Surgery of Melanoma Metastases After Systemic Therapy - the SUMMIST Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- DFS 12 months
研究概览
简要总结
To evaluate if surgical removal of residual disease adds benefit in stage IV melanoma patients with partial response or stable disease after a minimum 9 months of first-line PD-1 inhibition. Primary endpoint: Disease-free survival (DFS) at 12 months.
详细描述
A Phase II Randomized Controlled Open-Label Parallel Group Interventional Multicenter Trial. Patients with metastatic melanoma, stratified for stage M1a or M1b/M1c, that have received first-line treatment with PD-1 inhibitors for a minimum of 9 months resulting in either partial response or stable disease according to RECIST 1.1 will be eligible. Patients will be screened for operability based on CT-scans examined by a multidisciplinary team, with the criteria that complete (R0) resection of all metastases should be possible. If the multidisciplinary team find that this would be possible, patients will be included and randomized 1:1 to either surgery with continued PD1-inhibition or current standard of care with continued PD1-inhibition only. At progression, treatment will be according to the treating medical oncologist. Active follow-up will be performed for 12 months.
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
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
- •Age above 18 years
- •Signed and dated written informed consent before the start of specific protocol procedures
- •Biopsy or cytology proven metastatic melanoma stage M1a, M1b or M1c
- •Have received a minimum of 9 months of immunotherapy (PD1-inhibitor alone or in combination) resulting in stable disease or partial response according to RECIST 1.1
- •Metastases judged to be radically resectable by surgery at a multidisciplinary conference
- •ECOG performance status 0-2
排除标准
- •Brain metastasis (M1d)
- •Previous treatment with BRAF/MEK inhibitors
- •Inability to understand given information or undergo study procedures according to protocol
研究组 & 干预措施
PD1-inhibitor + surgery
Patients randomised to the interventional study arm, receiving both surgical metastasectomy and continued immunotherapy. Each patient case will be individually planned for surgery. Procedures will include, but will not be limited to, lung resections, liver resections, bowel resection, skin excisions and lymph node clearances. Patients in both study arms will continue with PD-1 inhibitor 12 months after randomization, and will then be treated according to their medical oncologist.
干预措施: Surgical metastasectomy (Procedure)
PD1-inhibitor
Patients randomized to control study arm, receiving continued immunotherapy only. Patients in both study arms will continue with PD-1 inhibitor 12 months after randomization, and will then be treated according to their medical oncologist.
干预措施: Immunotherapy (Drug)
结局指标
主要结局
DFS 12 months
时间窗: 12 months
Disease free survival
次要结局
- Complications(3 months post operatively)
- OS 12 months(12 months)
- SAE 12 months(12 months)
- R0 resection(3 months post operatively)
- MSS 12 months(12 months)
- PFS 12 months(12 months)
研究者
Roger Olofsson Bagge
Associate professor, Senior Consultant Surgeon
Sahlgrenska University Hospital, Sweden