EUCTR2016-000210-29-ES进行中（未招募）1 期
A Phase Ib/II, open label, multicenter study of MCS110 in combination with PDR001 in patients with advanced malignancies
ovartis Farmacéutica, S.A.0 个研究点目标入组 141 人开始时间: 2016年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 141
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age >/= 18 years.
- •- Phase Ib part: Patients with advanced melanoma, endometrial carcinoma, pancreatic or triple negative breast cancer, with measurable or non-measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
- •- Phase II part: Patients with advanced solid tumors with at least one measurable lesion as determined by RECIST version 1.1, who have received standard therapy or are intolerant of standard therapy, who have progressed following their last prior therapy, and fit into one of the following groups:
- •- Group 1: TNBC who did not receive prior anti-PD-1/PD-L1 treatment
- •- Group 2 : Pancreatic adenocarcinoma who did not receive prior anti-PD-1/PD-L1 treatment
- •- Group 3 : Endometrial carcinoma who did not receive prior anti-PD-1/PD-L1 treatment
- •- Group 4: Melanoma who progressed on prior PD-1- and PD-L1-directed therapies.
- •- ECOG Performance Status - Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution´s guidelines. Patient must be willing to undergo a new tumor biopsy at screening, and during therapy on this study. Exceptions for patients with sites of disease not amenable to biopsy may be considered after discussion with the sponsor.
- •Other inclusion criteria as per protocol may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •-Presence of symptomatic CNS metastases, or CNS metastases thatrequire local CNS-directed therapy
- •-History of severe hypersensitivity reactions to other mAbs
- •-Impaired cardiac function or clinically significant cardiac disease
- •-Active autoimmune disease or a documented history of autoimmune disease within three years before screening
- •-Active infection requiring systemic antibiotic therapy
- •-Known history of HIV infection
- •-Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, or requiring antiviral treatment
- •Other exclusion criteria as per protocol may apply.
研究者
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