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HCRN study compares pembrolizumab to placebo as “maintenance” therapy in metastatic bladder cancer

A new Hoosier Cancer Research Network study is exploring the effects of pembrolizumab in treating metastatic urothelial cancer. The study, known as GU14-182, will compare maintenance pembrolizumab to a placebo in subjects after first-line chemotherapy for metastatic urothelial cancer (e.g., cancer of the bladder, urethra, ureter, or renal pelvis).

The study is currently open to accrual at the Tisch Cancer Institute at Mount Sinai.

The standard approach to treating metastatic urothelial cancer is chemotherapy administered for about 4-6 cycles. If the disease has stabilized or responded, treatment is usually stopped and patients are monitored until their cancer starts to grow again. This is the standard approach because continuing additional standard chemotherapy usually leads to an increase in side effects without necessarily improving the results achieved with chemotherapy. GU14-182 will test whether or not this “stop and wait” approach can be improved by administering pembrolizumab following chemotherapy, according to the study’s sponsor investigator, Matthew Galsky, MD, director of genitourinary medical oncology at the Tisch Cancer Institute at Mount Sinai.

“There is interest in determining whether or not we can do something else after patients stop standard chemotherapy, rather than just waiting, that builds on the improvement that’s achieved with chemotherapy,” he said.

One approach to improve on the response to first-line chemotherapy would be to have the patient’s immune system “take over” and attack the remaining cancer. However, cancer cells have found ways to shield themselves from the immune system by upregulating certain proteins.

“The body’s immune system is very smart and adaptable, and it eradicates things that are abnormal in the body, like infections or, potentially, cancer,” Dr. Galsky said. “But when a cancer grows and spreads to other parts of the body, it’s found a way to avoid that process. One of the ways that it avoids that process is by up-regulating a molecule or protein that acts as a shield to the body’s immune system.”

Pembrolizumab is a drug that blocks the signal produced by PD-1 and allows the immune system to recognize and attack these cancer cells.

Pembrolizumab has shown encouraging results in preliminary studies in patients with more advanced urothelial cancer. However, the use of pembrolizumab in this study is investigational. This means that the FDA has not approved pembrolizumab for this type of cancer.

To be eligible, study participants must have had metastatic urothelial cancer of the bladder, urethra, ureter, or renal pelvis. Additional criteria must be met to be eligible for this study.

Study participants will be randomized to one of two groups. The first group, called Arm A, will receive a placebo. The second group, called Arm B, will receive the study drug pembrolizumab.

See clinicaltrials.gov (study #NCT02500121) for more information about this trial.

About Hoosier Cancer Research Network:

Hoosier Cancer Research Network (formerly known as Hoosier Oncology Group) conducts innovative cancer research in partnership with academic and community physicians and scientists across the United States and internationally. 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 150 trials in a variety of cancer types and supportive care, resulting in more than 300 publications. More than 4,600 subjects have participated in Hoosier Cancer Research Network clinical trials.