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
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 62
- 主要终点
- Number of participants that prefer subcutaneous (SC) route of administration as assessed by Question 7 of the Patient Experience and Preference Questionnaire (PEPQ)
研究概览
简要总结
The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 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
- •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
- •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)
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Cohort 1: Metastatic Melanoma
干预措施: relatlimab+nivolumab+rHuPH20 (Drug)
Cohort 1: Metastatic Melanoma
干预措施: relatlimab+nivolumab (Drug)
Cohort 2: Resected Melanoma
干预措施: nivolumab (Drug)
Cohort 2: Resected Melanoma
干预措施: nivolumab+rHuPH20 (Drug)
结局指标
主要结局
Number of participants that prefer subcutaneous (SC) route of administration as assessed by Question 7 of the Patient Experience and Preference Questionnaire (PEPQ)
时间窗: At Cycle 4 Day 1 (each cycle is 28 days)
Percentage of Evaluable Participants That Prefer SC Route of Administration Using the Patient Experience and Preference Questionnaire (PEPQ) (Question 7) After Cycle 4 Day 1 Dose
时间窗: Cycle 4 Day 1 (each cycle consist of 4 weeks)
PEPQ included 7 items 1. Pain or Discomfort (rated on 1 to 10 scale), 2. Length of time related to administration 3. Length of time related to administration impact amount of time to speak to doctor or nurse about illness or concern 4. Length of time for administration impact time to interact or socialize with other individuals 5. Convenience 6. Satisfaction 7. Choice of which route of administration would be preferred. 95% CI exact confidence interval was reported.
次要结局
- Number of participants with Immune-mediated AEs (IMAEs)(Up to approximately 2.5 years)
- Number of deaths(Up to approximately 2.5 years)
- Number of participants with Adverse Events (AEs)(Up to approximately 2.5 years)
- Number of participants with AEs leading to discontinuation(Up to approximately 2.5 years)
- Number of participants with injection/infusion-related AEs(Up to approximately 2.5 years)
- Number of participants with Serious AEs (SAEs)(Up to approximately 2.5 years)
- Number of participants with other events of special interest (OESIs)(Up to approximately 2.5 years)
- Number of participants with laboratory abnormalities(Up to approximately 2.5 years)
- Number of participants with treatment-related AEs(Up to approximately 2.5 years)
- Number of Participants With Adverse Events and Deaths(First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 16 months))
- Number of Participants With Laboratory Abnormalities and Immune Mediate Adverse Event(From first dose (Day 1) and up to study completion (up to approximately 45 months))