Last updated on June 2019

A Randomized Phase 3 Comparison of IMO-2125 with Ipilimumab versus Ipilimumab Alone in Subjects with Anti-PD-1 Refractory Melanoma

Brief description of study

The ILLUMINATE-301 study will look at the safety and effectiveness of an investigational drug called tilsotolimod (IMO-2125) in combination with an already approved treatment, an immunotherapy drug called Yervoy® , also known as ipilimumab.  This combination will be compared to Yervoy® given by itself in patients who have refractory melanoma, melanoma that has not responded to available approved treatments.

The study drug Tilsotolimod, also known as IMO-2125, is an investigational drug.  It is called this because it has not been approved by any health authorities including the FDA (US Food and Drug Administration) or EMA (European Medicines Agency).

Tilsotolimod is thought to work by helping to stimulate the body's immune system to target and attack the cancer cell in the body.  Drugs that boost the immune system to help the body fight cancer cells and other diseases are called immunotherapy drugs.  Early research on tilsotolimod suggests that it may provide better tumor control when combined with other immunotherapy drugs such as Yervoy®.  Tilsotolimod is given as an injection directly into the tumor.

Yervoy® is an already approved immunotherapy drug that is used to treat advanced melanoma.  Yervoy® is given as an IV infusion.


If you are enrolled in the study, you will be assigned by chance to one of 2 treatment groups, Group A or Group B.  You have an equal chance of being assigned to each group.

  • Group A - will receive Yervoy® up to 4 times over a 10 week period.
  • Group B - will receive the study drug ( tilsotolimod /IMO2125) up to 9 times.  You will also receive Yervoy® during 4 of those treatments (in combination) over a 24 week period.


Travel support may be available to help you to your study visits.


Clinical Study Identifier: TX218020

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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