NCT05652673招募中不适用
Safe Stop IPI-NIVO Trial: Early Discontinuation of Nivolumab Upon Achieving a (confirmed) Complete or Partial Response in Patients with Irresectable Stage III or Metastatic Melanoma Treated with First-line Ipilimumab-nivolumab
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Ongoing response
研究概览
简要总结
Safe Stop IPI-NIVO Trial: Early discontinuation of nivolumab upon achieving a (confirmed) complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 of age or older
- •Irresectable stage III or metastatic melanoma
- •Treated with at least one dose of first-line ipilimumab-nivolumab and considered to be a candidate for maintenance treatment with nivolumab:
- •previous systemic treatment, including immune-checkpoint inhibitors, in (neo)adjuvant setting for resectable melanoma is allowed
- •in this protocol, nivolumab maintenance is interchangeable with pembrolizumab maintenance therapy.
- •Response evaluation according to RECIST v1.1 30 using a diagnostic CT documenting target lesions every 12 (-2/+6) weeks from the start of ipilimumab-nivolumab:
- •for patients with CR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET/CT) is allowed at baseline
- •for patients with PR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET/CT) is allowed if sufficient target lesions are measurable for response evaluation according to RECIST v1.1 criteria 30
- •in case of asymptomatic brain metastases prior to start of first-line ipilimumab-nivolumab, intracerebral tumor response should be confirmed using an MRI for response evaluation prior to inclusion in this study.
- •Patients should be included after first CR/PR or first confirmed CR/PR according to RECIST v1.1 30:
- •inclusion should take place no later than 5 weeks after first confirmed CR/PR
- •in case of SD at first response evaluation, confirmed CR/PR is required for inclusion
- •planned and willing to discontinue nivolumab within 4(+1) weeks after inclusion, i.e. first CR/PR or first confirmed CR/PR
- •no later than 9 months after start of treatment with ipilimumab-nivolumab
- •Presence of MRI brain for the screening of brain metastases (prior to discontinuation of ipilimumab-nivolumab)
- •Participants with previously locally treated brain metastases may participate in case they meet the following criteria:
- •completely asymptomatic brain metastases at inclusion
- •MRI of brain at baseline and for response evaluation during treatment
- •Signed and dated informed consent form
排除标准
- •Patients with SD/PD according to RECIST v1.1
- •Malignant disease other than being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to start of study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ.
- •Presence of symptomatic brain metastases:
- •prior to first-line treatment with ipilimumab-nivolumab, or;
- •when defined as new or progressive brain metastases at the time of study entry;
- •brain metastases with need for steroid treatment in the last 8 weeks prior to study entry Note: An incidental epileptic seizure caused by a brain lesion is not considered an exclusion criterion.
- •(provided that the other in- and exclusion criteria are met);
- •Presence of leptomeningeal metastases;
- •Systemic chronic steroid therapy (>10mg/day prednisone or equivalent) at inclusion or patients who need or needed any other second-line immunosuppressive therapy (e.g. infliximab, mycophenolate mofetil) for the treatment of immune related adverse events (irAEs). Note: local steroids such as topical, inhaled, nasal and ophthalmic steroids are allowed.
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
研究组 & 干预措施
Early discontinuation of nivolumab
Experimental
干预措施: nivolumab (Drug)
结局指标
主要结局
Ongoing response
时间窗: 12 months after start of ipilimumab-nivolumab combination therapy
The rate of ongoing response at 12 months in patients with irresectable stage III or metastatic melanoma who are treated with first-line ipilimumab-nivolumab and who early discontinue nivolumab upon achieving a CR or PR according to RECIST v1.1
次要结局
- ORR(5 years after inclusion)
- Re-treatment(5 years after inclusion)
- Ongoing response(24 months after start of treatment)
- Disease control(5 years after inclusion)
- duration of response(5 years after inclusion)
- Melanoma Specific Survival rate(5 years after inclusion)
- Overall Survival(5 years after inclusion)
- (serious) adverse events(5 years after inclusion)
- Disease control (CR/PR/SD [stable disease]/not PD [progressive disease]) after restarting (systemic) treatment for melanoma(5 years after inclusion)
- Quality of life questionnaires EuroQoL EQ-5D-5(5 years after inclusion)
研究者
A.A.M. van der Veldt
Doctor
Erasmus Medical Center
研究点 (1)
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