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)

F. Hoffman-La Roche Ltd0 个研究点目标入组 185 人开始时间: 2017年6月22日最近更新: 2017年10月2日

试验速览

暂无简介。

•- Age >= 18 years
•- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•- Histologically or cytologically confirmed metastatic PDAC
•- Disease progression during or within 6 months after treatment with one line of 5-fluorouracil or gemcitabine-based chemotherapy in the metastatic setting
•- Life expectancy >=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 Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
•- 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 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
•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 65
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 120

•- 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 scan
•- Positive 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

F. Hoffman-La Roche Ltd