A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants 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.

Conditions

• Pancreatic Adenocarcinoma

Interventions

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.

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.

Sponsors & Collaborators

• Hoffmann-La Roche

  lead INDUSTRY

Principal Investigators

• Clinical Trials · Hoffmann-La Roche

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-05

Primary Completion

2025-02-27

Completion

2025-02-27

FDA Drug

Yes

Countries

• United States
• Germany
• Japan
• South Korea
• Spain

Study Locations