NL-OMON55892
招募中
2 期
Combination of targeted therapy (encorafenib and binimetinib) followed by combination of immunotherapy (ipilimumab and nivolumab) vs immediate combination of immunotherapy in patients with unresectable or metastatic melanoma with BRAF V600 mutation : an EORTC randomized phase II study (EBIN) - EORTC 1612 (EBIN) study
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 4 人开始时间: 待定最近更新:
概览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- European Organisation for Research in Treatment of Cancer (EORTC)
- 入组人数
- 4
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
- •Histologically or cytologically confirmed unresectable stage III/ IV
- •cutaneous or mucosal melanoma • Presence of BRAF V600E or V600K mutation in
- •tumor tissue prior to enrolment as per local assessment • Tumor tissue from an
- •unresectable or metastatic site of disease must be provided for biomarker
- •analyses. This can be an archived sample if obtained at maximum 3 months prior
- •to randomization and if the patient did not receive treatment since then. •
- •Measurable disease per RECIST 1\.1 criteria by computed tomography (CT) or
- •magnetic resonance imaging (MRI) of Chest/Abdomen/Pelvis and brain CT/MRI
- •performed within 28 days prior to randomization • Patients \>\= 18 years of age •
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 •
排除标准
- •Uveal melanoma • Any symptomatic brain or leptomeningeal disease. Subjects
- •with brain metastases are eligible if these have been locally treated and there
- •is no magnetic resonance imaging (MRI) evidence of progression 4 weeks after
- •end of treatment. There must also be no requirement for immunosuppressive doses
- •of systemic corticosteroids (\> 10 mg/day prednisone equivalents) for at least 2
- •weeks prior to study drug administration. • Any prior treatment for advanced
- •disease including treatment with an anti\-programmed death receptor\-1 (PD\-1\),
- •anti\-programmed death\-1 ligand\-1 (PD\-L1\), anti\-PD\-L2, anti\-cytotoxic T
- •lymphocyte associated antigen\-4 (anti\-CTLA\-4\) antibody, anti\-LAG\-3, anti\-TIM\-3,
- •anti\-IDO, etc or BRAF or MEK inhibitors. • History of hypersensitivity to study
研究者
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