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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:July 5, 2017
End Date:September 19, 2020
Contact:Reference Study ID Number: WO39608 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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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)

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.


Inclusion Criteria:

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

- Histologically 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

Exclusion Criteria:

- Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases

- History of leptomeningeal disease

- Active or history of autoimmune disease or immune deficiency

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest computed tomography (CT) scan

- Positive human immunodeficiency (HIV) test at screening or at any time prior to
screening

- Active hepatitis B or C virus infection or active tuberculosis

- Severe infection within 4 weeks prior to initiation of study treatment

- Prior allogeneic stem cell or solid organ transplantation

- History of malignancy other than pancreatic carcinoma within 2 years prior to
screening, with the exception of those with a negligible risk of metastasis or death
We found this trial at
17
sites
1 Augustenburger Platz
Berlin, 13353
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Duarte, CA
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Chicago, IL
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6409 North Quail Hollow Road
Germantown, Tennessee 38138
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Germantown, TN
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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Morristown, New Jersey 07962
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Morristown, NJ
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New Haven, Connecticut 06520
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New Haven, CT
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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Philadelphia, PA
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5115 Centre Avenue
Pittsburgh, Pennsylvania 15232
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1600 Divisadero Street
San Francisco, California 94143
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Washington, District of Columbia 02007
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Washington,
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