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

JRCT ID: jRCT2031200298

Registered date:15/01/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Metastatic Pancreatic Ductal Adenocarcinoma
• Date of first enrollment: 02/03/2021
• Target sample size: 20
• Countries of recruitment: United States,Japan,Germany,Japan,Spain,Japan,South Korea,Japan
• Study type: Interventional

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 Outcome

Safety, Efficacy
Observation/Inspection, RECIST v1.1

Secondary Outcome

Safety, Efficacy
Observation/Inspection, RECIST v1.1

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

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

• Primary Sponsor: Shreya Badhrinarayanan, B.M.B.S.
• Secondary ID(s): NCT03193190