The purpose of this study is to test a new investigational drug (one that is not approved by the US Food and Drug Administration) called cobomarsen (MRG-106). 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. Cobomarsen’s effect on mycosis fungoides will be compared in this study with the effect of vorinostat, which is a drug that has been approved in the United States and Australia for treatment of CTCL. Vorinostat has not been approved in Europe and would be considered an investigational drug in Europe.
Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital
- Biopsy-proven CTCL, MF subtype
- Clinical stage IB, II, or III, with staging based on Screening assessments and following staging parameters set in the protocol
- Receipt of at least one prior therapy for CTCL (per National Comprehensive Cancer Network [NCCN] guidelines for generalized skin involvement; e.g., topical, phototherapy, total skin electron beam therapy [TSEBT], or systemic therapy
- Calculated creatinine clearance ≥ 40 mL/min using 24-hour creatinine clearance OR modified Cockcroft-Gault equation (using ideal body mass [IBM] instead of mass)
- AST and ALT ≤ 2.5 × the ULN; bilirubin ≤ 1.5 × ULN (except subjects with Gilbert’s Syndrome who may have bilirubin ≤ 3.0 × ULN following discussion with the Sponsor)
- Additional eligibility in protocol
- 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 a documented history of B2 and/or B2 staging at the screening visit
- Evidence of large cell transformation
- Evidence of enlarged peripheral or central lymph node(s) > 1.5 cm in the long diameter or > 1.0 cm in the short diameter by radiographical imaging at screening. A subject with one or more enlarged lymph node(s) may be allowed, provided that a representative lymph node has been confirmed to be nonmalignant (N0-N1) within the 3 months prior to Day 1, and there has not been an appearance of new abnormal lymph nodes since the biopsy
- Any palpable peripheral node, regardless of size, that on physical examination is firm, irregular, clustered, or fixed, unless histologically confirmed to be non-malignant
- Evidence of visceral involvement related to MF at screening.
- Recent history of alcoholism (within the past 1 year)
- Known or suspected substance abuse (within the past 1 year)
- Unresolved toxicities from prior anticancer therapy
- Additional ineligibility in protocol
For more information, go to: https://clinicaltrials.gov/ct2/show/NCT03713320