A Hoosier Cancer Research Network study for patients with high-risk ocular melanoma, a rare type of cancer affecting the eye, is now open for accrual. According to the National Cancer Institute, ocular melanoma often doesn’t present early signs or symptoms.

Typically, patients with ocular melanoma can choose to have surgery to remove the eye, called enucleation, or receive radiation to the eye. After either treatment, patients are monitored for recurrence of their disease. Patients with high-risk ocular melanoma have a risk of cancer recurrence of up to 50% within 3 years after receiving initial treatment for their disease.

A number of treatment options are now available for patients with cutaneous melanoma, which begins in skin cells called melanocytes, the pigment-producing cells that generate pigments of our skin, hair, and eyes. However, progress in treating high-risk ocular melanoma has eluded researchers.

“This is an area of urgent need for treatment,” said Suthee Rapisuwon, MD (pictured), an oncologist at Georgetown Lombardi Comprehensive Cancer Center in Washington, DC, and sponsor-investigator of the study. “Unlike advanced cutaneous melanoma, where immune checkpoint blockade and targeted therapy have demonstrated good survival and clinical benefit in a substantial subset of patients, systemic therapies in advanced ocular melanoma have produced unsatisfactory results, with median survival of about one year. After the definitive treatment to the primary tumor for ocular melanoma, there is no approved adjuvant treatment for this patient group. Developing effective therapy in the adjuvant setting to decrease the risk of recurrence is our priority.”

The study, MEL17-309, titled “Phase II single-arm multi-center study of adjuvant ipilimumab in combination with nivolumab in subjects with high-risk ocular melanoma,” will compare the relapse-free survival (RFS) rate — the percent of study participants who show no signs of cancer recurrence — at three years after being treated with immune checkpoint inhibitors, nivolumab and ipilimumab, versus a control population from the Cure OM Patient Registry, available through the Melanoma Research Foundation.

The research will also assess overall survival and the safety and tolerability of the combined treatment, and will include the collection of tissue, blood, and stool samples at the time of diagnosis and at the time of disease progression. These samples will allow researchers to conduct biomarker studies, often referred to as correlative research, that may help identify predictors of response and toxicities to treatment.

Up to 50 patients will participate in the study. To be eligible, patients must be adults ages 18 and older and have ocular melanoma that is considered high-risk for recurrence. Sites currently enrolling participants include Columbia University Irving Medical Center in New York, N.Y.; Georgetown Lombardi Comprehensive Cancer Center in Washington, D.C.; MD Anderson Cancer Center in Houston, Texas; Robert H. Lurie Comprehensive Cancer Center of Northwestern University in Chicago, Ill.; Washington University School of Medicine in St. Louis, Mo.; and University of California San Francisco.

Participants in this study will be treated with nivolumab 240 mg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks for up to one year, or until disease progression, unacceptable toxicity, or the participant chooses to discontinue study treatment.

Support for this study is provided by Bristol-Myers Squibb.

For more information about this research study, including full eligibility requirements, visit www.clinicaltrials.gov (study #NCT03528408).

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 conducted more than 210 trials in a variety of cancer types and supportive care, resulting in more than 350 publications. More than 8,500 subjects have participated in Hoosier Cancer Research Network clinical trials.