Study Stopped
Study no longer needed because eligible subjects may receive treatment with cobomarsen in a crossover arm of the SOLAR clinical trial (NCT03713320)
PRISM: Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Mycosis Fungoides Who Have Completed the SOLAR Study
PRISM
PRISM: An Open-label, Multi-Center Extension Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) Following Systemic Treatment in Subjects With Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype, Who Have Completed the SOLAR Study
2 other identifiers
interventional
8
3 countries
9
Brief 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 in subjects who have confirmed disease progression following treatment with vorinostat in the SOLAR clinical study (MRG106-11-201). 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2019
Shorter than P25 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2019
CompletedFirst Posted
Study publicly available on registry
February 12, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2020
CompletedNovember 19, 2020
November 1, 2020
10 months
February 8, 2019
November 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of subjects achieving an objective response of at least 4 months duration (ORR4)
Based on composite global response criteria including radiological imaging, flow cytometry, and the modified Severity Weighted Assessment Tool (mSWAT).
Up to approximately 36 months (estimated study duration)
Secondary Outcomes (12)
Progression-free survival
Up to approximately 36 months (estimated study duration)
Pruritis Numerical Rating Scale
Daily for up to 6 months, then weekly up to approximately 36 months (estimated study duration)
Skindex-29 Dermatological Survey
Monthly, up to approximately 36 months (estimated study duration)
Pain Numerical Rating Scale
Daily, for up to 6 months, then weekly up to approximately 36 months (estimated study duration)
Difference in drug tolerability by Patient Impression of Treatment Side Effects
Weekly, up to approximately 36 months (estimated study duration)
- +7 more secondary outcomes
Other Outcomes (1)
Number of participants with anti-drug antibody generation
Up to approximately 36 months (estimated study duration)
Study Arms (1)
Cobomarsen
EXPERIMENTALInterventions
At least weekly intravenous infusions of cobomarsen (282 mg) throughout study treatment period
Eligibility Criteria
You may qualify if:
- Must have participated in the comparator arm of the SOLAR clinical trial and completed the study (confirmed disease progression).
You may not qualify if:
- 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.
- Visceral involvement related to MF at screening.
- Unresolved toxicities from prior vorinostat treatment, defined as having not resolved to CTCAE v5.0 grade 0 or 1.
- Any CTCL systemic therapy after completion of the SOLAR study and prior to Day 1 for PRISM.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Washington University School of Medicine
St Louis, Missouri, 63108, United States
The Ohio State University and Wexner Medical Center
Columbus, Ohio, 43210, United States
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
University Hospital Leuven
Leuven, B3000, Belgium
Hopital Saint Andre, CHU de Bordeaux
Bordeaux, 33076, France
Hopital Saint-Louis
Paris, 75475, France
Hopital Charles Nicolle, CHU de Rouen
Rouen, 76031, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Diana M. Escolar, MD, FAAN
miRagen Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2019
First Posted
February 12, 2019
Study Start
October 1, 2019
Primary Completion
July 24, 2020
Study Completion
July 27, 2020
Last Updated
November 19, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share