IRB #

STUDY00017094

Title

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combination in Patients with Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)

Principal Investigator

Charles Lopez

Study Purpose

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in patients with metastatic pancreatic ductal adenocarcinoma (PDAC).

The experimental arms include: Atezo + BL8040, Atezo + Cobimetinib, Atezo + PEGPH20

The control arm is Gemcitabine + Nab-paclitaxel or mFOLFOX6 depending on the type of chemo previously received

Medical Condition(s)

Metastatic pancreatic ductal adenocarcinoma

Eligibility Criteria

Inclusion:
Age ≥ 18 years

Histologically or cytologically confirmed metastatic PDAC

Disease progression during or within 6 months after treatment with one line of 5-fluorouracil (5-FU)− or gemcitabine-based chemotherapy in the metastatic setting

Life expectancy ≥ 3 months, as determined by the investigator

Exclusion:
Prior treatment with anti−CTLA-4, anti−PD-1, and anti−PD-L1 therapeutic antibodies

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Until disease progression and survival follow-up

Minors Included

No

Contact

OHSU Knight Cancer Institute Information line 503-494-1080
trials@ohsu.edu

Sponsor

F. Hoffmann-La Roche Ltd

Recruitment End

12/31/2030

Compensation Provided

No


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