Phase 3
N=284
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
Bottom Line
View on ClinicalTrials.gov: NCT03941093 ↗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
| Outcome | Result | p-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
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.