Description:
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.
Title
- Brief Title: SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides
- Official 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
Clinical Trial IDs
- ORG STUDY ID:
MRG106-11-201
- SECONDARY ID:
2018-000727-13
- NCT ID:
NCT03713320
Conditions
- Cutaneous T-Cell Lymphoma/Mycosis Fungoides
Interventions
| Drug | Synonyms | Arms |
|---|
| Cobomarsen | MRG-106 | Cobomarsen |
| Vorinostat | | Vorinostat |
Purpose
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.
Detailed Description
Study Design:
Subjects will be randomly assigned in a 1:1 ratio to receive either cobomarsen or vorinostat.
Approximately 126 subjects (63 per arm) are expected to be enrolled. Cobomarsen will be
administered in the clinic by 2-hr intravenous infusion on Days 1, 3, 5 and 8, and weekly
thereafter. Vorinostat will be dispensed to study subjects and taken as a daily oral dose
according to the manufacturer's labeled dosing instructions. Treatment will continue until
the subject becomes intolerant, develops clinically significant side effects, progresses, or
the trial is terminated. An interim analysis will be conducted after approximately 40
subjects have been followed for a minimum of approximately 6 months. Enrollment will be
suspended until the completion of the interim analysis.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Cobomarsen | Experimental | | |
| Vorinostat | Active Comparator | | |
Eligibility Criteria
Key Inclusion Criteria:
- 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
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Proportion of subjects achieving an objective skin response of at least 4 months duration (ORR4) |
| Time Frame: | Up to approximately 36 months (estimated study duration) |
| Safety Issue: | |
| Description: | Based on the modified Severity Weighted Assessment Tool (mSWAT) which 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. |
Secondary Outcome Measures
| Measure: | Progression-free survival |
| Time Frame: | Up to approximately 36 months (estimated study duration) |
| Safety Issue: | |
| Description: | Time from date of randomization until the date of earliest documented progression or death from any cause |
| Measure: | Complete response rate |
| Time Frame: | Up to approximately 36 months (estimated study duration) |
| Safety Issue: | |
| Description: | Based on mSWAT. |
| Measure: | Skin disease severity based on mSWAT |
| Time Frame: | Monthly up to Week 81, then every other week up to approximately 36 months (estimated study duration) |
| Safety Issue: | |
| Description: | |
| Measure: | Time to progression |
| Time Frame: | Up to approximately 36 months (estimated study duration) |
| Safety Issue: | |
| Description: | Time from date of randomization until the earliest date of confirmed progression. |
| Measure: | Pruritus medication utilization |
| Time Frame: | From Day 1 to End of Treatment visit, up to approximately 36 months (estimated study duration) |
| Safety Issue: | |
| Description: | |
| Measure: | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
| Time Frame: | Up to approximately 36 months (estimated study duration) |
| Safety Issue: | |
| Description: | |
| Measure: | Plasma concentration of cobomarsen |
| Time Frame: | From Day 1 to End of Treatment visit, up to approximately 36 months (estimated study duration) |
| Safety Issue: | |
| Description: | Sparse pharmacokinetic samples will be collected for the purpose of population PK model development and analysis of covariate effects. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Terminated |
| Lead Sponsor: | miRagen Therapeutics, Inc. |
Trial Keywords
- SOLAR
- 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
- Vorinostat
- Histone Deacetylase Inhibitors
Last Updated
December 14, 2020
