A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Comb… (NCT05984602) | Clinical Trial Compass
Active — Not RecruitingPhase 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
United States9 participantsStarted 2023-07-14
Plain-language 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
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of dose limiting toxicities (DLTs)
Timeframe: 56 days
2
Number of patients who proceeded to surgical resection