2023-504515-33-00招募中2 期
A Phase 2 Open-label, Two-cohort Study to Evaluate Patient Preference for nivolumab + relatlimab Fixed-dose Combination Subcutaneous versus nivolumab + relatlimab Fixed-dose Combination Intravenous and nivolumab Subcutaneous versus nivolumab Intravenous in Participants with Melanoma
Bristol-Myers Squibb Services Unlimited Company19 个研究点 分布在 3 个国家目标入组 82 人开始时间: 2024年1月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 19
- 主要终点
- The main endpoint in both groups is the percentage of participants who prefer having the treatment given as SC more than as IV.
研究概览
简要总结
The main objective in both groups is to see if participants prefer their drug to be given to them one way (SC) or the other way (IV).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •The study population will be made up of men and women (who are not pregnant or breastfeeding) 18 years of age or older that have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease. Participants must have a low level of disability and cancer that is considered advanced for metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for resected melanoma.
排除标准
- •Participants must not have any brain cancer/disease treated with radiation, any cancer in the eyes or mucous membranes (cells that cover inside surface of parts of the body and keep it moist), any autoimmune disease, or any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body’s immune system response (immunosuppressive drugs).
结局指标
主要结局
The main endpoint in both groups is the percentage of participants who prefer having the treatment given as SC more than as IV.
The main endpoint in both groups is the percentage of participants who prefer having the treatment given as SC more than as IV.
次要结局
- The secondary endpoint in both groups is to see the side effects and abnormal laboratory tests during the study.
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (19)
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