Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT05984602
Brief 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
Study:
NCT05984602
Study Brief:
Protocol Section:
NCT05984602