Illuminate 301

A Randomized Phase 3 Comparison of IMO-2125 With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)

Objective

Primary Objective:
Compare the efficacy (measured by overall survival [OS] and overall response rate [ORR]) of intratumoral IMO-2125 in combination with ipilimumab versus ipilimumab alone.

Secondary Objective: 
Assess other measures of clinical benefit, safety, pharmacokinetics (PK), and patient-reported outcomes (PROs).

Study Arms

  • Experimental: Arm A: ipilimumab
  • Experimental: Arm B: IMO-2125 plus ipilimumab

Eligibility

  • Subjects must 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
  • Patients must have confirmed progression during or after treatment with either nivolumab or Pembrolizumab
  • Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1

NCT ID

NCT03445533