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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT05984602
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Canakinumab — DRUG
    250 mg subcutaneous injection in prefilled syringes on day 1 of every 28-day cycle
  • Tislelizumab — DRUG
    300 mg in a liquid vial (concentrate for intravenous (i.v.) solution) on day 1 of every 28-day cycle
  • Nab-Paclitaxel — DRUG
    125 mg/m2 intravenous infusion on days 1, 8, 15 of every 28-day cycle
  • Gemcitabine — DRUG
    1000 mg/m2 intravenous infusion on days 1, 8, 15 of every 28-day cycle

Study Details

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 Dates

Start date
Jul 14, 2023
Status verified
Mar 2026
Primary completion
Sep 1, 2025
Completion
Jul 1, 2026

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Quadruplet regimen prior to resection for pancreatic cancer
    Treatment of Canakinumab and Tislelizumab in Combination with Nab-Paclitaxel and Gemcitabine up to 4 cycles (4 months)

Primary Outcome Measure

Number of dose limiting toxicities (DLTs) [ Time Frame: 56 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
Ambulatory Care CenterNew YorkNew York10016-
Clinical Cancer CenterNew YorkNew York10016-
NYU Langone Ambulatory Care Center East 38th StreetNew YorkNew York10016-

Find similar trials in New York, NY

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Ambulatory Care Center· New York, NYClinical Cancer Center· New York, NYNYU Langone Ambulatory Care Center East 38th Street· New York, NY

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