Hoosier Cancer Research Network (HCRN) recently launched a cancer clinical trial evaluating the efficacy of the PDL-1 inhibiting drug pembrolizumab in the treatment of patients with incurable platinum refractory germ cell tumors.

The study, known as HCRN GU14-206, is now open to accrual at the Indiana University Melvin and Bren Simon Cancer Center. This is a single arm study in which all subjects will receive the study drug, pembrolizumab.

Men and women age 18 and older who have incurable platinum refractory germ cell tumors (testicular or ovarian) may be eligible for this study. Other criteria must be met to fulfill eligibility requirements.

Germ cell tumors are the most common type of solid tumor cancer in men ages 15-35. The National Cancer Institute estimated 8,430 new cases would be diagnosed in the United States in 2015. Ovarian germ cell tumors are rare and occur most often in teenagers and women in their 20s.

While investigators have made great strides in the treatment of germ cell tumors, particularly through the development of cisplatin-based therapy, about 15 percent of germ cell tumor patients are considered incurable with standard chemotherapy.

“Life expectancy tends to be very short for these patients,” said Nasser Hanna, MD, the study’s sponsor-investigator and a researcher at the Indiana University Melvin and Bren Simon Cancer Center. “They tend to be young men, often in their 20s or early 30s. The available therapy in this circumstance is quite subpar. We’ll be the first to test the role of immunotherapy in men with testicular cancer.”

Typically, the body’s immune system recognizes abnormal cells and destroys them. Cancer cells often create proteins on the cell surface called PD-L1 that act as signals to turn off this part of the immune system. Pembrolizumab is a drug that blocks this signal on the immune system’s cells, and allows the immune system to recognize these cancer cells as foreign.

The use of pembrolizumab in this study is investigational. This means that the drug has not yet been approved by the FDA to treat this type of cancer.

For more information about this study, including full eligibility requirements, visit clinicaltrials.gov (study #NCT02499952).

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 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.