SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides
Status:
Terminated
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
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.