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)

  • End date
    Jun 1, 2024
  • participants needed
  • sponsor
    Hoffmann-La Roche
Updated on 24 October 2022
systemic therapy
measurable disease
ductal adenocarcinoma
pancreatic ductal adenocarcinoma


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.

Condition Pancreatic Adenocarcinoma
Treatment fluorouracil, Gemcitabine, bevacizumab, Oxaliplatin, Tocilizumab, Nab-paclitaxel, Leucovorin, Cobimetinib, Atezolizumab, Emactuzumab, BL-8040, RO6874281, PEGPH20, Selicrelumab, AB928, Tiragolumab
Clinical Study IdentifierNCT03193190
SponsorHoffmann-La Roche
Last Modified on24 October 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion 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
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