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Idera 2125-MEL-301: A randomized Phase 3 comparison of IMO-2125 with ipilimumab versus ipilimumab alone in subjects with anti-PD-1 refractory melanoma (ILLUMINATE-301)


This is a phase 3 global, multi-center, open-label comparison of ipilimumab with and without intratumoral IMO-2125 in subjects with advanced melanoma who had confirmed disease progression while on nivolumab or pembrolizumab.


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Primary Study Objective(s)

The primary objective is to compare the efficacy of IMO-2125 in combination with ipilimumab versus ipilimumab alone.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • 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

In addition, all the following must apply:

  • No intervening anti-cancer therapy between the last course of nivolumab or pembrolizumab and the first dose of the study treatment except for local measures (e.g., surgical excision or biopsy, focal radiation therapy).
  • The interval between the last nivolumab or pembrolizumab and the start of the study treatment should be at least 21 days with no residual anti-PD-1-related immune toxicities in excess of grade 1 severity.
  • If BRAF mutation status is unknown, before randomization the subject must have BRAF testing performed using an approved assay method.
  • Patients with BRAF-positive tumor(s) are eligible for the study if they received prior treatment with a BRAF inhibitor (alone of in combination with a MEK inhibitor) or declined targeted therapy.
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status.
  • Patients must meet protocol-defined laboratory criteria.

Excluding patients who:

  • Have ocular melanoma
  • Have had prior therapy with a toll-like receptor (TLR) agonist, excluding topical agents
  • Have had prior ipilimumab treatment with the exception of adjuvant treatment completed at least six months prior to enrollment
  • Have had systemic treatment with interferon (IFN) within the previous six months
  • Have a known hypersensitivity to any oligodeoxynucleotide
  • Have an active autoimmune disease requiring disease-modifying therapy at the time of screening
  • Have required systemic steroid therapy should be receiving ≤ 10 mg/day of prednisone (or equivalent) for the two   weeks preceding start of study
  • Have another primary malignancy that has not been in remission for at least three years, with the exception of non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in situ on a biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic)
  • Have an active systemic infection(s) requiring antibiotics
  • Have an active hepatitis A, B or C infection
  • Have a known diagnosis of human immunodeficiency virus (HIV) infection
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