Study of Adjuvant Durvalumab (MEDI4736) Plus Regorafenib vs Untreated Control in Stage IV Colorectal Cancer Patients With no Evidence of Disease (NED): VIVA Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Disease Free Survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Durvalumab plus Regorafenib versus observation for patients with stage IV colorectal cancer achieving the no evidence of disease state.
The NED state can be achieved in any line of treatment and it is defined as:
- R0 resection for surgery,
- the complete ablation defect covering the lesion on CT scan for radiofrequency,
- the erogation of ≥ 60 Gy for stereotactic radiotherapy,
- complete response to antineoplastic treatments on CT scan. In all these cases CEA and CA 19.9 must be within normal limits at the time of randomization.
Participants in this study will receive:
Experimental arm:
Regorafenib 90 mg d1-21 every 28 days plus Durvalumab 1500 mg every 28 days for 1 year
Control arm:
Observation (crossover to Experimental arm is allowed in case of relapse)
Tumor assessment will be performed every 12 weeks.
详细描述
The safety run-in phase is planned for the first 4 patients randomized to the experimental arm using a starting dose of 60 mg/die of Regorafenib (and fixed 1500 mg of Durvalumab), to be escalated after 2 months to 90 mg/die if < 2 patients report serious adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •≥ 18 years; ECOG PS 0-1;
- •Body weight >30 kg;
- •Histologically confirmed diagnosis of colorectal adenocarcinoma;
- •Patients must be in NED after completion of any treatments for stage IV CRC, including resections, RFA; RT with or without neoadjuvant/adjuvant therapies or CR after chemotherapy;
- •Patients must be randomized within 10 weeks since the achievement of the NED state. Those who have also received adjuvant therapy following the locoregional treatment are still eligible, provided they are randomized within 4 weeks since the last chemotherapy cycle;
- •NED state ascertained by means of CT scan and/or PET scan and/or MRI scan;
- •Life expectancy of at least 12 weeks;
- •CEA within normal limits;
- •No residual toxicity from previous chemotherapy;
- •Adequate organ function;
- •Exclusion criteria:
- •MSI/dMMR patients;
- •Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia and vitiligo;
- •Active or prior documented autoimmune or inflammatory disorders;
- •Relevant concomitant comorbidities;
排除标准
- 未提供
研究组 & 干预措施
DURVALUMAB + REGORAFENIB
Durvalumab 1500 mg (120-minute IV infusion) every 28 days, Regorafenib 90 mg/die orally once daily for 21 days in a 28-day cycle.
Treatment will be administred up to 1 year.
干预措施: Durvalumab Injection for intravenous use 500 mg vial solution for infusion (Drug)
DURVALUMAB + REGORAFENIB
Durvalumab 1500 mg (120-minute IV infusion) every 28 days, Regorafenib 90 mg/die orally once daily for 21 days in a 28-day cycle.
Treatment will be administred up to 1 year.
干预措施: Regorafenib 30 mg capsules (Drug)
结局指标
主要结局
Disease Free Survival
时间窗: approximately 48 months
Disease free survival, defined as the time from the date of randomization to the earliest documented disease relapse (local or distant), death due to any cause or two consecutive increases of CEA above upper limit (time gap no longer than 30 days).
次要结局
- Overall Survival(approximately 48 months)
- 18 months - Disease Free Survival(approximately 48 months)
- Incidence of adverse events(approximately 48 months)