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NCT03193190CompletedPhase 1/2

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

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)

Source: ClinicalTrials.gov · Last updated 21 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
341 (actual)
First submitted
9 Jun 2017
Start date
5 Jul 2017
Primary completion date
27 Feb 2025
Lead sponsor
Hoffmann-La Roche
NCT number
NCT03193190
EU CT number
2024-511271-15-00
EudraCT number
2016-004126-42

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 341
  • From 5 Jul 2017 to the primary completion date, 27 Feb 2025
  • 22 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Positive human immunodeficiency (HIV) test at screening or at any time prior to screening
  • Severe infection within 4 weeks prior to initiation of study treatment
  • Prior allogeneic stem cell or solid organ transplantation

Other illness

  • 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
  • Active hepatitis B or C virus infection or active tuberculosis
  • 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

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitätsklinikum Essen
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EssenGermanyUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Clínica Universidad de navarra
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PamplonaSpainCompleted
National Cancer Center Hospital East
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ChibaJapanUnknown status
Kanagawa Cancer Center
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KanagawaJapanUnknown status
National Cancer Center Hospital
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TokyoJapanUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Uni of Chicago Medical Center
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ChicagoUnited StatesUnknown status
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
MorristownMedicalCenter
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MorristownUnited StatesUnknown status
Smilow Cancer Hospital at Yale - New Haven
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New HavenUnited StatesUnknown status
Columbia University
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New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Hillman Cancer Center
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PittsburghUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
Helen Diller Fam Comp Can Ctr
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San FranciscoUnited StatesUnknown status
Lombardi Cancer Center, Georgetown University
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Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.