NCT03383458进行中（未招募）3 期
A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 545
- 试验地点
- 350
- 主要终点
- Recurrence-free Survival (RFS)
研究概览
简要总结
This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Participants with a first diagnosis of HCC who have undergone a curative resection or ablation
- •Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC
- •Child-Pugh Score 5 or 6
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- •Any evidence of tumor metastasis or co-existing malignant disease
- •Participants previously receiving any prior therapy for HCC, including loco-regional therapies
- •Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation
- •Participants who have received a live/attenuated vaccine within 30 days of randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella [MMR]).
- •Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm B
Placebo Comparator
干预措施: Placebo (Other)
Arm A
Experimental
干预措施: Nivolumab (Biological)
结局指标
主要结局
Recurrence-free Survival (RFS)
时间窗: Up to 49 months
次要结局
- Time to recurrence (TTR)(Up to 49 months)
- Overall Survival (OS)(Up to 7 years)
研究者
研究点 (350)
Loading locations...
相似试验
已完成
3 期
Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV MelanomaMelanomaNCT02388906Bristol-Myers Squibb906
终止
3 期
A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV MelanomaMelanomaNCT05002569Bristol-Myers Squibb1,093
已完成
3 期
A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a KidneyCarcinoma, Renal CellNCT03138512Bristol-Myers Squibb1,641
进行中（未招募）
3 期
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C MelanomaMelanomaNCT04099251Bristol-Myers Squibb790
已完成
3 期
A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder CancerMuscle-Invasive Bladder CancerBladder TumorBladder CancerNCT04209114Bristol-Myers Squibb114