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Treatment Study for Patients with Melanoma

Clinical Trial Title: 
A randomized phase 3 comparison of IMO-2125 with ipilimumab versus ipilimumab alone in subjects with PD 1 refractory melanoma.
Clinical Trial Protocol ID: 
Clinical Trial Investigator Name: 
Timothy Kuzel, MD
Clinical Trial Protocol Description: 

Study for ipilimumab with or without IMO-2125 for subjects with melanoma and to collect additional data on treatment safety.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Are 18 years of age or older.
  • Have histologically confirmed metastatic melanoma with measurable (by RECIST v1.1), stage III (lymph node or in transit lesions) or stage IVA, IVB, or IVC disease that is accessible for injection.
  • Have confirmed progression during or after treatment with either nivolumab or pembrolizumab. Confirmed progression is defined as: Radiological progression (confirmed at least 4 weeks after the initial scan showing PD; or (for progression based solely on worsening of non-target or new, non-measurable disease) confirmation by an additional scan at least 4 weeks after the initial scan unless it is accompanied by correlative symptoms.
  • Have no intervening anti-cancer therapy between the last course of nivolumab or pembrolizumab and the first dose of study treatment is allowed except for local measures (e.g., surgical excision or biopsy, focal radiation therapy).
  • Have had at least 21 days between last nivolumab or pembrolizumab and start of study treatment, with no residual anti-PD-1-related immune toxicities in excess of Grade 1 severity.
  • Are undergoing BRAF inhibitor treatment (alone or in combination with a MEK inhibitor), if the tumor carries a BRAF V600E or V600K mutation.
  • Have an ECOG Performance Status ≤ 1.

You will be excluded from the study if any of the following criteria apply to you:

  • Have ocular melanoma.
  • Have had prior therapy with a TLR agonist, excluding topical agents.
  • Have ahd prior ipilimumab with the exception of adjuvant treatment completed ≥ 6 months prior to enrollment.
  • Have had systemic treatment with IFN-α within the previous 6 months.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Melanoma and Soft Tissue
Contact Phone: 
(312) 942-5526
Contact Name: 
Pam Sroka, BS, MT(ASCP), BSN, RN, CCRC