SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides

Official Title

SOLAR: A Phase 2, Randomized, Open-label, Parallel-group, Active Comparator, Multi-centre Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype

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, disease-associated symptoms, and quality of life, 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 a separate clinical trial (MRG106-11-203 or PRISM), if they meet the entry criteria for that study.

Trial Description

Primary Outcome:

• Proportion of subjects achieving an objective response of at least 4 months duration (ORR4)

Secondary Outcome:

• Progression-free survival
• Pruritus Numerical Rating Scale
• Skindex-29 Dermatological Survey
• Pain Numerical Rating Scale
• Difference in drug tolerability by Patient Impression of Treatment Side Effects
• Duration of composite global response for responding subjects
• Complete response rate
• Skin disease severity based on modified Severity-weighted Assessment Tool (mSWAT)
• Time to progression
• Overall survival
• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
• Plasma concentration of cobomarsen

Study Design: Subjects will be randomly assigned in a 1:1 ratio to receive either cobomarsen or vorinostat. A total of 126 subjects (63 per arm) will be enrolled. Cobomarsen will be administered in the clinic by 2-hr intravenous infusion on Days 1, 3, 5 and 8, and weekly thereafter. Vorinostat will be dispensed to study subjects and taken as a daily oral dose according to the manufacturer's labeled dosing instructions. Treatment will continue until the subject becomes intolerant, develops clinically significant side effects, progresses, or the trial is terminated.

View this trial on ClinicalTrials.gov