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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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 locally advanced, unresectable pancreatic cancer subjects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FibroGen
• Treatments: Albumin-Bound Paclitaxel; Fluorouracil; Folfirinox; Gemcitabine; Irinotecan; Leucovorin; Levoleucovorin; Paclitaxel

Criteria

Inclusion Criteria:

1. Understand and sign informed consent; be willing to comply with study procedures, including surgery

2. Age ≥ 18 years

3. Be a male, or non-pregnant and non-lactating female

4. Negative serum B-hCG pregnancy test at screening for women of childbearing potential

5. 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

6. Histologically or cytologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)

7. Locally advanced pancreatic cancer considered unresectable according to NCCN Guidelines® Version 2.2018 as determined by central imaging

8. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors RECIST 1.1 criteria as determined by central imaging

9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

10. 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

11. Adequate bone marrow function: platelets >100,000 cells/mm3, hemoglobin >9.0 g/dl and absolute neutrophil count (ANC) >1,500 cells/mm3

12. Adequate renal function: creatinine < 1.5 x ULN, creatinine clearance ≥ 30 mL/min

13. Less than grade 2 pre-existing peripheral neuropathy (per CTCAE)

Exclusion Criteria:

1. Prior chemotherapy or radiation for pancreatic cancer

2. Previous (within the past 3 years) or concurrent malignancy diagnosis except non-melanoma skin cancer and in situ carcinomas (excluding in situ breast cancer)

3. Major surgery within 4 weeks prior to signing informed consent form. Biliary stents are permitted.

4. History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies

5. History of allergy or hypersensitivity to any of the chemotherapy agents being prescribed or their excipients

6. Any medical or surgical condition that may place the subject at increased risk while on study

7. Any condition potentially decreasing compliance to study procedures

8. Exposure to another investigational drug within 28 days of first dosing visit, or 5 half-lives of the investigational drug (whichever is longer)

9. 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

10. Documented history of drug or alcohol abuse within 6 months of signing informed consent

11. 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

12. Subjects with a history of; interstitial pulmonary disease, HCV, HBV or HIV infection

13. Subjects who have been administered a live vaccine within four weeks prior to the first administration of therapy

14. Subjects who cannot stop chronic medications that inhibit or induce CYP2C8 or CYP3A4

15. 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