Study of Cobomarsen(MRG-106) vs Active Comparator in Mycosis Fungoides
Research type
Research Study
Full title
SOLAR: A Phase 2, Randomized, Open-label, Parallel-group, Active Comparator, Multi-center Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) in Subjects with Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype
IRAS ID
251134
Contact name
Julia Scarisbrick
Contact email
Sponsor organisation
miRagen Therapeutics, Inc.
Eudract number
2018-000727-13
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Mycosis fungoides (MF) is the most common form of cutaneous T-cell lymphoma. Cutaneous T-cell lymphomas occur when certain white blood cells, called T cells, become cancerous; these cancers characteristically affect the skin, causing different types of skin lesions. MF typically affects older adults (median age of diagnosis:55 to 60 years) and may progress slowly through several stages in which skin lesions appear (patches and plaques), or are concurrent with the formation of tumours. In some late tumour-stage cases, the cancerous T cells can spread to other organs, including the lymph nodes, spleen, liver, and lungs.
Spread to other organs can occur in any stage of mycosis fungoides, but is most common in the tumour stage. In addition, affected individuals have an increased risk of developing another lymphoma or other type of cancer. Currently there are no therapies that cure or prolong the survival of late-stage CTCL patients
In this study we are looking at a drug called cobomarsen (MRG-106), which is an antagonist of miR-155-5p. Cobomarsen belongs to a class of drugs called micro-RNA inhibitors and is intended to enter the cancer cells and block the activity of another molecule called miR-155-5p, which may be important for the cancer cells to live and divide.
This study will investigate if cobomarsen (investigational drug, which is a micro-RNA inhibitor) is an effective treatment for patients with mycosis fungoides versus treatment with vorinostat (active comparator drug).As a secondary purpose of the study, we will test the safety and tolerability of cobomarsen in subjects with MF; test how cobomarsen is broken down by the human body; and test the effects of cobomarsen on the body of subjects through blood tests. The study will recruit 126 subjects with MF (with stages IB, II, or III and at least one prior therapy), from 60 hospitals around the world, with 30 sites in Europe. The study will last around 3 years.REC name
HSC REC A
REC reference
18/NI/0195
Date of REC Opinion
11 Dec 2018
REC opinion
Further Information Favourable Opinion