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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

NCT05984602 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-03-30

No results posted yet for this study

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

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Paul Oberstein, MD · Perlmutter New York University Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-14
Primary Completion
2025-09-01
Completion
2026-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05984602 on ClinicalTrials.gov