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Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Gemcitabine and Nab-paclitaxel) 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 gemcitabine plus nab-paclitaxel (G / NP) 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 double barrier contraception methods during the conduct of the study and for 3 months after the last dose of study drug
  • Histologically 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
  • 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
  • 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

California

Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Charlean Ketchens
Phone: 323-865-3035
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Cristina de Leon
Phone: 949-764-5543
Newport Beach
Hoag Memorial Hospital
Status: ACTIVE
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

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: APPROVED
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

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

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 G/NP or placebo with G/NP. 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. 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