Active — Not RecruitingPhase 1

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

United States9 participantsStarted 2023-07-14

Plain-language 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

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18 years at the time of informed consent * Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) as determined by a local laboratory (adenosquamous is also allowed). * Tumor confined to the pancreas and deemed resectable or borderline resectable per NCCN guidelines for these criteria. * Patients must have not received previous anti-cancer therapy for the treatment of pancreatic ductal adenocarcinoma. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Adequate organ function (laboratory results must be obtained within the 21-day screening window) including hematologic, renal and hepatic function. * Absolute neutrophil count \> 1500/mm3 * Platelets \> 100,000/mm3 * Calculated creatinine clearance \> 60 mL/min (Cockcroft Gault) * Albumin \> 3.0 g/dL * Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) \< 3.0 x ULN * Total bilirubin ≤ 1.5 X ULN * Able to adhere to study visit schedule and other protocol requirements * Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy * Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot…

What they're measuring

Number of dose limiting toxicities (DLTs)

Timeframe: 56 days

Number of patients who proceeded to surgical resection

Timeframe: End of treatment (up to 6 months)

Trial details

NCT IDNCT05984602

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01