SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides (SOLAR)
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|ClinicalTrials.gov Identifier: NCT03713320|
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : December 11, 2018
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, Canada, and Australia.
Participants will be randomly assigned to receive either weekly doses of cobomarsen or daily doses of vorinostat. Participants will continue on their assigned treatment as long as their disease does not get worse or as long as they do not have unacceptable side effects. 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.
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 a separate clinical trial, if they meet the entry criteria for that study.
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous T-Cell Lymphoma/Mycosis Fungoides||Drug: Cobomarsen Drug: Vorinostat||Phase 2|
Subjects will be randomly assigned in a 1:1 ratio to receive either cobomarsen or vorinostat. A total of 126 subjects (63 per arm) will be enrolled. Cobomarsen will be administered in the clinic by 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 12, 2018|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||September 2021|
At least weekly doses of cobomarsen throughout study treatment period
Other Name: MRG-106
Active Comparator: Vorinostat
Daily doses of vorinostat throughout study treatment period
- Proportion of subjects achieving an objective response of at least 4 months duration (ORR4) [ Time Frame: Up to 36 months ]Based on composite global response criteria including radiological imaging, flow cytometry, and the modified Severity Weighted Assessment Tool (mSWAT).
- Progression-free survival [ Time Frame: From date of randomization until the date of progression or death from any cause, up to a maximum of 36 months ]
- Pruritus Numerical Rating Scale [ Time Frame: Daily, up to a maximum of 36 months ]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 [ Time Frame: Monthly, up to a maximum of 36 months ]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 [ Time Frame: Daily, up to a maximum of 36 months ]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.
- Duration of composite global response for responding subjects [ Time Frame: Up to 36 months ]
- Complete response rate [ Time Frame: Up to 36 months ]Based on composite global response criteria including radiological imaging, flow cytometry, and mSWAT.
- Skin disease severity based on modified Severity-weighted Assessment Tool (mSWAT) [ Time Frame: Monthly, up to a maximum of 36 months ]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 Frame: From date of randomization until the date of progression, up to a maximum of 36 months ]
- Overall survival [ Time Frame: From date of randomization until the date of death from any cause, up to a maximum of 36 months ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Up to 36 months ]
- Plasma concentration of cobomarsen [ Time Frame: From Day 1 to End of Treatment visit, up to a maximum of 36 months ]Sparse pharmacokinetic samples will be collected for the purpose of population PK model development and analysis of covariate effects.
- Number of participants with anti-drug antibody generation [ Time Frame: Up to 36 months ]
- Change from baseline in Mycosis Fungoides/Sézary Syndrome Cutaneous T-cell Lymphoma-Quality of Life (MF/SS CTCL QOL) instrument [ Time Frame: Up to 36 months ]Measures the impact of CTCL on patients' quality of life based on a 12-item questionnaire. The patient's total scaled score is determined from the sum of the 12 item scores and may range from 62 to 154. Lower scores indicate a lesser degree of CTCL disease interference with quality of life.
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): NCT03713320
|United States, California|
|City of Hope||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Rosemarie Abary 626-218-8087 firstname.lastname@example.org|
|Principal Investigator: Christiane Querfeld, MD|
|Chao Family Comprehensive Cancer Center at University of California, Irvine||Recruiting|
|Orange, California, United States, 92868|
|Contact: Blake Johnson 714-456-3476 Blakej@uci.edu|
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|United States, Connecticut|
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|Saint Louis, Missouri, United States, 63108|
|Contact: Mary Tabacchi, CCRC 314-362-8171 email@example.com|
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|United States, New York|
|Rochester Skin Lymphoma Medical Group||Not yet recruiting|
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|Principal Investigator: Brian Poligone, MD, PhD|
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|Principal Investigator: Basem William, MD|
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|Principal Investigator: Minakshi Taparia, MD|
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|Principal Investigator: Vishal Kukreti, MD|
|Jewish General Hospital||Not yet recruiting|
|Montréal, Quebec, Canada, H3T 1E2|
|Principal Investigator: Kevin Pehr, MD|
|Study Director:||Diana Escolar, MD||miRagen Therapeutics, Inc.|