Recruiting

Testing an injection to boost immune response in advanced melanoma

Plain-English translation of NCT04126876 on ClinicalTrials.gov ↗ · Source last updated April 2021 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing a new treatment called (IMO-2125), which is an injection designed to stimulate your immune system at the site where your melanoma was removed. The goal is to help your body better recognize and fight any remaining cancer cells and reduce the chance that melanoma will return after surgery. This treatment is being tested in patients with thicker, more advanced melanomas.

Currently, there is no standard treatment to help prevent melanoma from coming back after surgery in patients with advanced disease. This medication aims to activate your local immune system right at the tumor site, which early research suggests could improve survival and reduce recurrence rates.

Do you qualify?

You likely qualify if…

you are 18 years or older
you have been diagnosed with melanoma that is deeper than 2.0 mm and has not spread to lymph nodes or other parts of your body
you are scheduled to have surgery to remove your melanoma and check your lymph nodes
you are in generally good health (WHO Performance Status 0 or 1)
you are willing to use effective birth control for at least 90 days after receiving the injection

You likely don't qualify if…

you have an allergy to similar types of injected medications called oligodeoxynucleotides
you have an active autoimmune disease that requires ongoing treatment
your melanoma has already spread to nearby lymph nodes or distant parts of your body
you have another active cancer or recent cancer diagnosis
you are pregnant, breastfeeding, or have an active infection requiring antibiotics

What participation looks like

If you join this trial, you will receive either the immune-boosting injection or a placebo (saline) as a single injection at the site of your melanoma removal, about one week before your scheduled lymph node biopsy surgery. After that, researchers will follow your progress to see if the treatment affects your lymph node status and whether melanoma returns. You will be monitored over time to compare outcomes between the two groups.

AI-generated summary from trial data · Jun 15, 2026 · Not medical advice

Testing an injection to boost immune response in advanced melanoma

What is this trial?

Do you qualify?

What participation looks like

Trial locations