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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT05984602•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

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Exclusion Criteria

•\- Diagnosis of pancreatic neuroendocrine carcinoma or pancreatic acinar cell carcinoma.
•Determined by the medical or surgical team to be a poor candidate for future surgical resection
•Has locally advanced or metastatic disease as determined by imaging
•o This includes those with a baseline CA 19-9 level \> 1000 as these subjects have a high rate of metastatic disease
•Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) for pancreatic cancer.
•Known microsatellite instability-high (MSI-H) or mismatch repair-deficient pancreatic cancer
•Any prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1 inhibitor).
•Administration of a live vaccine within 30 days of the first dose of therapy on study
•History of known hypersensitivity to any of the drugs used in this study or any of their excipients, or patient has contraindication to any of the study drugs as outlined in the local prescribing information (e.g. United States Prescribing Information \[USPI\])
•Active autoimmune disease that has required systemic treatment in the past 2 years prior to enrollment i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs. Control of the disorder with replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is permitted.
+10 more criteria

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

Key Dates

Start Date

July 14, 2023

Primary Completion Date

August 1, 2025

Completion Date

January 1, 2026

Last Updated

April 15, 2025

Enrollment

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

Canakinumab

DRUG

Tislelizumab

DRUG

Nab-Paclitaxel

DRUG

Gemcitabine

DRUG

Contacts

Sandra John-Henry

CONTACT

212-263-4432 Sandra.John-Henry@nyulangone.org

Study Listserv

CONTACT

#GICCU@nyulangone.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

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