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

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ClinicalTrials.gov Identifier: NCT03837457
Recruitment Status : Enrolling by invitation
First Posted : February 12, 2019
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
miRagen Therapeutics, Inc.

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.


Condition or disease Intervention/treatment Phase
Cutaneous T-Cell Lymphoma/Mycosis Fungoides Drug: Cobomarsen Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: Cobomarsen Drug: Cobomarsen
At least weekly intravenous infusions of cobomarsen (282 mg) throughout study treatment period
Other Name: MRG-106




Primary Outcome Measures :
  1. Proportion of subjects achieving an objective response of at least 4 months duration (ORR4) [ Time Frame: Up to approximately 36 months (estimated study duration) ]
    Based on composite global response criteria including radiological imaging, flow cytometry, and the modified Severity Weighted Assessment Tool (mSWAT).


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Up to approximately 36 months (estimated study duration) ]
    Time from date of first dose of cobomarsen until the date of earliest documented progression or death from any cause.

  2. Pruritis Numerical Rating Scale [ Time Frame: Daily for up to 6 months, then weekly up to approximately 36 months (estimated study duration) ]
    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.

  3. Skindex-29 Dermatological Survey [ Time Frame: Monthly, up to approximately 36 months (estimated study duration) ]
    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.

  4. Pain Numerical Rating Scale [ Time Frame: Daily, for up to 6 months, then weekly up to approximately 36 months (estimated study duration) ]
    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.

  5. Difference in drug tolerability by Patient Impression of Treatment Side Effects [ Time Frame: Weekly, up to approximately 36 months (estimated study duration) ]
  6. Duration of composite global response for responding subjects [ Time Frame: Up to approximately 36 months (estimated study duration) ]
  7. Complete response rate [ Time Frame: Up to approximately 36 months (estimated study duration) ]
    Based on composite global response criteria including radiological imaging, flow cytometry, and mSWAT.

  8. Skin disease severity based on modified Severity-weighted Assessment Tool (mSWAT) [ Time Frame: Monthly, up to approximately 36 months (estimated study duration) ]
    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.

  9. Time to progression [ Time Frame: Up to approximately 36 months (estimated study duration) ]
    Time from date of first dose of cobomarsen until the earliest date of confirmed progression.

  10. Overall survival [ Time Frame: Up to approximately 36 months (estimated study duration) ]
    Time from date of first dose of cobomarsen until the date of death from any cause.

  11. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Up to approximately 36 months (estimated study duration) ]
  12. Plasma concentration 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) ]
    Sparse pharmacokinetic samples will be collected to monitor for accumulation of cobomarsen.


Other Outcome Measures:
  1. Number of participants with anti-drug antibody generation [ Time Frame: Up to approximately 36 months (estimated study duration) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837457


Locations
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Sponsors and Collaborators
miRagen Therapeutics, Inc.
Investigators
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Study Director: Diana M. Escolar, MD, FAAN miRagen Therapeutics, Inc.
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Responsible Party: miRagen Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03837457    
Other Study ID Numbers: MRG106-11-203
2018-003748-22 ( EudraCT Number )
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by miRagen Therapeutics, Inc.:
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
Additional relevant MeSH terms:
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Mycoses
Lymphoma
Lymphoma, T-Cell
Mycosis Fungoides
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin