Ongoing Trial: The EA8192 clinical trial is testing a new treatment approach for patients with upper tract urothelial cancer

Upper tract urothelial cancer (UTUC) is a type of cancer that affects the inside lining of the kidney (urothelium) or the tube that carries urine from the kidney to the bladder (ureter). It is different from bladder cancer or kidney cancer. UTUC can be low-grade, meaning it is less likely to grow and spread to other parts of the body, or high-grade, meaning it is more likely to grow and spread. The EA8192 clinical trial is for patients in this second group, with high-grade UTUC.

The usual treatment approach for patients with high-grade UTUC is surgery to remove the kidney, entire ureter, and a small piece of the bladder. Sometimes, patients are treated with FDA-approved chemotherapy drugs before or after surgery. The usual approach may use one or more different kinds of chemotherapy depending on how patients’ kidneys function. Their doctor can explain which treatment may be best for them.

These treatments can reduce symptoms and may stop the tumor from growing for a few months or longer. However, rates of the cancer returning are high at 45%-60%. If the cancer does return, treatment options are limited because patients have compromised kidney function resulting from their surgery. Additional therapies could make their kidney function even worse.

Based on previous studies, researchers believe that if patients receive treatment with immune system therapy before surgery, they might have better results. Both chemotherapy and immune system therapy with drugs, called checkpoint inhibitors, are effective against high-grade UTUC. In the EA8192 study, researchers are looking to see if treatment with chemotherapy and immunotherapy prior to surgery is better for patients than treatment with chemotherapy alone prior to surgery.

Patients who enroll in EA8192 will be randomly assigned by a computer to receive either cisplatin-based chemotherapy and checkpoint inhibitor therapy or only cisplatin-based chemotherapy before their surgery. The checkpoint inhibitor therapy is a drug called durvalumab. Durvalumab is approved by the US Food and Drug Administration to treat several other types of cancer but is not yet approved to treat UTUC. 

Patients in both groups will have surgery, and then return for follow-up every three to six months after surgery for five years.

The study's primary goal is to compare how long patients live without their cancer coming back or getting worse. 

To be eligible for EA8192, patients must have a diagnosis of high-grade UTUC confirmed by a biopsy. Their cancer must not have any signs that it could be small cell carcinoma. The cancer must not have spread, and patients must not have any enlarged lymph nodes.

Learn more about EA8192 at ecog-acrin.org.