RecruitingPhase 1NCT05984602

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


Sponsor

NYU Langone Health

Enrollment

10 participants

Start Date

Jul 14, 2023

Study Type

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

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding canakinumab (an anti-inflammatory drug) and tislelizumab (an immunotherapy drug) to standard chemotherapy (nab-paclitaxel and gemcitabine) before surgery improves outcomes for people with resectable or borderline resectable pancreatic cancer. **You may be eligible if:** - You are 18 or older with a confirmed diagnosis of pancreatic ductal adenocarcinoma (a common type of pancreatic cancer) - Your tumor is confined to the pancreas and may be removable by surgery - You have not yet received any prior treatment for pancreatic cancer - Your general health is good (ECOG score 0–1) - Your organ function (blood counts, kidneys, liver) meets minimum requirements **You may NOT be eligible if:** - Your pancreatic cancer has spread beyond the pancreas to distant organs - You have active autoimmune disease or are on immunosuppressive therapy - You are pregnant or breastfeeding - You have serious infections or active inflammatory conditions Talk to your doctor to see if this trial is right for you.

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

DRUGCanakinumab

250 mg subcutaneous injection in prefilled syringes on day 1 of every 28-day cycle

DRUGTislelizumab

300 mg in a liquid vial (concentrate for intravenous (i.v.) solution) on day 1 of every 28-day cycle

DRUGNab-Paclitaxel

125 mg/m2 intravenous infusion on days 1, 8, 15 of every 28-day cycle

DRUGGemcitabine

1000 mg/m2 intravenous infusion on days 1, 8, 15 of every 28-day cycle


Locations(3)

NYU Langone Ambulatory Care Center East 38th Street

New York, New York, United States

Ambulatory Care Center

New York, New York, United States

Clinical Cancer Center

New York, New York, United States

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NCT05984602


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