NL-OMON55643已完成2 期
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 (CNIR178X2201) - CNIR178X2201
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 18
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
- •Males and females >=18 years of age.
- •Histologically documented advanced or metastatic solid tumors or lymphoma.
- •- Part 1: histologically confirmed advanced or metastatic renal cell
- •carcinoma, pancreatic cancer, urothelial cancer, head and neck cancer,
- •non-Hodgkin lymphoma, microsatellite stable or mismatch repair colorectal
- •cancer, triple negative breast cancer or cutaneous melanoma (confirmed BRAF
- •V660E status) or mCRPC
- •- Part 2: histologically confirmed advanced or metastatic NSCLC (EGFR and ALK
- •- Part 3: histologically confirmed advanced or metastatic TNBC
- •Tumor amenable to biopsy. See protocol page 52 for details.
- •Part 1 - 3 only: Patients (other than those with DLBCL) must previously have
- •received at
- •least 1 and no more than 3 prior lines of therapy for their disease.
- •No prior immunotherapy, except for cutaneous melanoma, I/O pre-treated
- •head/neck ca, and TNBC patients enrolled in part 3. An additional tumor type
- •might be added based on data.
- •Measurable disease.
- •ECOG performance status 0, 1, 2.
- •Refer to section Protocol section 5.2 for more detailed information regarding
- •prior therapy per tumor type
排除标准
- •History of another primary malignancy. .
- •Active or prior documented autoimmune disease within the past 2 years.
- •History of interstitial lung disease or non-infectious pneumonitis.
- •Ongoing or prior treatment with A2aR inhibitors. Patients previously treated
- •with A2aR inhibitors for non-oncologic indications may be considered for
- •enrollment on a case by case basis.
- •More than 2 or 3 prior lines of therapy (depending on the tumor type)
- •Clinical laboratory abnormalities (within 21 days before 1st dose): Absolute
- •neutrophil count <1.0 x 109/L - Platelet count <100 x 109/L (for lymphoma <75 x
- •109/L , Hemoglobin (Hgb) <9 g/dL (5,59 mmol/l), Creatinine > 1. x upper limit
- •of normal (ULN) - Total bilirubin >1.5 x ULN - ALT and AST (liver) >3 x ULN
- •History or current cardiac disease indicating significant risk of safety such
- •as uncontrolled cardiac disease (see criterion 29 protocol section 5.3)
- •Mean QTcF >470 ms.
- •Current or prior use of immunosuppressive medication within 28 days before
- •the first dose of PDR001.
- •Smoking must be discontinued at least 7 days prior to initiating study drug
- •administration; smoking cessation products may be used.
- •For more details see protocol section 5.3
研究者
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