A new Hoosier Cancer Research Network study may help researchers learn whether the order in which two drugs are given has any effect on progression-free survival — the length of time it takes for cancer to grow or spread.

The randomized phase II study, known as HCRN GU15-223, will compare overall progression-free survival for two groups of subjects with metastatic renal cell carcinoma (kidney cancer). One group will receive first-line sunitinib, an anti-angiogenic drug, followed by second-line avelumab, an investigational immunotherapy drug. The other group will receive first-line avelumab followed by second-line sunitinib. Patients will have an equal chance of being randomized to either group.

The study is now open at the University of Alabama at Birmingham Comprehensive Cancer Center, and is expected to open soon at other Hoosier Cancer Research Network member sites. About 150 subjects will be enrolled in the study.

Avelumab is an investigational, fully human monoclonal antibody that targets PD-L1 (programmed death-ligand 1), a protein that is often highly expressed in cancer cells. PD-L1 binds to PD-1 (programmed death-1) receptors on T cells. This prevents the T cells, which are part of the body’s immune system, from carrying out their normal function of attacking cells that are foreign. Avelumab binds PD-L1 and blocks this interaction, allowing the T cells to recognize and attack the cancer cells. The U.S. Food and Drug Administration (FDA) has not approved avelumab to treat metastatic kidney cancer.

Sunitinib is approved by the FDA for the treatment of kidney cancer. It works by targeting certain receptors in tumor cells that play a role in vascularization, or the growth of blood vessels that promote tumor proliferation.

According the study’s sponsor-investigator, Guru Sonpavde, MD, of the University of Alabama at Birmingham, this study will help researchers explore unanswered questions in the use of immunotherapy in advanced kidney cancer. It will help determine whether the sequence of drugs has any effect on progression-free survival. In addition, the study may reveal whether certain patients might qualify for sequential single-agent therapies where combination therapies are not an option.

“When you look at the trials going on right now, a lot of trials are looking at combinations of PD-1 inhibitors with other agents as first-line treatment, and not the PD-1 inhibitor by itself compared with anti-angiogenic agents,” he said. “We believe this trial will answer the question of whether a single agent PD-1 inhibitor can be given in some patients who do not qualify for aggressive combinations.”

Eligible subjects must have untreated advanced/metastatic clear cell renal cell carcinoma (kidney cancer). Other criteria must be met to enroll in the study.

For more information about this study, including full eligibility requirements, visit clinicaltrials.gov (study #NCT03035630).

Funding support for this trial is provided by Pfizer, Inc.

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.