A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Combination With Nab-Paclitaxel and Gemcitabine in the Neo-adjuvant Treatment of Patients With Pancreatic Cancer

• Status: RECRUITING
• Trial end date: 2026-01-01

Summary

The goal of this Single Arm Phase Ib clinical trial is to test standard of care chemotherapy and anti PD1 and IL1b to evaluate the safety and preliminary toxicity of this quadruplet regimen prior to resection in patients with pancreatic cancer. The main objectives it aims to answer are to:

• Determine the recommended Phase II dose regimen of canakinumab and tislelizumab in combination with gemcitabine and nab-paclitaxel in patients with localized pancreatic ductal adenocarcinoma.
• Estimate the proportion of patients who proceed to surgical resection.
• Determine the safety and tolerability of canakimumab in combination with tislelizumab, nab-paclitaxel and gemcitabine
• Assess the preliminary clinical anti-tumor activity of canakimumab in combination with tislelizumab, nab-paclitaxel and gemcitabine
• Assess whether therapy has any impact on surgical options

Participants will have labs drawn, CT scans, and a treatment administered consisting of:

• Gemcitabine
• Nab-paclitaxel
• Canakinumab
• Tislelizumab

• Phase: PHASE1

Details

• Lead Sponsor: NYU Langone Health
• Treatments: 130-nm albumin-bound paclitaxel; canakinumab; Gemcitabine; tislelizumab