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NCT05984602 · ClinicalTrials.gov registry record · Phase 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

A Phase 1 study of Pancreatic Cancer, sponsored by NYU Langone Health.

Recruiting
Registry status
Phase 1
Development phase
10
Enrollment target
3
Study locations

NCT05984602 is a Phase 1 study of Pancreatic Cancer that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 10 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 1 state.

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The verdict

NCT05984602, a Phase 1 study of Pancreatic Cancer, is actively recruiting participants, sponsored by NYU Langone Health.

RECRUITING
Registry status
Phase 1
Development phase
10 participants
Enrollment target
3
Study locations

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 Studied

Pancreatic Cancer

Interventions

  • DRUG Tislelizumab
  • DRUG Nab-Paclitaxel
  • DRUG Canakinumab
  • DRUG Gemcitabine

Study Locations (3)

New York

  • Ambulatory Care Center - New York
  • Clinical Cancer Center - New York
  • NYU Langone Ambulatory Care Center East 38th Street - New York

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2023-07-14
Est. Completion 2026-01-01
Phase Phase 1

Sponsor

NYU Langone Health

1,164 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05984602

The ClinicalTrials.gov registry entry for NCT05984602 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (97% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pancreatic Cancer appearing as the primary indexed condition, and to 4 interventions - of which Tislelizumab is the first listed.

NCT05984602 reports 3 study locations spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT05984602 about?

NCT05984602 is a clinical study titled "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". 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: * Determ...

What is the current status of trial NCT05984602?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2023-07-14. Estimated completion is 2026-01-01.

What conditions does trial NCT05984602 study?

This clinical trial studies the following conditions: Pancreatic Cancer.

What interventions are being tested in trial NCT05984602?

The interventions under investigation include: Tislelizumab (DRUG), Nab-Paclitaxel (DRUG), Canakinumab (DRUG), Gemcitabine (DRUG).

Who is sponsoring clinical trial NCT05984602?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05984602 being conducted?

This trial has 3 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.