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PRISM: Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Mycosis Fungoides Who Have Completed the SOLAR Study (PRISM)

Primary Purpose

Cutaneous T-Cell Lymphoma/Mycosis Fungoides

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cobomarsen
Sponsored by
miRagen Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous T-Cell Lymphoma/Mycosis Fungoides focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic Hospital
  • Dana-Farber Cancer Institute
  • Washington University School of Medicine
  • The Ohio State University and Wexner Medical Center
  • University of Washington/Seattle Cancer Care Alliance
  • University Hospital Leuven
  • Hopital Saint Andre, CHU de Bordeaux
  • Hopital Saint-Louis
  • Hopital Charles Nicolle, CHU de Rouen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cobomarsen

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Progression-free survival
Time from date of first dose of cobomarsen until the date of earliest documented progression or death from any cause.
Pruritis Numerical Rating Scale
Measures the patient's degree of itch related to mycosis fungoides based on an 11-point scale (from 0-10), with 0 being no itch and 10 being worst imaginable itch.
Skindex-29 Dermatological Survey
Measures the effects of skin disease on quality of life based on a 30-item questionnaire. The patient's responses are transformed to a linear scale from 0 to 100 and averaged to determine a subscore in three domains (Symptoms, Emotions and Functioning), as well as a total score. Lower scores indicate a lesser degree of skin disease interference with quality of life.
Pain Numerical Rating Scale
Measures the patient's intensity of pain related to mycosis fungoides based on an 11-point scale (from 0-10), with 0 being no pain and 10 being worst imaginable pain.
Difference in drug tolerability by Patient Impression of Treatment Side Effects
Duration of composite global response for responding subjects
Complete response rate
Based on composite global response criteria including radiological imaging, flow cytometry, and mSWAT.
Skin disease severity based on modified Severity-weighted Assessment Tool (mSWAT)
Measures skin disease severity based on the percentage of skin within each body region with patches, plaques, or tumors. Total scores are calculated by adding the total percent for each category of lesion (patch, plaque, or tumor) and multiplying by a weighting factor. Weighted subtotals are added together to obtain the total score. Lower scores indicate a lower degree of skin disease severity.
Time to progression
Time from date of first dose of cobomarsen until the earliest date of confirmed progression.
Overall survival
Time from date of first dose of cobomarsen until the date of death from any cause.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Plasma concentration of cobomarsen
Sparse pharmacokinetic samples will be collected to monitor for accumulation of cobomarsen.

Full Information

First Posted
February 8, 2019
Last Updated
November 17, 2020
Sponsor
miRagen Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03837457
Brief Title
PRISM: Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Mycosis Fungoides Who Have Completed the SOLAR Study
Acronym
PRISM
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Study no longer needed because eligible subjects may receive treatment with cobomarsen in a crossover arm of the SOLAR clinical trial (NCT03713320)
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
July 24, 2020 (Actual)
Study Completion Date
July 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
miRagen Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cobomarsen
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cobomarsen
Other Intervention Name(s)
MRG-106
Intervention Description
At least weekly intravenous infusions of cobomarsen (282 mg) throughout study treatment period
Primary Outcome Measure Information:
Title
Proportion of subjects achieving an objective response of at least 4 months duration (ORR4)
Description
Based on composite global response criteria including radiological imaging, flow cytometry, and the modified Severity Weighted Assessment Tool (mSWAT).
Time Frame
Up to approximately 36 months (estimated study duration)
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Time from date of first dose of cobomarsen until the date of earliest documented progression or death from any cause.
Time Frame
Up to approximately 36 months (estimated study duration)
Title
Pruritis Numerical Rating Scale
Description
Measures the patient's degree of itch related to mycosis fungoides based on an 11-point scale (from 0-10), with 0 being no itch and 10 being worst imaginable itch.
Time Frame
Daily for up to 6 months, then weekly up to approximately 36 months (estimated study duration)
Title
Skindex-29 Dermatological Survey
Description
Measures the effects of skin disease on quality of life based on a 30-item questionnaire. The patient's responses are transformed to a linear scale from 0 to 100 and averaged to determine a subscore in three domains (Symptoms, Emotions and Functioning), as well as a total score. Lower scores indicate a lesser degree of skin disease interference with quality of life.
Time Frame
Monthly, up to approximately 36 months (estimated study duration)
Title
Pain Numerical Rating Scale
Description
Measures the patient's intensity of pain related to mycosis fungoides based on an 11-point scale (from 0-10), with 0 being no pain and 10 being worst imaginable pain.
Time Frame
Daily, for up to 6 months, then weekly up to approximately 36 months (estimated study duration)
Title
Difference in drug tolerability by Patient Impression of Treatment Side Effects
Time Frame
Weekly, up to approximately 36 months (estimated study duration)
Title
Duration of composite global response for responding subjects
Time Frame
Up to approximately 36 months (estimated study duration)
Title
Complete response rate
Description
Based on composite global response criteria including radiological imaging, flow cytometry, and mSWAT.
Time Frame
Up to approximately 36 months (estimated study duration)
Title
Skin disease severity based on modified Severity-weighted Assessment Tool (mSWAT)
Description
Measures skin disease severity based on the percentage of skin within each body region with patches, plaques, or tumors. Total scores are calculated by adding the total percent for each category of lesion (patch, plaque, or tumor) and multiplying by a weighting factor. Weighted subtotals are added together to obtain the total score. Lower scores indicate a lower degree of skin disease severity.
Time Frame
Monthly, up to approximately 36 months (estimated study duration)
Title
Time to progression
Description
Time from date of first dose of cobomarsen until the earliest date of confirmed progression.
Time Frame
Up to approximately 36 months (estimated study duration)
Title
Overall survival
Description
Time from date of first dose of cobomarsen until the date of death from any cause.
Time Frame
Up to approximately 36 months (estimated study duration)
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
Up to approximately 36 months (estimated study duration)
Title
Plasma concentration of cobomarsen
Description
Sparse pharmacokinetic samples will be collected to monitor for accumulation of cobomarsen.
Time Frame
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 Pre-specified Outcome Measures:
Title
Number of participants with anti-drug antibody generation
Time Frame
Up to approximately 36 months (estimated study duration)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana M. Escolar, MD, FAAN
Organizational Affiliation
miRagen Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
The Ohio State University and Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Washington/Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University Hospital Leuven
City
Leuven
ZIP/Postal Code
B3000
Country
Belgium
Facility Name
Hopital Saint Andre, CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Charles Nicolle, CHU de Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PRISM: Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Mycosis Fungoides Who Have Completed the SOLAR Study

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