A Phase 2, multi-center, open label study of NIR178 in combination with PDR001 in patients with selected advanced solid tumors and non-Hodgkin lymphoma

ovartis Pharma AG0 个研究点目标入组 300 人开始时间: 2017年12月14日最近更新: 2018年1月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: ovartis Pharma AG
入组人数: 300

研究概览入排标准研究者记录与标识符相似试验

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

•- Histologically documented advanced or metastatic solid tumors or lymphomas
•. Part 1: histologically confirmed renal cell carcinoma (RCC), pancreatic cancer, urothelial cancer, head and neck cancer, diffuse large B-cell lymphoma (DLBCL), microsatellite stable (MSS) colon cancer, triple negative breast cancer (TNBC) or melanoma
•. Part 2: histologically confirmed diagnosis of advanced/metastatic NSCLC. For those with mixed histology, there must be a predominant histology
•. Part 3: histologically confirmed diagnosis of advanced/metastatic NSCLC and one additional tumor type based on emerging data from part 1 of the study.
•- 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 again during therapy on this study. The collection of recent sample is permitted under the following conditions (both must be met):
•. Biopsy was collected = 3 months before 1st dose of study treatment and available at the site.
•. No immunotherapy was given to the patient since collection of biopsy.
•- Patients must previously have received at least 1 and no more than 3 prior lines of therapy for their disease
•- Patients must not have received prior immunotherapy (previous immune checkpoint inhibitors; single agent and/or combination therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1), except for NSCLC patients enrolled in part 3
•- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral computer tomography (CT) scan, Magnetic Resonance Imaging (MRI), or calipers by clinical exam.
•Other protocol defined inclusion criteria 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 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 180

排除标准

•- Ongoing or prior treatment with A2aR inhibitors. Patients previously treated with A2aR inhibitors for non-oncologic indications (e.g. Parkinson’s disease) may be considered for enrollment on a case by case basis.
•- Current or prior use of immunosuppressive medication within 28 days before the first dose of PDR001, with the exception of intranasal/inhaled corticosteroids or systemic corticosteroids at physiological doses (not exceeding equivalent of 10 mg/day of prednisone)
•- History of interstitial lung disease or non-infectious pneumonitis
•- History of another primary malignancy except for:
•. Malignancy treated with curative intent and with no known active disease =2 years before the first dose of study drug and of low potential risk for recurrence
•. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
•. Adequately treated carcinoma in situ without evidence of disease
•- Active or prior documented autoimmune disease within the past 2 years. Patients with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
•- More than 3 prior lines of therapy
•- Participation in another clinical study with an investigational product during the last 21 days prior to starting on treatment.
•Other protocol defined exclusion criteria may apply.

研究者

发起方

ovartis Pharma AG

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