Each year in the United States, more than 70,000 patients are diagnosed with bladder cancer, and more than 14,000 will die from their disease. The current standard for treating bladder cancer involves chemotherapy, but this approach is not adequate for many patients, particularly those whose disease has metastasized, or spread to other parts of the body.

A new Hoosier Cancer Research Network study may help researchers determine whether a novel approach involving a combination of immunotherapy drugs might benefit patients with advanced disease who are not eligible to receive cisplatin-based chemotherapy.

[Arjun Balar, MD (pictured), of the New York University Langone Medical Center, is sponsor-investigator of the HCRN GU15-215 study.]

The single-arm phase II study, known as HCRN GU15-215, involves the anti-PD-L1 antibody atezolizumab with bevacizumab, a VEGF-targeting antibody that may help to prevent the growth of new blood vessels that feed tumors. Bevacizumab may act in combination with atezolizumab to enhance the anti-tumor immune response.

Normally, T cells in the human body recognize and attack cells that are foreign. T cells express a protein called PD-1 (for “programmed death-1”), which binds to PD-L1 (“programmed death-ligand 1”) on the surface of tumor cells. This binding prevents the T cells from recognizing the cancer cells as foreign. Atezolizumab works by blocking this interaction, which allows the T cells to recognize and attack the tumor cells.

The study is now open to accrual at New York University Langone Medical Center, West Cancer Center in Memphis, Tenn., and HealthPartners Institute in Minneapolis, Minn. Additional sites plan to open the study in the near future. Arjun V. Balar, MD, of the NYU Langone Medical Center is leading the study, along with co-investigators Jonathan E. Rosenberg, MD, and Samuel A. Funt, MD of Memorial Sloan Kettering Cancer Center.

About 70 subjects will participate in the study. All subjects will receive atezolizumab and bevacizumab every three weeks for up to 24 months, or until they experience unacceptable side effects or their disease worsens.

The combination of atezolizumab and bevacizumab has not been approved by the U.S. Food and Drug Administration to treat advanced/unresectable bladder cancer and should be considered investigational.

“There is evidence of synergy between atezolizumab and bevacizumab compared to either drug by itself according to other trials,” said Dr. Rosenberg. “We are eager to test this combination in bladder cancer.”

To enroll in HCRN GU15-215, subjects must have advanced/unresectable urothelial carcinoma of the bladder, ureter, urethra, or renal pelvis. Additional eligibility requirements must be met to enroll.

This trial is supported by Roche/Genentech.

For more information about this study, including full eligibility requirements, visit www.clinicaltrials.gov (study #NCT03272217).

About Hoosier Cancer Research Network:

Hoosier Cancer Research Network (formerly known as Hoosier Oncology Group) conducts innovative cancer research in collaboration with academic and community physicians and scientists across the United States. The organization provides comprehensive clinical trial management and support, from conception through publication. Created in 1984 as a program of the Walther Cancer Institute, Hoosier Cancer Research Network became an independent nonprofit clinical research organization in 2007. Since its founding, Hoosier Cancer Research Network has initiated more than 210 trials in a variety of cancer types and supportive care, resulting in more than 350 publications. More than 8,500 subjects have participated in Hoosier Cancer Research Network clinical trials.