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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: Recruiting Phase 1 study of Pancreatic Cancer, sponsored by NYU Langone Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
A dose-limiting toxicity (DLT) is defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 8 weeks of study treatment. NCI CTCAE v5.0 will be used for all grading.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-07-14 |
| Est. Completion | 2026-01-01 |
| Phase | Phase 1 |
What NCT05984602 shows while recruiting
NCT05984602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Pancreatic Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05984602's enrollment target sits among peer trials
10 263rd of 278 higher than 12 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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