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Phase 3 N=284 Randomized Quadruple-blind Treatment

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

Pancreatic Cancer Non-resectable

Enrolled (actual)
284
Serious AEs
48.4%
Results posted
Nov 2024
Primary outcome: Primary: Overall Survival — 17.25; 17.94 months — p=0.5487

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX (Drug); Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Kyntra Bio
Primary completion
Jun 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Survival
17.25; 17.94 0.5487
SECONDARY
Event-free Survival (EFS)
5.72; 5.78
SECONDARY
Progression-free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
9.36; 9.40
SECONDARY
Number of Participants With Best Overall Objective Response as Assessed Using RECIST v1.1
43; 64

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.

Eligibility Criteria

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 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) 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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03941093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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