Mayo Clinic opens new clinical trial for mesothelioma

Research and clinical trials

Researchers at the renowned Mayo Clinic in Rochester, Minnesota, have opened the first clinical trial for mesothelioma patients combining newly approved immunotherapy with targeted radiation.

There is a possibility to extend survival.

This phase I, single-center clinical trial begins June 24, and is expected to enroll at least 20 participants. She will study the safety and efficacy of stereotaxic body guided radiotherapy, known as SBRT, when added to the combination of Opdivo and Yervoy immunotherapy.

“The reason behind this study is that we need to build on the success we’ve seen in immunotherapy in treating mesothelioma and move forward with that momentum,” Mayo Clinic radiation oncologist Dr. William Breen told the Mesothelioma Center. At Asbestos.com. “Hope to see some real synergy.”

In October 2020, the US Food and Drug Administration approved the combination of Opdivo and Yervoy to treat mesothelioma. It was the first first-line systemic therapy approved for the treatment of mesothelioma 16 years ago. It was also considered a significant advance, with survival extended by 30% over previous standard of care.

Combined immunotherapy works best for mesothelioma

Opdivo and Yervoy, also known by the generic names nivolumab and ipilimumab, respectively, are produced by pharmaceutical company Bristol Myers Squibb. Its effectiveness includes harnessing the patient’s immune system to better attack the cancer.

Other immunotherapies could also be used, Brin said, depending on the allocation of enrolled patients.

At a time when immunotherapy is touted as a major advance in the treatment of many types of cancer, most mesothelioma specialists agreed that its ultimate efficacy would include synergy with other treatments, leading to the latest studies.

Opdivo and Yervoy, for example, have shown success in an estimated half of patients with pleural mesothelioma, and these have been of varying degrees.

“We know that immunotherapy improves survival,” Brin said. “But let’s see how much better it can be when combined with another effective treatment.”

Memorial Sloan Kettering launched a similar experience

Memorial Sloan Kettering Cancer Center in New York opened a similar trial in 2018 for mesothelioma involving SBRT, but with the immunotherapy drug avelumab, which alone has not been shown to be as effective as Opdivo and Yervoy. That trial stopped recruiting patients. The principal investigator declined to provide a study update to Asbestos.com.

In July, Memorial Sloan-Kettering is set to open another mesothelioma clinical trial studying the immunotherapy drug Keytruda in combination with modified pleural radiotherapy, known as IMPRINT.

Keytruda has been approved by the Food and Drug Administration (FDA) for a small portion of mesothelioma patients in the second-line setting when no alternative options are available.

Mayo offers expertise in mesothelioma research

Modern Mayo Clinic has been a National Cancer Institute comprehensive cancer center for more than 40 years. It is consistently ranked among the best centers in the country for cancer care. The Mesothelioma Program has been praised for excellence in research.

“Our study here was built from a multidisciplinary collaboration that included oncologists, pulmonologists, and radiation oncologists,” Brin said. “We now know that immunotherapy improves survival. We have seen synergies with immunotherapy and this type of radiation work really well with other cancers.”

Patients in the Mayo clinical trial will have three to five daily portions of SBRT, along with immunotherapy, at the discretion of the oncologist.

It is expected that higher doses of tightly directed radiation will help the immune system better recognize tumor cells as foreign cells, making them more susceptible to immunotherapy drugs.

“Our primary goal is to demonstrate that this is a safe and beneficial option, but we also hope to see good success in treating cancer effectively for these patients,” Brin said. “By combining these two treatments, we hope to build on the momentum that already exists today.”