SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides
Condition: Cutaneous T-Cell Lymphoma/Mycosis Fungoides
MeSH terms: Mycoses; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Mycosis Fungoides; Lymphoma, T-Cell, Cutaneous
Intervention: Cobomarsen; Vorinostat
Intervention description: At least weekly doses of cobomarsen (282 mg) throughout study treatment period; Daily doses of vorinostat throughout study treatment period
Intervention MeSH terms: Vorinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SOLAR; Cutaneous T-cell Lymphoma; CTCL; Mycosis Fungoides; Lymphoma; Lymphoma, T-cell; Lymphoma, T-cell, cutaneous; Lymphoma, Non-Hodgkin; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms; MicroRNAs; Vorinostat; Histone Deacetylase Inhibitors

Summary:

      The main objective of this clinical trial is to study the efficacy and safety of cobomarsen
      (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis
      fungoides (MF) subtype. Cobomarsen is designed to inhibit the activity of a molecule called
      miR-155 that may be important to the growth and survival of MF cancer cells. The study will
      compare the effects of cobomarsen to vorinostat, a drug that has been approved for the
      treatment of CTCL in the United States and several other countries.

      Participants in the clinical trial will be randomly assigned to receive either weekly doses
      of cobomarsen by injection into a vein or daily oral doses of vorinostat. Participants will
      continue on their assigned treatment as long as there is no evidence of progression of their
      cancer. The effects of treatment will be measured based on changes in skin lesion severity,
      as well as the length of time that the subject's disease remains stable or improved, without
      evidence of disease progression. The safety and tolerability of cobomarsen will be assessed
      based on the frequency and severity of observed side effects.

      Participants assigned to receive vorinostat who experience progression of their disease
      during their participation in this study may have the option to be treated with cobomarsen in
      an open-label, crossover arm of the same study if they meet the entry criteria for that part
      of the study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Biopsy-proven CTCL, MF subtype

          -  Clinical stage IB, II, or III, with staging based on screening assessments

          -  Minimum mSWAT score of 10 at screening

          -  Receipt of at least one prior therapy for CTCL

        Key Exclusion Criteria:

          -  Previous enrollment in a cobomarsen study

          -  Prior therapy with vorinostat or other HDAC inhibitors, or contraindication to an HDAC
             inhibitor

          -  Sézary syndrome or mycosis fungoides with B2 involvement, defined as documented
             history of B2 and/or B2 staging at screening

          -  Evidence of large cell transformation

          -  Lymph node involvement at screening, unless radiologically or histologically confirmed
             to be nonmalignant

          -  Visceral involvement related to MF at screening