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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
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
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
Number of dose limiting toxicities (DLTs)
A dose-limiting toxicity (DLT) is defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 8 weeks of study treatment. NCI CTCAE v5.0 will be used for all grading.
Time frame: 56 days
Number of patients who proceeded to surgical resection
The study team will collaborate with the surgical team to review whether there are any delays or change in outcome in surgery that is attributed to study drug.
Time frame: End of treatment (up to 6 months)
Overall Response Rate (ORR)
ORR is defined as the proportion of subjects with best overall response (BOR) of complete response (CR) or partial response (PR), according to RECIST 1.1.
Time frame: Up to 6 months post treatment
R0 resection rate (R0)
R0 is defined by a surgery that completely removes the visible tumor and that is deemed to be margin negative on final pathology report. If tumor is not completely removed this is will be deemed to have failed to achieve an R0 resection.
Time frame: At surgery post treatment (up until 6 months)
Progression Free Survival (PFS)
PFS is defined as the time from the date of first dose to the date of the first documented disease progression based on local investigator assessment as per RECIST 1.1 (assessed by investigator) or death due to any cause.
Time frame: Up to 6 months after patients last treatment
Overall Survival (OS)
OS is defined as the time from date of first dose of study treatment to date of death due to any cause. If a subject is not known to have died, then OS will be censored at the latest date the subject was known to be alive (on or before the cut-off date).
Time frame: Up to 6 months after patients last treatment
Number of delays outcome of surgery that is attributed to study drug
The surgical team will review whether there are any delays in outcome in surgery that is attributed to study drug.
Time frame: At surgery post treatment (up until 6 months)
Number of changes in outcome of surgery that is attributed to study drug
The surgical team will review whether there are any change in outcome in surgery that is attributed to study drug.
Time frame: At surgery post treatment (up until 6 months)
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