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

Trial number:
NCT03193190
Trial phase:
1, 2
Study type:
Immunotherapy
Overall status:
Recruiting

Study start date

July, 2017

Scientific title

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)

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.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Histologically 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

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: None (Open Label),

Conditions

Pancreatic Adenocarcinoma

Other study ID numbers

WO39608; 2016-004126-42

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