New Study Looks at Using Immunotherapy to Treat Advanced Cancers and Autoimmune Conditions

Immunotherapy is one of the tools used in treating cancer, but it is not known whether this treatment is safe and/or effective for those individuals who have both cancer and an autoimmune disease.¹ Many of these individuals are not able to participate in clinical trials of immunotherapy drugs because of the exclusion criteria. A new clinical trial has been started specifically to test an immunotherapy drug in those individuals who have cancer and an autoimmune disease like lupus, rheumatoid arthritis, or multiple sclerosis.¹

What is immunotherapy?

A healthy immune system finds and kills any abnormal cells, preventing illness and disease, including cancer. Immunotherapy for cancer is a kind of biological treatment that helps to boost the immune system against cancer cells and make it more efficient in fighting these abnormal cells.²

If someone with an autoimmune disease already has an overactive immune system that attacks even good, healthy cells, what will happen if the immune system is strengthened even more? That’s one of the things that scientists are trying to explore with this new study.

What questions does this study explore?

In autoimmune diseases, as mentioned above, the immune system is often overactive and attacks healthy cells, thus causing the symptoms of the autoimmune disease. In some individuals who do not have an autoimmune condition and who receive immunotherapy, one side effect is that the immune system then attacks healthy cells, causing inflammation of the lining of the colon, lungs, or heart.¹ If this happens in individuals without autoimmune conditions, what will happen with those who have such conditions?

It’s not known whether immunotherapy drugs are safe for these individuals because of what will happen if the immune system is bolstered further – will the side effects of immunotherapy be worse if they have both cancer and an autoimmune disease, or will the autoimmune disease get worse?¹ Individuals with autoimmune diseases haven’t had a chance to be given these medications, so there are a lot of unknowns – both potentially good and bad.

This is important to study because between 10 percent and 30 percent of individuals with cancer also have an autoimmune disease.¹ This study could open up a new treatment option for these individuals, and it might even have significant positive effects on their cancer or autoimmune condition or even both.

Who is participating in the study?

The clinical trial will consist of 260 people who have both cancer and an autoimmune disease, including those with Sjogren’s syndrome, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, systemic sclerosis, and more.¹ The drug they will get is nivolumab (brand name Opdivo), an immune checkpoint inhibitor that is approved by the FDA to treat a variety of cancers, including liver, lung, kidney and bladder cancer, as well as Hodgkin lymphoma.¹ During the trial, participants will be monitored for any changes in autoimmune symptoms, responses to treatment, progression-free survival, and overall survival.¹ Researchers will record clinical data, but also take tissue from organs affected by both cancer and autoimmune disease, in hopes that this will further knowledge about the biology of autoimmune diseases and side effects of immunotherapy.¹

Why immunotherapy?

Immunotherapy has been shown to be effective in a wide variety of cancers, at different stages of disease. It has been used alone or with other drugs, as well. In some people with metastatic cancer, it has even cured it.¹ The benefits of immunotherapy have been shown repeatedly, and by exploring whether those with cancer and autoimmune disease can take these medications, it opens up more treatment options to more people.

Keeping all of this in mind, those individuals with both cancer and an autoimmune disease will need an interdisciplinary team that has experience in both cancer and autoimmune diseases, to monitor any symptoms or flares, to keep track of progress and treatment response, and to mitigate any adverse effects from treatments.