Phase
Condition
Digestive System Neoplasms
Treatment
Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX
Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Understand and sign informed consent; be willing to comply with study procedures,including surgery
Age ≥ 18 years
Be a male, or non-pregnant and non-lactating female
Negative serum B-hCG pregnancy test at screening for women of childbearing potential
Male participants with partners of childbearing potential and female participants ofchildbearing potential are required to use highly effective contraception methodsduring the conduct of the study and for 6 months after the last dose of study drug
Histologically or cytologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
Locally advanced pancreatic cancer considered unresectable according to NCCNGuidelines® Version 2.2018 as determined by central imaging
Measurable disease as defined by RECIST 1.1 criteria as determined by centralimaging
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate liver function: aspartate aminotransferase (AST) and alanineaminotransferase (ALT) <2.5 x upper limit of normal (ULN), alkaline phosphatase <2.5x ULN, and bilirubin ≤1.5 x ULN or in participants with biliary stenting ≤2.0 x ULN
Adequate bone marrow function: platelets >100,000 cells/mm3, hemoglobin >9.0 g/dland absolute neutrophil count (ANC) >1,500 cells/mm3
Adequate renal function: creatinine < 1.5 x ULN, creatinine clearance ≥ 30 mL/min
Less than grade 2 pre-existing peripheral neuropathy (per CTCAE)
Exclusion
Exclusion Criteria:
Prior chemotherapy or radiation for pancreatic cancer
Previous (within the past 3 years) or concurrent malignancy diagnosis exceptnon-melanoma skin cancer and in situ carcinomas (excluding in situ breast cancer)
Major surgery within 4 weeks prior to signing informed consent form. Biliary stentsare permitted.
History of allergy or hypersensitivity to human, humanized or chimeric monoclonalantibodies
History of allergy or hypersensitivity to any of the chemotherapy agents beingprescribed or their excipients
Any medical or surgical condition that may place the participant at increased riskwhile on study
Any condition potentially decreasing compliance to study procedures
Exposure to another investigational drug within 28 days of first dosing visit, or 5half-lives of the investigational drug (whichever is longer)
Uncontrolled intercurrent illness including, but not limited to, ongoing or activesystemic infections, symptomatic congestive heart failure, unstable angina pectoris,clinically significant cardiac arrhythmia, or psychiatric illness/social situationsthat would limit compliance with study requirements
Documented history of drug or alcohol abuse within 6 months of signing informedconsent
Any medical condition that, in the opinion of the investigator, may pose a safetyrisk to a participant in this trial, may confound the assessment of safety andefficacy, or may interfere with study participation
Participants with a history of interstitial pulmonary disease, hepatitis C virus (HCV), hepatitis B virus (HBV) or human immunodeficiency virus (HIV) infection
Participants who have been administered a live vaccine within 4 weeks prior to thefirst administration of therapy
Participants who cannot stop chronic medications that inhibit or induce cytochrome P (CYP) 2C8 or CYP3A4
Participants with poorly controlled comorbid conditions, including; congestive heartfailure (CHF), chronic obstructive pulmonary disease (COPD), uncontrolled diabetesmellitus (DM) or neurologic disorders (not acutely related to pancreatic cancer) orlimited function
Study Design
Study Description
Connect with a study center
Klinikum Wels-Grieskirchen GmbH
Wels, 4600
AustriaSite Not Available
Medizinische Universität Wien
Wien, 1090
AustriaSite Not Available
CUB Hôpital Erasme
Brussels, 1070
BelgiumSite Not Available
Universitair Ziekenhuis Gent
Gent, 9000
BelgiumSite Not Available
The Ottawa Hospital
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Princess Margaret Cancer Centre/University Health Network
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
CanadaSite Not Available
McGill University Health Center
Montreal, Quebec H4A 3J1
CanadaSite Not Available
Peking Union Medical College Hospital
Dongcheng, Beijing 100010
ChinaSite Not Available
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
ChinaSite Not Available
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, Shaanxi
ChinaSite Not Available
Huashan Hospital affiliated with Fudan University
Jing'an, Shanghai 200040
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu,
ChinaSite Not Available
Jiangsu Province Hospital
Nanjing,
ChinaSite Not Available
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai,
ChinaSite Not Available
Xinhua Hospital Affiliated to Shanghai Jiaotong University School Of Medicine
Shanghai,
ChinaSite Not Available
CHRU Jean Minjoz
Besançon Cedex, 25030
FranceSite Not Available
CHU Estaing
Clermont Ferrand, 63003
FranceSite Not Available
Hopital BEAUJON
Clichy, 92118
FranceSite Not Available
Centre Georges-François Leclerc
Dijon, 21079
FranceSite Not Available
CHU Grenoble Alpes
La Tronche, 38700
FranceSite Not Available
Centre Léon Bérard
Lyon, 69373
FranceSite Not Available
Hôpital Edouard Herriot
Lyon, 69437
FranceSite Not Available
Groupe Hospitalier Pitié Salpêtrière
Paris, 750013
FranceSite Not Available
Haut-Lévêque
Pessac, 33604
FranceSite Not Available
Institut de Cancérologie de l'Ouest Pays de Loire
Saint Herblain Cedex, 44805
FranceSite Not Available
Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie
Berlin, 10117
GermanySite Not Available
Technische Universität Dresden, Medizinische Klinik und Poliklinik I
Dresden, 01307
GermanySite Not Available
Klinikum der Universität München, Medizinische Klinik und Poliklinik III
München, 81377
GermanySite Not Available
Klinikum rechts der Isar der Technischen Universität München
München, 81675
GermanySite Not Available
Shamir Medical center Asaf Harofeh
Be'er Ya'akov, 7030000
IsraelSite Not Available
Shamir Medical center Asaf Harofeh
Be'er Ya'aqov, 7030000
IsraelSite Not Available
Hadassah University Hospital Ein Kerem
Jerusalem, 9112001
IsraelSite Not Available
Meir Medical center
Kfar Saba, 4428164
IsraelSite Not Available
Rabin Medical Center
Petach Tikva, 4941492
IsraelSite Not Available
Instituto Scientifico Romagnolog per lo Studio e la Cura dei Tumori
Meldola, 47014
ItalySite Not Available
Grande Ospedale Metropolitano Niguarda, Oncologia Medica Falck
Milano, 20162
ItalySite Not Available
IRCCS Ospedale San Raffaele
Milano, 20132
ItalySite Not Available
Istituto Europeo di Oncologia
Milano, 20141
ItalySite Not Available
AOU Federico II
Napoli, 80131
ItalySite Not Available
Istituto Clinico Humanitas
Rozzano, 20089
ItalySite Not Available
CRC di Verona
Verona, 37134
ItalySite Not Available
Seoul National University Budang Hospital
Seongnam-si, Geyonggi-do 13620
Korea, Republic ofSite Not Available
National Cancer Center
Goyang-si, Gyeonggi-do 10408
Korea, Republic ofSite Not Available
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do 58128
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic ofSite Not Available
Alvaro Cunqueiro Hospital
Vigo, Pontevedra 36312
SpainSite Not Available
Hospital Universitaro Vall D'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital de la Santa Creu i Sant Pau
Barcelona, 8041
SpainSite Not Available
Institut Catalá d'Oncologia (ICO Girona). Hospital Dr. Josep Trueta
Girona, 17007
SpainSite Not Available
Hospital Clinico San Carlos
Madrid, 28040
SpainSite Not Available
Hospital General Universitario Gregorio Marañon
Madrid, 28007
SpainSite Not Available
MD Anderson Cancer Center
Madrid, 28033
SpainSite Not Available
Hospital Clinico Universitario de Valencia
Valencia, 46010
SpainSite Not Available
Hospital Universitario Miguel Servet
Zaragoza, 50009
SpainSite Not Available
Imperial College Healthcare NHS Trust
London, W2 1NY
United KingdomSite Not Available
University College London Hospitals NHS Foundation Trust
London, NW1 2PG
United KingdomSite Not Available
St. Joseph's Hospital and Medical Cancer Center
Phoenix, Arizona 85004
United StatesSite Not Available
UC San Diego Moores Cancer Center
La Jolla, California 92037
United StatesSite Not Available
UCLA
Los Angeles, California 90095
United StatesSite Not Available
Hoag Memorial Presbyterian Hospital
Newport Beach, California 92663
United StatesSite Not Available
UC Davis Comprehensive Cancer Center
Sacramento, California 95817
United StatesSite Not Available
California Pacific Medical Center - Sutter Health
San Francisco, California 94115
United StatesSite Not Available
Yale New Haven Hospital
New Haven, Connecticut 06510
United StatesSite Not Available
University of Chicago Medical Center
Chicago, Illinois 60637
United StatesSite Not Available
Elmhurst Memorial Hospital - Nancy W. Knowles Cancer Center
Elmhurst, Illinois 60126
United StatesSite Not Available
Edward Cancer Center
Naperville, Illinois 60540
United StatesSite Not Available
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana 48202
United StatesSite Not Available
University of Kansas Hospital
Westwood, Kansas 66205
United StatesSite Not Available
Norton Cancer Institute, Audubon Hospital Campus
Louisville, Kentucky 40217
United StatesSite Not Available
Maine Health Cancer Care
South Portland, Maine 04106
United StatesSite Not Available
University of Massachusetts
Worcester, Massachusetts 01655
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Saint Luke's Hospital
Kansas City, Missouri 64111
United StatesSite Not Available
University of Nebraska Medical Center
Omaha, Nebraska 68105
United StatesSite Not Available
New Mexico Cancer Care Alliance
Albuquerque, New Mexico 87131
United StatesSite Not Available
NYU Langone Health
New York, New York 11735
United StatesSite Not Available
Stony Brook University
Stony Brook, New York 11794
United StatesSite Not Available
SUNY Upstate Medical University
Syracuse, New York 13210
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
Reading Hospital McGlinn Cancer Institute
West Reading, Pennsylvania 19611
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
Baylor Scott & White Medical Center
Temple, Texas 76508
United StatesSite Not Available
Renovatio Clinic
The Woodlands, Texas 77380
United StatesSite Not Available
Inova Schar Cancer Institute
Fairfax, Virginia 22031
United StatesSite Not Available
University of Washington Medical Center
Seattle, Washington 98195
United StatesSite Not Available
Virginia Mason Medical Center
Seattle, Washington 98101
United StatesSite Not Available
West Virginia University
Morgantown, West Virginia 26506
United StatesSite Not Available

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