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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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 be confirmed as negative, a serum pregnancy test will be required. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 9 months after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year

Locations
United States
New York
Ambulatory Care Center
RECRUITING
New York
Clinical Cancer Center
RECRUITING
New York
NYU Langone Ambulatory Care Center East 38th Street
RECRUITING
New York
Contact Information
Primary
Sandra John-Henry
Sandra.John-Henry@nyulangone.org
212-263-4432
Backup
Study Listserv
#GICCU@nyulangone.org
Time Frame
Start Date: 2023-07-14
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 10
Treatments
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)
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health

This content was sourced from clinicaltrials.gov