NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031200298

Registered date:15/01/2021

A Study of Multiple Immunotherapy-based Treatment Combinations in Participants with Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedMetastatic Pancreatic Ductal Adenocarcinoma
Date of first enrollment02/03/2021
Target sample size20
Countries of recruitmentUnited States,Japan,Germany,Japan,Spain,Japan,South Korea,Japan
Study typeInterventional
Intervention(s)Experimental/Tiragolumab arm: Atezolizumab 840 mg and Tiragolumab 420 mg IV infusion on days 1 and 15 of each 28 day cycle. Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 IV infusion on days 1, 8, and 15 of each 28 day cycle. Experimental/Tocilizumab arm: Tocilizumab 8 mg/kg IV infusion on day 1 of each 28 day cycle. Atezolizumab 1680 mg IV infusion on day 1 of each 28 day cycle. Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 IV infusion on days 1, 8, and 15 of each 28 day cycle. Control arm: Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 IV infusion on days 1, 8, and 15 of each 28 day cycle.

Outcome(s)

Primary OutcomeSafety, Efficacy Observation/Inspection, RECIST v1.1
Secondary OutcomeSafety, Efficacy Observation/Inspection, RECIST v1.1

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria- 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
Exclude criteria- 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

Related Information

Contact

Public contact
Name Clinical trials information
Address 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo Tokyo Japan 103-8324
Telephone +81-120-189-706
E-mail clinical-trials@chugai-pharm.co.jp
Affiliation Chugai Pharmaceutical Co., Ltd.
Scientific contact
Name Shreya Badhrinarayanan, B.M.B.S.
Address 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo Tokyo Japan 103-8324
Telephone +81-120-189-706
E-mail clinical-trials@chugai-pharm.co.jp
Affiliation F. Hoffmann-La Roche Ltd