A single arm phase II study, LUN15-299, for patients who have been previously treated for mesothelioma is being conducted by the Hoosier Cancer Research Network and led by HealthPartners Regions Cancer Care in St. Paul, Minn.

The clinical trial will test how the addition of an antiangiogenic therapy drug, ramucirumab, will work with nivolumab, an immunotherapy drug. Researchers hope the combined therapy will help keep the cancer under control.

Mesothelioma, which is caused by asbestos exposure, is a form of cancer that originates in the pleura, the membrane covering the lungs. The disease currently has no standard treatment beyond the use of pemetrexed in combination with a platinum-based chemotherapy. Most people with mesothelioma present with unresectable disease, one which cannot be removed completely through surgery.

Nivolumab enables the immune system to recognize and kill cancer cells. The addition of ramucirumab is designed to block the formation of new blood vessels, which cancer cells need to grow. Ramucirumab has not been tested in combination with nivolumab.

“There is a lot of interest right now in introducing immunotherapy to mesothelioma and there are several trials that are currently ongoing in the United States and other parts of the world. However, what is unique about this study that has not been done yet is to combine immunotherapy with antiangiogenic therapy,” said Arkadiusz Z. Dudek, MD, PhD, sponsor-investigator of the research study, an oncologist at HealthPartners Regions Cancer Care and Frauenshuh Cancer Care Centers. “We hope the addition of antiangiogenic therapy to immunotherapy will benefit more patients with mesothelioma, as compared to using immunotherapy alone.”

The study, titled “Phase II Study of Nivolumab and Ramucirumab for Patients with Previously-Treated Mesothelioma,” is open to patients ages 18 and above with mesothelioma, who received prior treatment with pemetrexed. Subjects participating in the study will receive ramucirumab plus nivolumab every two weeks for up to two years, as long as the disease does not worsen or cause severe side effects. Participants may withdraw from the study at any time if they no longer wish to receive the treatment. Up to 35 patients may enroll in the study, which will be offered at several sites across the country.

This study is supported by Eli Lilly and Company and Bristol-Myers Squibb.

Ramucirumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced lung, colorectal, and gastric or gastric-esophageal junction cancer. Nivolumab is approved by the FDA to treat certain cancers. The use of ramucirumab in combination with nivolumab to treat mesothelioma is considered investigational and has not been approved by the FDA.

Participants will provide a biopsy at the beginning of the study to support correlative research to help determine why some people do not respond to treatment and to identify potential targets for this therapy versus others, based on certain tumor characteristics.

“We are trying to use very sophisticated tumor imaging techniques that will annotate every single spot in a tumor with an immune cell or tumor cell’s location,” Dr. Dudek said. “And through that we will be able to understand the tumor-immunologic processes before the study starts with the tissue available from initial biopsy, and then while on the study.”

For more information about this research study, including full eligibility requirements, visit www.clinicaltrials.gov (study #NCT03502746).

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.