Phase 3 Randomized study for Refractory Melanoma

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

September 18, 2018

  • Clinical Trial Information

    Trial Contact: Frankos, Marie; Tan, Ciara Natasha

    Trial Phone: 321.841.7303 ; 321.841.7413

  • IRB No: 18.006.01

    Protocol Abbrev: 2125-MEL-301

    Principal Investigator: Sajeve Samuel Thomas, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: 2125-MEL-301

    Treatment: IMO-2125, Ipilimumab

    Therapies Involved: Oncology: Adjuvant

    ClinicalTrials.gov ID: NCT03445533

  • Objective

    Primary Objective:

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

    Secondary Objective:

    The secondary objectives are to assess other measures of clinical benefit, safety, PK, and patient-reported outcomes (PROs).

    Exploratory Objective:

    The exploratory objectives are to investigate potential biomarkers, including cytokines, and the incidence of anti-IMO-2125 antibodies

  • Key Eligibility

    1. Subjects must be willing and able to sign the informed consent and comply with the study protocol.
    2. Must be ≥18 years of age.
    3. 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.
    4. 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.

    a) 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).
    b) The interval between last nivolumab or pembrolizumab and start of study treatment should be at least 21 days with no residual anti-PD-1-related immune toxicities in excess of Grade 1 severity.
    c) Prior BRAF inhibitor treatment (alone or in combination with a MEK inhibitor) is required if the tumor carries a BRAF V600E or V600K mutation.
    5. ECOG Performance Status ≤1.
    6. Adequate baseline organ function as defined by:
    a) Absolute neutrophil count (ANC) ≥1.5 x 109/L (1500/mm3)
    b) Platelet count ≥100 x 109/L (100,000/mm3)
    c) Hemoglobin ≥8.0 g/dL (4.96 mmol/L)
    d) Serum creatinine ≤1.5 x upper limit of normal (ULN) or 24-hour creatinine clearance ≥60 mL/minute (≤Grade 1)
    e) Aspartate aminotransferase (AST) ≤2.5 x ULN; alanine aminotransferase (ALT) ≤2.5 x ULN; AST/ALT <5 x ULN if liver involvement (≤Grade 1)
    f) Serum bilirubin ≤1.5 x ULN, except in subjects with Gilbert’s Syndrome who must have a total bilirubin <3 mg/dL (≤Grade 1)