Clinical trial NCT03837457: PRISM: Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Mycosis Fungoides Who Have Completed the SOLAR Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cutaneous T-Cell Lymphoma/Mycosis Fungoides
Keywords: PRISM
Cutaneous T-cell Lymphoma
CTCL
Mycosis Fungoides
Lymphoma
Lymphoma, T-cell
Lymphoma, T-cell, cutaneous
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms
MicroRNAs
Lead sponsor: miRagen Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Study Design:

Up to 60 subjects are expected to be enrolled after discontinuation from the SOLAR clinical study (MRG106-11-201). Cobomarsen will be administered in the clinic by 2-hr intravenous infusion on Days 1, 3, 5 and 8, and weekly thereafter. Treatment will continue until the subject becomes intolerant, develops clinically significant side effects, progresses, or the trial is terminated.

Eligibility criteria: Key Inclusion Criteria:

* Must have participated in the comparator arm of the SOLAR clinical trial and completed the study (confirmed disease progression).

Key Exclusion Criteria:

* 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.

Primary outcomes:
measure: Proportion of subjects achieving an objective response of at least 4 months duration (ORR4)
timeFrame: Up to approximately 36 months (estimated study duration)
Secondary outcomes:
measure: Progression-free survival
timeFrame: Up to approximately 36 months (estimated study duration)
measure: Pruritis Numerical Rating Scale
timeFrame: Daily for up to 6 months, then weekly up to approximately 36 months (estimated study duration)
measure: Skindex-29 Dermatological Survey
timeFrame: Monthly, up to approximately 36 months (estimated study duration)
measure: Pain Numerical Rating Scale
timeFrame: Daily, for up to 6 months, then weekly up to approximately 36 months (estimated study duration)
measure: Difference in drug tolerability by Patient Impression of Treatment Side Effects
timeFrame: Weekly, up to approximately 36 months (estimated study duration)
measure: Duration of composite global response for responding subjects
timeFrame: Up to approximately 36 months (estimated study duration)
measure: Complete response rate
timeFrame: Up to approximately 36 months (estimated study duration)
measure: Skin disease severity based on modified Severity-weighted Assessment Tool (mSWAT)
timeFrame: Monthly, up to approximately 36 months (estimated study duration)
measure: Time to progression
timeFrame: Up to approximately 36 months (estimated study duration)
measure: Overall survival
timeFrame: Up to approximately 36 months (estimated study duration)
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: Up to approximately 36 months (estimated study duration)
measure: Plasma concentration of cobomarsen
timeFrame: Day 1, Day 29 and monthly or every other month thereafter until End of Treatment visit, up to approximately 36 months (estimated study duration)
Other outcomes:
measure: Number of participants with anti-drug antibody generation
timeFrame: Up to approximately 36 months (estimated study duration)
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Columbus
country: United States
facility: The Ohio State University and Wexner Medical Center
state: Ohio
city: Seattle
country: United States
facility: University of Washington/Seattle Cancer Care Alliance
state: Washington
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Bordeaux
country: France
facility: Hopital Saint Andre, CHU de Bordeaux
city: Paris
country: France
facility: Hopital Saint-Louis
city: Rouen
country: France
facility: Hopital Charles Nicolle, CHU de Rouen
Study officials:
affiliation: miRagen Therapeutics, Inc.
name: Diana M. Escolar, MD, FAAN
role: STUDY_DIRECTOR
References: