A Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab Versus Pembrolizumab Alone After Complete Resection of High-Risk Melanoma (KEYNOTE- 942)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 267
- 试验地点
- 46
- 主要终点
- Recurrence-Free Survival (RFS), Assessed Using Radiological Imaging
研究概览
简要总结
The purpose of this study is to assess whether postoperative adjuvant therapy with mRNA-4157 and pembrolizumab improves recurrence free survival (RFS) compared to pembrolizumab alone in participants with complete resection of cutaneous melanoma and a high risk of recurrence.
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
- None
盲法说明
Open Label
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
- •Resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence
- •Complete resection within 13 weeks prior to the first dose of pembrolizumab
- •Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases
- •Has an formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- •Normal organ and marrow function reported at screening
排除标准
- •Prior malignancy, unless no evidence of that disease for at least 5 years prior to study entry
- •Prior systemic anti-cancer treatment (except surgery and interferon for thick primary melanomas. Radiotherapy after lymph node dissection is permitted)
- •Live vaccine within 30 days prior to the first dose of pembrolizumab
- •Transfusion of blood or administration of colony stimulating factors within 2 weeks of the screening blood sample
- •Active autoimmune disease
- •Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
- •Solid organ or allogeneic bone marrow transplant
- •Pneumonitis or a history of (noninfectious) pneumonitis that required steroids
- •Prior interstitial lung disease
- •Clinically significant heart failure
- •Known history of human immunodeficiency virus (HIV)
- •Known active hepatitis B or C
- •Active infection requiring treatment
研究组 & 干预措施
Pembrolizumab
Participants will receive pembrolizumab (every 21 days) until disease recurrence, unacceptable toxicity, or they undergo up to 18 total cycles (approximately 1 year of treatment), whichever is sooner.
干预措施: Pembrolizumab (Biological)
mRNA-4157 and Pembrolizumab
Participants will receive up to 9 doses of mRNA-4157 (every 21 days). Participants may continue on pembrolizumab (every 21 days) until disease recurrence, unacceptable toxicity, or they undergo up to 18 total cycles (approximately 1 year of treatment), whichever is sooner.
干预措施: mRNA-4157 (Drug)
mRNA-4157 and Pembrolizumab
Participants will receive up to 9 doses of mRNA-4157 (every 21 days). Participants may continue on pembrolizumab (every 21 days) until disease recurrence, unacceptable toxicity, or they undergo up to 18 total cycles (approximately 1 year of treatment), whichever is sooner.
干预措施: Pembrolizumab (Biological)
结局指标
主要结局
Recurrence-Free Survival (RFS), Assessed Using Radiological Imaging
时间窗: Up to 7 years
RFS is defined as the time between the date of first dose of pembrolizumab and the date of recurrence (local, regional, or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.
次要结局
- Distant Metastasis-Free Survival (DMFS), Assessed Using Radiological Imaging(Up to 7 years)
- Number of Participants With Adverse Events (AEs)(Baseline through 100 days after last mRNA-4157 dose or up to 90 days after the last dose of pembrolizumab, whichever is later (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm))
- Number of Participants Who Discontinued Due to AEs(Baseline through 100 days after last mRNA-4157 dose or up to 90 days after the last dose of pembrolizumab, whichever is later (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm))