A phase II, open label, randomized, parallel arm study of NIS793 (with and without spartalizumab) in combination with SOC chemotherapy gemcitabine/nab-paclitaxel, and gemcitabine/nab-paclitaxel alone in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC)

ovartis Pharma AG0 个研究点目标入组 156 人开始时间: 2020年8月12日最近更新: 2024年7月8日

研究概览

暂无简介。

•Participants with histologically or cytologically confirmed treatment naïve metastatic adenocarcinoma of the pancreas with measurable disease per RECIST 1.1.
•Participants must have a site of disease amenable to biopsy, be candidate for tumor biopsy, and must be willing to undergo a tumor biopsy at screening and during therapy on the study.
•ECOG performance status = 1
•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 62
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 94

•Previous radiotherapy, surgery (note: placement of biliary stent is allowed), chemotherapy or investigational therapy for the treatment of metastatic disease. Participants having received previous chemotherapy in the adjuvant setting
•Participants with MSI-H pancreatic adenocarcinoma
•Participants with a diagnosis of pancreatic neuroendocrine tumors (NETs), acinar, or islet cell tumors
•Participants amenable to potentially curative resection
•Presence of symptomatic CNS metastases or CNS metastases that require local CNS-directed therapy
•History of severe hypersensitivity reactions to other monoclonal antibodies
•Malignant disease other than that being treated in the study
•Systemic chronic steroid therapy (>10mg/day prednisone or equivalent) or any immunosuppressive therapy
•Known history of testing positive for HIV infection
•Active HBV and HCV infection
•Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment
•Active, known or suspected autoimmune disease
•History of or current pneumonitis or interstitial lung disease

发起方