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

Trial Status: Active

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.

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

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

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Amitkumar N. Mehta
Phone: 205-996-8400

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: ACTIVE

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: IN_REVIEW
Contact: April Johnson
Phone: 949-653-2959ext118
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: APPROVED

Florida

Jacksonville
Mayo Clinic in Florida
Status: ACTIVE
Tampa
Moffitt Cancer Center
Status: ACTIVE

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: IN_REVIEW

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: ACTIVE

Minnesota

Rochester
Mayo Clinic
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: APPROVED

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

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.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
miRagen Therapeutics, Inc.

  • Primary ID MRG106-11-201
  • Secondary IDs NCI-2018-02724, 2018-000727-13
  • Clinicaltrials.gov ID NCT03713320