A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)
Completed · Phase 1/Phase 2
Conditions studied: Pancreatic Adenocarcinoma
In brief
A Phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma (PDAC). Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of patients who have received no prior systemic therapy for metastatic PDAC, and Cohort 2 will consist of patients who have received one line of prior systemic therapy for PDAC. In each cohort, eligible patients will be assigned to one of several treatment arms.
Key facts
- Study ID
- NCT03193190
- Run by
- Hoffmann-La Roche
- People needed
- 341
- Starts
- 2017-07-05
- Expected to finish
- 2025-02-27
- Last updated by the study team
- 2025-11-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma
- For patients in Cohort 1: no prior systemic treatment for PDAC
- For patients in Cohort 2: disease progression during administration of either 5-FU- or gemcitabine-based first-line chemotherapy
- 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
You may not qualify if…
- 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
Where it is running
- City of Hope Comprehensive Cancer Center — Duarte, California, United States
- Helen Diller Fam Comp Can Ctr — San Francisco, California, United States
- Smilow Cancer Hospital at Yale New Haven — New Haven, Connecticut, United States
- Lombardi Cancer Center, Georgetown University — Washington D.C., District of Columbia, United States
- Uni of Chicago Medical Center — Chicago, Illinois, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- MorristownMedicalCenter — Morristown, New Jersey, United States
- Columbia University — New York, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Oregon Health and Science University — Portland, Oregon, United States
- Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- Universitätsklinikum Essen — Essen, Germany
- National Cancer Center Hospital East — Chiba, Japan
- Kanagawa Cancer Center — Kanagawa, Japan
- National Cancer Center Hospital — Tokyo, Japan
- Seoul National University Hospital — Seoul, South Korea
- Asan Medical Center — Seoul, South Korea
- Samsung Medical Center — Seoul, South Korea
- Clínica Universidad de Navarra — Pamplona, Navarre, Spain
- Hospital Universitario Vall d Hebron — Barcelona, Spain
- Hosp. G. U Gregorio Marañón — Madrid, Spain
- Hospital Universitario Ramon y Cajal — Madrid, Spain
Full record on ClinicalTrials.gov
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