NCT03193190

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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 341 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Nab-Paclitaxel	Nab-Paclitaxel will be administered as per the schedule specified in the respective arm.
DRUG	Gemcitabine	Gemcitabine will be administered as per the schedule specified in the respective arm.
DRUG	Oxaliplatin	Oxaliplatin will be administered as per the schedule specified in the respective arm.
DRUG	Leucovorin	Leucovorin will be administered as per the schedule specified in the respective arm.
DRUG	Fluorouracil	Fluorouracil will be administered as per the schedule specified in the respective arm.
DRUG	Atezolizumab	Atezolizumab will be administered as per the schedule specified in the respective arm.
DRUG	Cobimetinib	Cobimetinib will be administered as per the schedule specified in the respective arm.
DRUG	PEGPH20	PEGPH20 will be administered as per the schedule specified in the respective arm.
DRUG	BL-8040	BL-8040 will be administered as per the schedule specified in the respective arm.
DRUG	Selicrelumab	Selicrelumab will be administered as per the schedule specified in the respective arm.
DRUG	Bevacizumab	Bevacizumab will be administered as per the schedule specified in the respective arm.
DRUG	RO6874281	RO6874281 will be administered as per the schedule specified in the respective arm
DRUG	AB928	AB928 will be administered as per the schedule specified in the respective arm.
DRUG	Tiragolumab	Tiragolumab will be administered as per the schedule specified in the respective arm.
DRUG	Tocilizumab	Tocilizumab will be administered as per the schedule specified in the respective arm.

Timeline

• Start date: 2017-07-05
• Primary completion: 2025-02-27
• Completion: 2025-02-27
• First posted: 2017-06-20
• Last updated: 2025-11-21
• Results posted: 2025-11-21

Locations

23 sites across 5 countries: United States, Germany, Japan, South Korea, Spain

Regulatory

• FDA-regulated drug study