Recruiting

Testing an immunotherapy drug for advanced cancer in patients with autoimmune disease

Plain-English translation of NCT03816345 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This study is testing whether , a medication that helps the immune system fight cancer, can be safely used in people who have both advanced cancer and an autoimmune disease (such as rheumatoid arthritis, lupus, inflammatory bowel disease, or multiple sclerosis). Normally, these immunotherapy drugs carry a risk of making autoimmune diseases worse, so researchers want to understand how safe and effective this medication is in this specific group of patients.

People with autoimmune diseases have been largely excluded from cancer immunotherapy trials because doctors worry the treatment could trigger or worsen their underlying autoimmune condition. This trial exists to fill that gap by carefully studying whether this medication can be used safely and effectively in patients who have both conditions.

Do you qualify?

You likely qualify if…

you have been diagnosed with advanced or unresectable cancer (such as melanoma, lung cancer, bladder cancer, or certain other solid tumors) for which this medication is approved
you have been diagnosed with an autoimmune disorder such as rheumatoid arthritis, lupus, inflammatory bowel disease, multiple sclerosis, psoriasis, or similar conditions
you are at least 18 years old
you have adequate organ function based on blood tests (normal blood counts, liver and kidney function)
you are healthy enough to tolerate cancer treatment, with a life expectancy of at least 12 weeks

You likely don't qualify if…

you have received other immunotherapy drugs within the required washout period (at least 4 to 6 weeks depending on the type)
you have uncontrolled or severe autoimmune disease that your doctor believes could be dangerously worsened by this medication
you have untreated or uncontrolled infection, including untreated hepatitis B or active hepatitis C
you are pregnant or breastfeeding
you have severe organ dysfunction that prevents safe participation

What participation looks like

You would receive the medication as an intravenous infusion (through a vein) every 4 weeks, with each infusion lasting about 30 minutes. Depending on your cancer type, you may receive this treatment alone or in combination with other approved cancer medications for up to 1 to 2 years. Throughout the trial, you would have regular blood tests, imaging scans, and clinic visits to monitor how the medication is working and watch for any side effects. The study team will also collect blood, tissue, and other samples to help understand why some patients respond better than others.

Testing an immunotherapy drug for advanced cancer in patients with autoimmune disease

What is this trial?

Do you qualify?

What participation looks like

Trial locations(52 sites)