NL-OMON53097已完成不适用
A phase I-Ib/II, open-label, multi-center study of the safety and efficacy of MBG453 as single agent and in combination with PDR001 in adult patients with advanced malignancies - CMBG453X2101
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 33
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 64（—）
入选标准
- •* Phase I-Ib part: Advanced/metastatic solid tumors, with (non)-measurable
- •disease, who have progressed despite standard therapy or are intolerant of
- •standard therapy, or for whom no standard therapy exists, and who did not
- •receive prior anti-PD1/PD-L1 treatment. Prior therapy with PD-1/PDL-1
- •inhibitors is allowed provided any toxicity attributed to prior PD-1 or
- •PD-L1-directed therapy did not lead to discontinuation of therapy.
- •* Phase II single agent part: advanced/metastatic solid tumors in the
- •indication in which signs of
- •anti-tumor activity (CR, PR or durable SD with tumor shinkrage that does not
- •qualify for PR) were seen during phase I. Patients must have measurable
- •disease, have progressed despite standard therapy or be intolerant to standard
- •* Phase II part combination therapy: Advanced/metastatic solid tumors, with at
- •least one measurable lesion, who have received standard therapy or are
- •intolerant of standard therapy, have progressed following their last prior
- •therapy, and fit into one of the following groups: non-small cell lung cancer
- •or melanoma pretreated with anti-PD-1/PD-L1 therapy.
- •* ECOG performance status 0-1-2.
- •* Disease amenable to biopsy and a candidate for tumor biopsy according to the
- •treating institution*s guidelines. Patient must be willing to undergo a new
- •tumor biopsy at baseline, and during therapy on this study.
排除标准
- •* Symptomatic CNS metastases or CNS metastases that require local CNS-directed
- •therapy or increasing doses of corticosteroids within the prior 2 weeks.
- •Patients with treated brain metastases should be neurologically stable
- •* Out of range laboratory values.
- •* Impaired cardiac function or clinically significant cardiac disease.
- •* HBV or HCV positive patients, with active disease or whose hepatitis is not
- •controlled by therapy are excluded. HIV positive patients are excluded.
- •* Active autoimmune disease or history of autoimmune disease
- •* Any condition that requires systemic steroids
- •* Systemic anti-cancer therapy within 2-4 weeks of the first dose of study
- •* Vaccines against infectious diseases within 4 weeks of initiation of study
- •* Major surgery within 2 weeks.
- •* Radiotherapy within 2 weeks, except for palliative radiotherapy to a limited
- •* Use of hematopietic growth factors (CSF) within 2 weeks.
- •* Prior participation in an interventional, investigational cancer vaccine or
- •immunotherapy study except for an anti-PD-1/PD-L1 study.
- •* Participation in another type of interventional study in the last 2 weeks.
- •For details refer to protocol page 35-36
研究者
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