanced bladder cancer that does not respond to treatment remains challenging, with limited effective options available.

The 5-year survival rate is about 40% for patients whose cancer has spread just beyond the bladder, and only about 9% for patients whose cancer has spread to distant parts of the body.

The usual approach for patients with bladder cancer that continues to grow despite standard treatment is additional chemotherapy. Researchers are also studying a newer treatment called sacituzumab govitecan, a type of targeted cancer therapy.

Early research suggests that combining sacituzumab govitecan with the immunotherapy drug pembrolizumab may be more effective than chemotherapy for some patients. In particular, it may be better for those whose tumors have high levels of a protein called PD-L1, which helps cancer cells hide from the immune system. Clinical trials in other types of cancer suggest that this treatment combination helped patients live longer without their cancer worsening.

The EA8231 research study is for patients with advanced bladder cancer that has not previously responded to immunotherapy drugs that target PD-L1. Researchers are comparing the new treatment approach—pembrolizumab plus sacituzumab govitecan—to standard chemotherapy.

To participate in EA8231, patients must have already completed at least one standard treatment regimen for advanced or metastatic bladder cancer. Standard treatment must have included immunotherapy that targets PD-L1. They must also have already received enfortumab vedotin, another targeted treatment. Patients cannot participate if they have already been treated with sacituzumab govitecan or certain similar drugs.

Participants will be randomly assigned by a computer to one of two treatment groups. One group will receive the usual chemotherapy, and the other group will receive sacituzumab govitecan and pembrolizumab. Treatment will continue until the cancer grows or side effects become too severe. All patients will be followed by their doctor for up to 5 years.

Even with new treatments, survival rates for advanced bladder cancer remain low. This phase 3 trial will help determine whether combining sacituzumab govitecan with pembrolizumab can provide greater benefit than standard chemotherapy. The findings could lead to a new treatment option for these patients.

Learn more about EA8231 at ecog-acrin.org.

For more information about bladder cancer or to find resources and support, visit the Bladder Cancer Advocacy Network website.