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
NYU Langone Health
10 participants
Jul 14, 2023
INTERVENTIONAL
Conditions
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
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
250 mg subcutaneous injection in prefilled syringes on day 1 of every 28-day cycle
300 mg in a liquid vial (concentrate for intravenous (i.v.) solution) on day 1 of every 28-day cycle
125 mg/m2 intravenous infusion on days 1, 8, 15 of every 28-day cycle
1000 mg/m2 intravenous infusion on days 1, 8, 15 of every 28-day cycle
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT05984602