A Phase 3, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-Risk Stage II-IV Melanoma (INTerpath-001)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,089
- 试验地点
- 165
- 主要终点
- Recurrence-Free Survival (RFS)
研究概览
简要总结
The purpose of this study is to learn if intismeran autogene which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid [mRNA]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if intismeran autogene with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double blind
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
- •The main inclusion criteria include but are not limited to the following:
- •Has surgically resected and histologically/pathologically confirmed diagnosis of Stage IIB or IIC, III, or IV cutaneous melanoma
- •Has not received any prior systemic therapy for their melanoma beyond surgical resection
- •No more than 13 weeks have passed between final surgical resection that rendered the participant disease-free and the first dose of pembrolizumab
- •Is disease free at the time of providing documented consent for the study
- •Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has ocular or mucosal melanoma
- •Has cancer that has spread to other parts of the body and cannot be removed with surgery
- •Has heart failure within the past 6 months
- •Has received prior cancer therapy or another cancer vaccine
- •Has another known cancer that that has spread to other parts of the body or has required treatment within the past 3 years
- •Has severe reaction to study medications or any of their substance used to prepare a drug
- •Have not recovered from major surgery or have ongoing surgical complications
研究组 & 干预措施
Intismeran autogene + Pembrolizumab
Participants receive up to 9 doses of intismeran autogene via an intramuscular (IM) injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an intravenous (IV) infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner.
干预措施: Intismeran autogene (Biological)
Intismeran autogene + Pembrolizumab
Participants receive up to 9 doses of intismeran autogene via an intramuscular (IM) injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an intravenous (IV) infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner.
干预措施: Pembrolizumab (Biological)
Placebo + Pembrolizumab
Participants receive up to 9 doses of dose matched placebo to intismeran autogene via an IM injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an IV infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner.
干预措施: Pembrolizumab (Biological)
Placebo + Pembrolizumab
Participants receive up to 9 doses of dose matched placebo to intismeran autogene via an IM injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an IV infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner.
干预措施: Placebo (Other)
结局指标
主要结局
Recurrence-Free Survival (RFS)
时间窗: Up to approximately 74 months
RFS is defined as the length of time from when the participant starts the study until either the cancer comes back, or the cancer spreads as assessed by the investigator, or death due to any cause.
次要结局
- Overall-Survival (OS)(Up to approximately 85 months)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 56 weeks)
- Distant Metastasis-Free Survival (DMFS)(Up to approximately 85 months)
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 68 weeks)
- Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30(Baseline and up to approximately 85 months)
- Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30(Baseline and up to approximately 85 months)
- Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score(Baseline and up to approximately 85 months)