drugset
drugset / Trial / NCT03193190

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

NCT03193190 ↗

Phase 1/2 Completed 341 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-07-05
Primary completion
2025-02-27
Completion
2025-02-27

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 840 mg Intravenous
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Atezolizumab Monoclonal antibody 1680 mg Intravenous
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Subject Cobimetinib Small molecule 60 mg Oral
Subject Etrumadenant Small molecule 150 mg Oral
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Comparator Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Motixafortide Peptide 1.25 mg/kg Subcutaneous
Comparator Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Paclitaxel Small molecule 125 mg/m2 Intravenous
Subject Pegvorhyaluronidase Alfa Protein / enzyme biologic 3 ug/kg Intravenous
Subject Selicrelumab Monoclonal antibody 16 mg Subcutaneous
Subject Tiragolumab Monoclonal antibody 420 mg Intravenous
Subject Tocilizumab Monoclonal antibody 8 mg/kg Intravenous
Comparator fluorouracil Small molecule 400 mg/m2 Intravenous
Comparator fluorouracil Small molecule 2400 mg/m2 Intravenous
Subject simlukafusp alfa Protein / enzyme biologic 10 mg Intravenous
Subject simlukafusp alfa Protein / enzyme biologic 15 mg Intravenous

Indications

pancreatic adenocarcinoma