A Study to Evaluate the Effectiveness and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects with Mycosis Fungoides

Overview

About this study

The primary purpose of this study is to evaluate the effectiveness 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Nabila Bennani, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Aaron Mangold, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Jason Sluzevich, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions