A Phase Ib/II, Open-label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-based Treatment Combinations in Patients with Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)

Shreya Badhrinarayanan, B.M.B.S.0 个研究点目标入组 20 人开始时间: 2021年1月15日最近更新: 2023年11月20日

研究概览

暂无简介。

•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma
•- no prior systemic treatment for PDAC
•- Life expectancy greater than or equal to 3 months
•- Availability of a representative tumor specimen that is suitable for determination of programmed death-ligand 1 (PD-L1) and/or additional biomarker status via central testing
•- Measurable disease (at least one target lesion) according to RECIST v1.1
•- Adequate hematologic and end-organ function test results
•- Tumor accessible for biopsy
•- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs, as outlined for each specific treatment arm
•- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm

•- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage procedure (i.e., more than one time per month)
•- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
•- History of leptomeningeal disease
•- Active or history of autoimmune disease or immune deficiency
•- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
•- Positive human immunodeficiency (HIV) test at screening or at any time prior to screening
•- Active hepatitis B or C virus infection or active tuberculosis
•- Severe infection within 4 weeks prior to initiation of study treatment
•- Prior allogeneic stem cell or solid organ transplantation
•- History of malignancy other than pancreatic carcinoma within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death

发起方

Shreya Badhrinarayanan, B.M.B.S.