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

Status:	Recruiting
Conditions:	Infectious Disease, Lymphoma
Therapuetic Areas:	Immunology / Infectious Diseases, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	2/14/2019
Start Date:	September 12, 2018
End Date:	September 2021

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

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.

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.

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

We found this trial at

sites

Moffitt Cancer Center

Tampa, Florida 33612

Principal Investigator: Lubomir Sokol, MD, PhD

Phone: 813-745-1706

from

Tampa, FL