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

NCT03941093 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: FGCL-3019-087
• Study Type: interventional
• Target: 284
• Locations: 12 countries
• Sites: 90

Brief Summary

This is a Phase 3, randomized, double-blind trial to evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab or placebo in combination with either gemcitabine plus nab-paclitaxel (G/NP) or FOLFIRINOX in the treatment of participants with locally advanced, unresectable pancreatic cancer.

Conditions

Pancreatic Cancer Non-resectable

Keywords

locally advanced pancreatic cancer; unresectable pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival was defined as the time from date of randomization to date of death due to any cause. Overall survival was calculated using the Kaplan-Meier method.

  Up to approximately 5 years

Secondary Outcomes (3)

• Event-free Survival (EFS)

  Up to approximately 5 years

• Progression-free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Up to approximately 5 years

• Number of Participants With Best Overall Objective Response as Assessed Using RECIST v1.1

  Up to approximately 5 years

Study Arms (2)

Arm A

EXPERIMENTAL

Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX

Drug: Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX

Arm B

PLACEBO COMPARATOR

Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX

Drug: Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX

Interventions

Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX DRUG

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.

Also known as: FG-3019, Gemzar, Abraxane, Eloxitan, Leucovorin, Camptosar, 5-Fluracil, Efudex

Arm A

Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX DRUG

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.

Also known as: Gemzar, Abraxane, Eloxitan, Leucovorin, Camptosar, 5-Fluracil, Efudex

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 of childbearing potential are required to use highly effective contraception methods during 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 NCCN Guidelines® Version 2.2018 as determined by central imaging
• Measurable disease as defined by RECIST 1.1 criteria as determined by central imaging
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2.5 x upper limit of normal (ULN), alkaline phosphatase \<2.5 x 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/dl and 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)

You may not qualify if:

• Prior chemotherapy or radiation for pancreatic cancer
• Previous (within the past 3 years) or concurrent malignancy diagnosis except non-melanoma skin cancer and in situ carcinomas (excluding in situ breast cancer)
• Major surgery within 4 weeks prior to signing informed consent form. Biliary stents are permitted.
• History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
• History of allergy or hypersensitivity to any of the chemotherapy agents being prescribed or their excipients
• Any medical or surgical condition that may place the participant at increased risk while on study
• Any condition potentially decreasing compliance to study procedures
• Exposure to another investigational drug within 28 days of first dosing visit, or 5 half-lives of the investigational drug (whichever is longer)
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infections, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Documented history of drug or alcohol abuse within 6 months of signing informed consent
• Any medical condition that, in the opinion of the investigator, may pose a safety risk to a participant in this trial, may confound the assessment of safety and efficacy, 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 the first 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 heart failure (CHF), chronic obstructive pulmonary disease (COPD), uncontrolled diabetes mellitus (DM) or neurologic disorders (not acutely related to pancreatic cancer) or limited function

Sponsors & Collaborators

• Kyntra Bio: lead

Study Sites (90)

St. Joseph's Hospital and Medical Cancer Center

Phoenix, Arizona, 85004, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92037, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Elmhurst Memorial Hospital - Nancy W. Knowles Cancer Center

Elmhurst, Illinois, 60126, United States

Location

Edward Cancer Center

Naperville, Illinois, 60540, United States

Location

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 48202, United States

Location

University of Kansas Hospital

Westwood, Kansas, 66205, United States

Location

Norton Cancer Institute, Audubon Hospital Campus

Louisville, Kentucky, 40217, United States

Location

Maine Health Cancer Care

South Portland, Maine, 04106, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68105, United States

Location

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, 87131, United States

Location

NYU Langone Health

New York, New York, 11735, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Reading Hospital McGlinn Cancer Institute

West Reading, Pennsylvania, 19611, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Baylor Scott & White Medical Center

Temple, Texas, 76508, United States

Location

Renovatio Clinic

The Woodlands, Texas, 77380, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Medizinische Universität Wien

Vienna, 1090, Austria

Location

Klinikum Wels-Grieskirchen GmbH

Wels, 4600, Austria

Location

CUB Hôpital Erasme

Brussels, 1070, Belgium

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre/University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

Location

Peking Union Medical College Hospital

Dongcheng, Beijing Municipality, 100010, China

Location

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

Wuhan, Hubei, China

Location

The First Affiliated Hospital Of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Location

Huashan Hospital affiliated with Fudan University

Jing’an, Shanghai Municipality, 200040, China

Location

West China Hospital of Sichuan University

Chengdu, China

Location

Jiangsu Province Hospital

Nanjing, China

Location

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Xinhua Hospital Affiliated to Shanghai Jiaotong University School Of Medicine

Shanghai, China

Location

CHRU Jean Minjoz

Besançon, 25030, France

Location

CHU Estaing

Clermont-Ferrand, 63003, France

Location

Hopital BEAUJON

Clichy, 92118, France

Location

Centre Georges-François Leclerc

Dijon, 21079, France

Location

CHU Grenoble Alpes

La Tronche, 38700, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

Groupe Hospitalier Pitié Salpêtrière

Paris, 750013, France

Location

Haut-Lévêque

Pessac, 33604, France

Location

Institut de Cancérologie de l'Ouest Pays de Loire

Saint-Herblain, 44805, France

Location

Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie

Berlin, 10117, Germany

Location

Technische Universität Dresden, Medizinische Klinik und Poliklinik I

Dresden, 01307, Germany

Location

Klinikum der Universität München, Medizinische Klinik und Poliklinik III

München, 81377, Germany

Location

Klinikum rechts der Isar der Technischen Universität München

München, 81675, Germany

Location

Shamir Medical center Asaf Harofeh

Be’er Ya‘aqov, 7030000, Israel

Location

Hadassah University Hospital Ein Kerem

Jerusalem, 9112001, Israel

Location

Meir Medical center

Kfar Saba, 4428164, Israel

Location

Rabin Medical Center

Petah Tikva, 4941492, Israel

Location

Instituto Scientifico Romagnolog per lo Studio e la Cura dei Tumori

Meldola, 47014, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Grande Ospedale Metropolitano Niguarda, Oncologia Medica Falck

Milan, 20162, Italy

Location

AOU Federico II

Napoli, 80131, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

CRC di Verona

Verona, 37134, Italy

Location

Seoul National University Budang Hospital

Seongnam-si, Geyonggi-do, 13620, South Korea

Location

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

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

Seoul, 06591, South Korea

Location

Alvaro Cunqueiro Hospital

Vigo, Pontevedra, 36312, Spain

Location

Hospital Universitaro Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 8041, Spain

Location

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

Girona, 17007, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

MD Anderson Cancer Center

Madrid, 28033, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

Related Links

• Link to sponsor website

MeSH Terms

Interventions

pamrevlumab; Gemcitabine; 130-nm albumin-bound paclitaxel; folfirinox; Albumin-Bound Paclitaxel; Leucovorin; Irinotecan; Fluorouracil

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids; Uracil; Pyrimidinones

Results Point of Contact

• Title: Clinical Trial Information Desk
• Organization: FibroGen, Inc.

lapis@fibrogen.com

415-978-1337

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to one of the two study treatment arms; pamrevlumab with G/NP or FOLFIRINOX or placebo with G/NP or FOLFIRINOX.

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 7, 2019
• Study Start: May 10, 2019
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2024
• Last Updated: November 5, 2024
• Results First Posted: November 5, 2024

Record last verified: 2024-09

Locations

CN (8); DE (4); IT (7); CA (4); BE (1); US (32); KR (7); IL (4); AU (2); ES (9); FR (10); GB (2)