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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03713320
Registration number
NCT03713320
Ethics application status
Date submitted
17/10/2018
Date registered
19/10/2018
Date last updated
8/04/2022
Titles & IDs
Public title
SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides
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Scientific title
SOLAR: A Phase 2, Randomized, Open-label, Parallel-group, Active Comparator, Multi-center Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype
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Secondary ID [1]
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2018-000727-13
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Secondary ID [2]
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MRG106-11-201
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Universal Trial Number (UTN)
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Trial acronym
SOLAR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cutaneous T-Cell Lymphoma/Mycosis Fungoides
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Condition category
Condition code
Infection
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Other infectious diseases
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cobomarsen
Treatment: Drugs - Vorinostat
Experimental: Cobomarsen - Cobomarsen will be administered by intravenous 2-hour infusion at a dose of 282 mg on Days 1, 3, 5, 8, and weekly thereafter
Active Comparator: Vorinostat - Vorinostat will be administered orally at a dose of 400 mg (four 100-mg capsules) once daily with food, at approximately the same time each day.
Treatment: Drugs: Cobomarsen
At least weekly doses of cobomarsen (282 mg) throughout study treatment period
Treatment: Drugs: Vorinostat
Daily doses of vorinostat throughout study treatment period
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Subjects Achieving an Objective Skin Response of at Least 4 Months Duration (ORR4)
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Assessment method [1]
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ORR4 is the percentage of subjects with a complete response (CR) or partial response (PR) in the skin for 4 consecutive months confirmed by repeat assessments no less than 28 days (± 3 days) later. The modified Severity Weighted Assessment Tool (mSWAT) is used to measure skin disease severity based on the percentage of body surface area (BSA) with patches, plaques, or tumors. Total scores are calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores. Lower scores indicate a lower degree of skin disease severity. CR corresponds to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponds to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors.
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Timepoint [1]
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Date of first dose through the earlier of last study visit or interim analysis data cut-off date of 12-Oct-2020, up to 16 months
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Secondary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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Time from date of randomization until the date of earliest documented progression or death from any cause. The duration of PFS was censored at the date of the last mSWAT assessment if the subject was alive and had no documented progression. Disease progression in the skin is defined as = 25% increase in mSWAT score from baseline or, in participants with complete or partial response, increase in mSWAT score of greater than the sum of the nadir plus 50% baseline score.
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Timepoint [1]
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Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
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Secondary outcome [2]
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Complete Response Rate
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Assessment method [2]
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Percentage of subjects with a complete response in the skin based on mSWAT
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Timepoint [2]
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Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
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Secondary outcome [3]
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Time to Progression
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Assessment method [3]
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Time from date of randomization until the earliest date of confirmed progression
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Timepoint [3]
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Date of first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
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Secondary outcome [4]
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Time to Maximal Effect in mSWAT
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Assessment method [4]
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Time to greatest improvement in mSWAT score
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Timepoint [4]
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Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
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Secondary outcome [5]
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Objective Response Rate in the Skin of at Least 28-days Duration (ORR1)
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Assessment method [5]
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Percentage of participants achieving = 50% improvement in mSWAT of at least 28-days duration
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Timepoint [5]
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Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
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Secondary outcome [6]
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Percentage of Subjects Achieving = 50% Improvement in mSWAT at 28 Days
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Assessment method [6]
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Percentage of subjects achieving = 50% improvement from baseline in mSWAT at 28 days after first dose
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Timepoint [6]
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28 days after first dose
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Secondary outcome [7]
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Percentage of Subjects Achieving = 50% Improvement in mSWAT at 4 Months
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Assessment method [7]
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Percentage of subjects achieving = 50% improvement from baseline in mSWAT at 4 months after first dose
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Timepoint [7]
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4 months after first dose
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Secondary outcome [8]
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Time to = 50% Improvement in mSWAT
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Assessment method [8]
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Time from date of randomization until = 50% improvement in mSWAT score
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Timepoint [8]
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Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
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Secondary outcome [9]
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Duration of Response in Skin
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Assessment method [9]
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Duration of response in skin (no progression after achieving = 50% improvement in mSWAT)
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Timepoint [9]
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Monthly from first dose through interim analysis data cut-off date of 12-Oct-2020, up to 16 months
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Secondary outcome [10]
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Pruritus Medication Utilization
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Assessment method [10]
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Change from baseline in number of pruritus medications taken per subject
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Timepoint [10]
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Date of first dose through end of treatment or interim analysis data cut-off date of 12-Oct-2020, up to 16 months
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Eligibility
Key inclusion criteria
Key
- Biopsy-proven CTCL, MF subtype
- Clinical stage IB, II, or III, with staging based on screening assessments
- Minimum mSWAT score of 10 at screening
- Receipt of at least one prior therapy for CTCL
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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 documented
history of B2 and/or B2 staging at screening
- Evidence of large cell transformation
- Lymph node involvement at screening, unless radiologically or histologically confirmed
to be nonmalignant
- Visceral involvement related to MF at screening
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/04/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2020
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Sample size
Target
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Accrual to date
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Final
37
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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Westmead Hospital - Westmead
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Recruitment hospital [3]
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Linear Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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NSW 2145 - Westmead
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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Arizona
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California
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Connecticut
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Florida
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Massachusetts
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Minnesota
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Missouri
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New York
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Ohio
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Virginia
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Washington
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Belgium
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Leuven
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Canada
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Bordeaux
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France
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Paris
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France
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Pierre-Bénite
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France
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Reims
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France
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Rouen
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Italy
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Bologna
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Milano
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Torino
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Barcelona
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Madrid
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Salamanca
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Spain
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Valencia
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United Kingdom
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Birmingham
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Glasgow
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London
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United Kingdom
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
miRagen Therapeutics, Inc.
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Address
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Ethics approval
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Summary
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. 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 study will
compare the effects of cobomarsen to vorinostat, a drug that has been approved for the
treatment of CTCL in the United States and several other countries.
Participants in the clinical trial will be randomly assigned to receive either weekly doses
of cobomarsen by injection into a vein or daily oral doses of vorinostat. Participants will
continue on their assigned treatment as long as there is no evidence of progression of their
cancer. The effects of treatment will be measured based on changes in skin lesion severity,
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.
Participants assigned to receive vorinostat who experience progression of their disease
during their participation in this study may have the option to be treated with cobomarsen in
an open-label, crossover arm of the same study if they meet the entry criteria for that part
of the study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03713320
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Diana M. Escolar, MD, FAAN
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Address
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miRagen Therapeutics, Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03713320
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