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)

STATUS

Recruiting
End date

Jun 1, 2024
participants needed

290
sponsor

Hoffmann-La Roche

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Updated on 24 October 2022

See if I qualify

paclitaxel

cancer

combinations

systemic therapy

measurable disease

fluorouracil

oxaliplatin

gemcitabine

leucovorin

bevacizumab

pdac

ductal adenocarcinoma

pancreatic ductal adenocarcinoma

Summary

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.

Details

Condition	Pancreatic Adenocarcinoma
Treatment	fluorouracil, Gemcitabine, bevacizumab, Oxaliplatin, Tocilizumab, Nab-paclitaxel, Leucovorin, Cobimetinib, Atezolizumab, Emactuzumab, BL-8040, RO6874281, PEGPH20, Selicrelumab, AB928, Tiragolumab
Clinical Study Identifier	NCT03193190
Sponsor	Hoffmann-La Roche
Last Modified on	24 October 2022

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Eligibility		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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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)