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

Trial Status: Active

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 locally advanced, unresectable pancreatic cancer subjects.

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 subjects with partners of childbearing potential and female subjects 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 Response Evaluation Criteria in Solid Tumors 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 subjects 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)

Exclusion Criteria

  • 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 subject 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 subject in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation
  • Subjects with a history of; interstitial pulmonary disease, HCV, HBV or HIV infection
  • Subjects who have been administered a live vaccine within four weeks prior to the first administration of therapy
  • Subjects who cannot stop chronic medications that inhibit or induce CYP2C8 or CYP3A4
  • Subjects 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

California

Los Angeles
Los Angeles County-USC Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Charlean Ketchens
Phone: 323-865-3035
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Louis Slonlker
Phone: 310-794-8582
USC / Norris Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Cristina de Leon
Phone: 949-764-5543
Newport Beach
Hoag Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Charlean Ketchens
Phone: 323-865-3035
Sacramento
University of California Davis Comprehensive Cancer Center
Status: ACTIVE
San Diego
University of California San Diego
Status: ACTIVE

Connecticut

New Haven
Yale University
Status: ACTIVE

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE
Contact: Matthew Truman Edison
Phone: 317-274-5725

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Benjamin R. Roberts
Phone: 913-588-6939

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: ACTIVE

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: ACTIVE

Texas

Houston
Ben Taub General Hospital
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Subjects will be randomized in a 1:1 ratio to one of the two study treatment arms;

pamrevlumab with either G/NP or FOLFIRINOX, placebo with G/NP or FOLFIRINOX.

Each subject may receive up to six cycles of treatment (each treatment cycle is 28 days).

Tumor tissue will be collected during resection to determine surgical outcome and for

biomarker analysis. Tumor response will be evaluated by changes in CT scan, FDG-PET, CA 19-9,

and NCCN® guidelines.

All subjects randomized will have a safety follow-up visit approximately 28 days after the

last dose of study treatment and a final safety follow-up phone call at approximately 60 days

after the last dose.

Subjects who complete 6 cycles of treatment will be evaluated for surgical exploration for

possible R0 or R1 resection. Surgery will occur at least 4 weeks after the last dose

(allowing for a wash-out period from treatment) and only after receipt of the recommendation

from the central review board with regards to surgical eligibility. Surgery will occur no

longer than 8 weeks after the last dose. Subjects who undergo surgery will be evaluated for

surgical complications for at least an additional 90 days following discharge from surgery.

Subjects who are ineligible for surgical exploration (i.e. subjects who did not complete 6

cycles of treatment or do not meet any of the protocol defined criteria or had a

contraindication to surgery) will continue in the Follow-up period and receive treatment as

per standard of care (SOC) for each institution.

All subjects will be followed for disease progression (if not previously detected) or

recurrence following resection (local progression or metastatic disease). Subjects will also

be followed for any additional anti-cancer therapy received for their pancreatic cancer. All

subjects will be followed for survival (until death) or until the last subject to complete

treatment reaches 18 months post-treatment.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
FibroGen

  • Primary ID FGCL-3019-087
  • Secondary IDs NCI-2019-03185
  • Clinicaltrials.gov ID NCT03941093