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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 9
- 主要终点
- Proportion of subjects achieving an objective response of at least 4 months duration (ORR4)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have participated in the comparator arm of the SOLAR clinical trial and completed the study (confirmed disease progression).
排除标准
- •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
- •Any CTCL systemic therapy after completion of the SOLAR study and prior to Day 1 for PRISM.
研究组 & 干预措施
Cobomarsen
干预措施: Cobomarsen (Drug)
结局指标
主要结局
Proportion of subjects achieving an objective response of at least 4 months duration (ORR4)
时间窗: 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).
次要结局
- Progression-free survival(Up to approximately 36 months (estimated study duration))
- Pruritis Numerical Rating Scale(Daily for up to 6 months, then weekly up to approximately 36 months (estimated study duration))
- Skindex-29 Dermatological Survey(Monthly, up to approximately 36 months (estimated study duration))
- Pain Numerical Rating Scale(Daily, for up to 6 months, then weekly up to approximately 36 months (estimated study duration))
- Difference in drug tolerability by Patient Impression of Treatment Side Effects(Weekly, up to approximately 36 months (estimated study duration))
- Time to progression(Up to approximately 36 months (estimated study duration))
- Duration of composite global response for responding subjects(Up to approximately 36 months (estimated study duration))
- Skin disease severity based on modified Severity-weighted Assessment Tool (mSWAT)(Monthly, up to approximately 36 months (estimated study duration))
- Complete response rate(Up to approximately 36 months (estimated study duration))
- Overall survival(Up to approximately 36 months (estimated study duration))
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Up to approximately 36 months (estimated study duration))
- Plasma concentration of cobomarsen(Day 1, Day 29 and monthly or every other month thereafter until End of Treatment visit, up to approximately 36 months (estimated study duration))