Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced, Unresectable Pancreatic Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

284

Participants

Timeline

Start Date

May 10, 2019

Primary Completion Date

June 11, 2024

Study Completion Date

June 11, 2024

Conditions
Pancreatic Cancer Non-resectable
Interventions
DRUG

Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX

"Drug: Pamrevlumab is administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion.~Drug: Gemcitabine is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion.~Drug: Nab-paclitaxel is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion.~Drug: FOLFIRINOX is a combination of several agents administered on Days 1 and 15 of each 28 day treatment cycle via IV infusion. The specific agents are Oxaliplatin, Folinic Acid, Irinotecan, and Fluorouracil."

DRUG

Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX

"Drug: Placebo is administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion.~Drug: Gemcitabine is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion.~Drug: Nab-paclitaxel is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion.~Drug: FOLFIRINOX is a combination of several agents administered on Days 1 and 15 of each 28 day treatment cycle via IV infusion. The specific agents are Oxaliplatin, Folinic Acid, Irinotecan, and Fluorouracil."

Trial Locations (90)

1070

CUB Hôpital Erasme, Brussels

1090

Medizinische Universität Wien, Vienna

4600

Klinikum Wels-Grieskirchen GmbH, Wels

8041

Hospital de la Santa Creu i Sant Pau, Barcelona

10117

Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie, Berlin

10408

National Cancer Center, Goyang-si

11735

NYU Langone Health, New York

11794

Stony Brook University, Stony Brook

13210

SUNY Upstate Medical University, Syracuse

13620

Seoul National University Budang Hospital, Seongnam-si

15212

Allegheny General Hospital, Pittsburgh

17007

Institut Catalá d'Oncologia (ICO Girona). Hospital Dr. Josep Trueta, Girona

19107

Thomas Jefferson University, Philadelphia

19611

Reading Hospital McGlinn Cancer Institute, West Reading

20089

Istituto Clinico Humanitas, Rozzano

20132

IRCCS Ospedale San Raffaele, Milan

20141

Istituto Europeo di Oncologia, Milan

20162

Grande Ospedale Metropolitano Niguarda, Oncologia Medica Falck, Milan

21079

Centre Georges-François Leclerc, Dijon

22031

Inova Schar Cancer Institute, Fairfax

25030

CHRU Jean Minjoz, Besançon

26506

West Virginia University, Morgantown

28007

Hospital General Universitario Gregorio Marañon, Madrid

28033

MD Anderson Cancer Center, Madrid

28040

Hospital Clinico San Carlos, Madrid

33604

Haut-Lévêque, Pessac

36312

Alvaro Cunqueiro Hospital, Vigo

37134

CRC di Verona, Verona

38700

CHU Grenoble Alpes, La Tronche

40217

Norton Cancer Institute, Audubon Hospital Campus, Louisville

43210

Ohio State University, Columbus

44805

Institut de Cancérologie de l'Ouest Pays de Loire, Saint-Herblain

45219

University of Cincinnati Medical Center, Cincinnati

46010

Hospital Clinico Universitario de Valencia, Valencia

47014

Instituto Scientifico Romagnolog per lo Studio e la Cura dei Tumori, Meldola

48109

University of Michigan, Ann Arbor

48201

Karmanos Cancer Institute, Detroit

48202

Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis

50009

Hospital Universitario Miguel Servet, Zaragoza

58128

Chonnam National University Hwasun Hospital, Hwasun

60126

Elmhurst Memorial Hospital - Nancy W. Knowles Cancer Center, Elmhurst

60540

Edward Cancer Center, Naperville

63003

CHU Estaing, Clermont-Ferrand

64111

Saint Luke's Hospital, Kansas City

66205

University of Kansas Hospital, Westwood

68105

University of Nebraska Medical Center, Omaha

69373

Centre Léon Bérard, Lyon

69437

Hôpital Edouard Herriot, Lyon

76508

Baylor Scott & White Medical Center, Temple

77030

Baylor College of Medicine, Houston

77380

Renovatio Clinic, The Woodlands

80131

AOU Federico II, Napoli

81377

Klinikum der Universität München, Medizinische Klinik und Poliklinik III, München

81675

Klinikum rechts der Isar der Technischen Universität München, München

85004

St. Joseph's Hospital and Medical Cancer Center, Phoenix

87131

New Mexico Cancer Care Alliance, Albuquerque

90095

UCLA, Los Angeles

92037

UC San Diego Moores Cancer Center, La Jolla

92118

Hopital BEAUJON, Clichy

95817

UC Davis Comprehensive Cancer Center, Sacramento

98101

Virginia Mason Medical Center, Seattle

98195

University of Washington Medical Center, Seattle

100010

Peking Union Medical College Hospital, Dongcheng

200040

Huashan Hospital affiliated with Fudan University, Jing’an

750013

Groupe Hospitalier Pitié Salpêtrière, Paris

4428164

Meir Medical center, Kfar Saba

4941492

Rabin Medical Center, Petah Tikva

7030000

Shamir Medical center Asaf Harofeh, Be’er Ya‘aqov

9112001

Hadassah University Hospital Ein Kerem, Jerusalem

06510

Yale New Haven Hospital, New Haven

04106

Maine Health Cancer Care, South Portland

01655

University of Massachusetts, Worcester

K1H 8L6

The Ottawa Hospital, Ottawa

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5G 2M9

Princess Margaret Cancer Centre/University Health Network, Toronto

H4A 3J1

McGill University Health Center, Montreal

Unknown

Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan

The First Affiliated Hospital Of Xi'an Jiaotong University, Xi'an

West China Hospital of Sichuan University, Chengdu

Jiangsu Province Hospital, Nanjing

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

Xinhua Hospital Affiliated to Shanghai Jiaotong University School Of Medicine, Shanghai

01307

Technische Universität Dresden, Medizinische Klinik und Poliklinik I, Dresden

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

08035

Hospital Universitaro Vall D'Hebron, Barcelona

NW1 2PG

University College London Hospitals NHS Foundation Trust, London

W2 1NY

Imperial College Healthcare NHS Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

FibroGen

INDUSTRY

NCT03941093 - Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced, Unresectable Pancreatic Cancer | Biotech Hunter | Biotech Hunter