Hoosier Cancer Research Network (HCRN) announces the opening of a study for patients with advanced renal cell carcinoma who have not received prior treatment for their kidney cancer.

The phase II clinical trial, known as HCRN GU16-260, involves front-line therapy with nivolumab and salvage therapy with nivolumab and ipilimumab. The study may help researchers determine the activity of nivolumab, an agent already approved for patients with previously treated kidney cancer, in patients who have not received prior treatment.

Renal cell carcinoma is the 10th most common cancer in the United States, with about 62,700 new cases diagnosed and about 14,240 deaths in 2016.

The study is now open to accrual at Georgetown Lombardi Comprehensive Cancer Center in Washington, DC, with additional HCRN sites expected to open in the near future. Michael B. Atkins, MD, of Georgetown Lombardi, is the study’s sponsor-investigator.

Nivolumab has been tested and found to have activity in a variety of cancers, including melanoma, non-small cell lung cancer, bladder cancer, head and neck cancer and previously treated kidney cancer.

“Surprisingly, because this agent has been used to treat a lot of cancers, it has never been fully studied in treatment-naïve kidney cancer patients,” Atkins said. “We thought patients might prefer initial treatment because it might mean they don’t need other treatments. We could potentially identify factors that determine who would most likely benefit from this treatment as first-line therapy.”

For those patients who do not benefit from nivolumab, the study will introduce another immunotherapy agent, ipilimumab, to see if the combination of nivolumab and ipilimumab might overcome resistance to or enhance the activity of nivolumab treatment.

The study will investigate the activity of the study drugs in not only clear cell renal cell carcinoma (ccRCC), which constitutes about 75 percent of patients with metastatic kidney cancer, but also in patients with non-clear cell (nccRCC) disease, a smaller patient population in which Dr. Atkins says little is known about the activity of immune therapy.

About the Study Drugs

The immune system sends out special cells called T cells to fight infections and diseases throughout the body. Some cancer cells can hide from T cells by taking control of a pathway called PD-1. This lets the cancer cells avoid an attack from T cells. Nivolumab, also known as Opdivo®, is an immunotherapy that blocks the PD-1 pathway. By blocking PD-1, it allows the human immune system to recognize and kill cancer cells. Ipilimumab, also known as Yervoy®, is an immunotherapy that blocks the CTLA4 immune checkpoint.

All participants in the study will start treatment with nivolumab alone, every two weeks for 12 weeks. At that time a CT scan will be performed to determine next steps on the study. Patients whose disease is stable or has responded to treatment will continue to receive nivolumab every three weeks for up to 84 weeks or until their disease worsens. Patients whose disease worsens, or remains stable for 12 months, will receive nivolumab with the addition of ipilimumab every three weeks for up to four doses. After those four doses, patients will continue nivolumab monotherapy for up to an additional 48 weeks.

Nivolumab is approved by the U.S. Food and Drug Administration (FDA) to treat patients with advanced renal cell carcinoma. Ipilimumab is FDA-approved to treat patients with melanoma. The combination of nivolumab and ipilimumab is FDA-approved for the treatment of patients with advanced melanoma. This combination is investigational in patients with advanced renal cell carcinoma.

To be eligible for this study, patients must have advanced renal cell carcinoma and have not received prior treatment for their kidney cancer. Other criteria must be met to enroll.

For more information about this study, visit www.hoosiercancer.org/clinical-trials/trial/gu16-260/, or visit www.clinicaltrials.gov and search for study identifier #NCT03117309.

Funding support for this trial is provided by Bristol-Myers Squibb Company.

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 160 trials in a variety of cancer types and supportive care, resulting in more than 350 publications. More than 5,000 subjects have participated in Hoosier Cancer Research Network clinical trials.