NL-OMON53859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 - Safe Stop ipi-nivo
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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.
- •o Previous systemic treatment, including ICIs, in (neo)adjuvant setting for
- •resectable melanoma is allowed
- •o In this protocol, nivolumab maintenance is interchangeable with pembrolizumab
- •maintenance therapy.
- •- Response evaluation according to RECIST v1.1 using a diagnostic CT
- •documenting target lesions every 12 (-2/+6) weeks from the start of
- •ipilimumab-nivolumab;
- •o 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
- •o 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.
- •o In case of asymptomatic brain metastases prior to start of first-line
- •ipilimumab-nivolumab, intracerebral tumor response should be confirmed using an
- •MRI prior to inclusion
- •- Patients should be included after first CR/PR or first confirmed CR/PR
- •according to RECIST v1.1
- •o Inclusion should take place no later than 5 weeks after first confirmed CR/PR
- •o In case of SD at first response evaluation, confirmed CR/PR is required for
- •o eligible and willing to discontinue nivolumab within 4(+1) weeks after
- •inclusion, i.e. first CR/PR or first confirmed CR/PR
- •o 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:
- •o completely asymptomatic brain metastases at inclusion
- •o 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
- •* 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 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. This comprises each and every condition or
- •circumstance preventing the patient from showing up to the outpatient controls
- •and/or undergoing the CT-scans, or preventing the patient from (adequately)
- •filling out the questionnaires
研究者
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