Bladder cancer is the fifth most common cancer in the United States. It begins in the cells in the lining of the bladder. It often spreads into the muscle layer of the bladder, to other parts of the body, and to lymph nodes in the pelvis.
The INSPIRE research study (EA8185) is for adults with bladder cancer that has spread to the lymph nodes. It is looking at a way to eradicate cancer while at the same time preserving the bladder and giving patients the best possible outcome and quality of life after treatment.
The study has two groups. All trial participants will receive the usual treatment for this cancer, which is chemotherapy and radiation. One group will also receive a drug called durvalumab (dur-VAL-yoo-mab), a type of immune system therapy. The purpose of this trial is to find out which treatment approach leads to better results and helps patients delay or avoid surgery.
Immunotherapy with durvalumab may help the body’s immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Durvalumab is already approved by the Food and Drug Administration (FDA) to treat other cancers, but it is still being studied in bladder cancer.
“The INSPIRE study gives patients with bladder cancer that has spread to the lymph nodes access to an innovative treatment approach only available through a clinical study,” said lead researcher Monika Joshi, MD, of the Penn State Cancer Institute.
The study will evaluate about 102 participants. Patients must be at least 18 years old and must not have had previous radiation therapy to the pelvic area. They may or may not have completed chemotherapy (per their doctor's choice) before being assigned to one of the two groups. However, if they did, the bladder cancer must not have gotten worse after treatment.
After patients complete the study treatment, they will have follow-up tests. Based on the results, the patient’s doctor will decide if they need more treatment or simply return for regular monitoring. The tests may include CT scans of the bladder every 3 months in the first year, every 6 months in the second year, then once a year in the third and fourth years.
Learn more about EA8185/INSPIRE at ecog-acrin.org.