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ACTIVE NOT RECRUITING
NCT05984602
PHASE1

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

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2023-07-14

Completion Date

2026-07-01

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DRUG

Canakinumab

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

DRUG

Tislelizumab

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

DRUG

Nab-Paclitaxel

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

DRUG

Gemcitabine

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

Locations (3)

Ambulatory Care Center

New York, New York, United States

Clinical Cancer Center

New York, New York, United States

NYU Langone Ambulatory Care Center East 38th Street

New York, New York, United States