Pancreatic CancerPhase 1NCT05984602
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 testing Canakinumab, Tislelizumab and Nab-Paclitaxel in people with Pancreatic Cancer, run by NYU Langone Health at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Canakinumab, Tislelizumab and Nab-Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Jul 2023to 1 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- - Diagnosis of pancreatic neuroendocrine carcinoma or pancreatic acinar cell carcinoma.
- Determined by the medical or surgical team to be a poor candidate for future surgical resection
- Has locally advanced or metastatic disease as determined by imaging
- o This includes those with a baseline CA 19-9 level > 1000 as these subjects have a high rate of metastatic disease
- Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) for pancreatic cancer.
- Known microsatellite instability-high (MSI-H) or mismatch repair-deficient pancreatic cancer
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- Any prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1 inhibitor).
- Administration of a live vaccine within 30 days of the first dose of therapy on study
- History of known hypersensitivity to any of the drugs used in this study or any of their excipients, or patient has contraindication to any of the study drugs as outlined in the local prescribing information (e.g. United States Prescribing Information [USPI])
- Active autoimmune disease that has required systemic treatment in the past 2 years prior to enrollment i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs. Control of the disorder with replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is permitted.
- Patient has concurrent malignancy other than the disease under investigation, with exception of malignancy that was treated curatively and has not recurred within 2 years prior to the date of screening. Fully resected basal or squamous cell skin cancers, and any carcinoma in situ are eligible.
- Subjects with a history of pneumonitis or interstitial lung disease requiring therapy
- Patient with suspected or proven immunocompromised state or infections, including:
- Evidence of active or latent tuberculosis (TB) as determined by locally approved screening methods. If the results of the screening per local treatment guidelines or clinical practice require treatment, then the patient is not eligible.
- Known history of testing positive for Human Immunodeficiency Virus (HIV) infections.
- Any other medical condition (such as active infection, treated or untreated), which in the opinion of the investigator places the patient at an unacceptable risk for participation in immunomodulatory therapy.
- Note: Patients with localized condition unlikely to lead to a systemic infection e.g. chronic nail fungal infection are eligible.
- Pre-existing peripheral neuropathy > Grade 1 (CTCAE V 5.0)
- Allogeneic bone marrow or solid organ transplant
- Uncontrolled or severe cardiac disease. e (history of unstable angina, myocardial infarction, coronary stenting, or bypass surgery within the prior 6 months), symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia [including atrial flutter/fibrillation], requirement for inotropic support or use of devices for cardiac conditions [pacemakers/defibrillators]), uncontrolled hypertension defined by a systolic blood pressure =>160 mg and/or diastolic blood pressure =>100 mg Hg.
- Any significant medical condition, laboratory abnormality or psychiatric condition that would constitute unacceptable safety risks to the patients, contraindicate patient participation in the clinical study, limit the patient's ability to comply with study requirements, or compromise patient's compliance with the protocol and all requirements of the study as stated in the Informed Consent Form.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ambulatory Care Center
New York, New York, 10016
Clinical Cancer Center
New York, New York, 10016
NYU Langone Ambulatory Care Center East 38th Street
New York, New York, 10016
About this study
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
Read more
Participants will have labs drawn, CT scans, and a treatment administered consisting of:
- Gemcitabine
- Nab-paclitaxel
- Canakinumab
- Tislelizumab
- Conditions
- Pancreatic Cancer
- Being tested
- Canakinumab, Tislelizumab, Nab-Paclitaxel, Gemcitabine
- Keywords
- Pancreatic Cancer, GI cancer
- Medical subject headings
- Pancreatic Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanakinumabDrug
Also called ACZ885
250 mg subcutaneous injection in prefilled syringes on day 1 of every 28-day cycle
TislelizumabDrug
300 mg in a liquid vial (concentrate for intravenous (i.v.) solution) on day 1 of every 28-day cycle
Nab-PaclitaxelDrug
125 mg/m2 intravenous infusion on days 1, 8, 15 of every 28-day cycle
GemcitabineDrug
1000 mg/m2 intravenous infusion on days 1, 8, 15 of every 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Quadruplet regimen prior to resection for pancreatic cancer | Experimental | Treatment of Canakinumab and Tislelizumab in Combination with Nab-Paclitaxel and Gemcitabine up to 4 cycles (4 months) Receives: Drug: Canakinumab; Drug: Tislelizumab; Drug: Nab-Paclitaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dose limiting toxicities (DLTs)
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.
Measured: 56 days
Number of patients who proceeded to surgical resection
The study team will collaborate with the surgical team to review whether there are any delays or change in outcome in surgery that is attributed to study drug.
Measured: End of treatment (up to 6 months)
Secondary outcomes (6)
Overall Response Rate (ORR)
ORR is defined as the proportion of subjects with best overall response (BOR) of complete response (CR) or partial response (PR), according to RECIST 1.1.
Measured: Up to 6 months post treatment
R0 resection rate (R0)
R0 is defined by a surgery that completely removes the visible tumor and that is deemed to be margin negative on final pathology report. If tumor is not completely removed this is will be deemed to have failed to achieve an R0 resection.
Measured: At surgery post treatment (up until 6 months)
Progression Free Survival (PFS)
PFS is defined as the time from the date of first dose to the date of the first documented disease progression based on local investigator assessment as per RECIST 1.1 (assessed by investigator) or death due to any cause.
Measured: Up to 6 months after patients last treatment
Overall Survival (OS)
OS is defined as the time from date of first dose of study treatment to date of death due to any cause. If a subject is not known to have died, then OS will be censored at the latest date the subject was known to be alive (on or before the cut-off date).
Measured: Up to 6 months after patients last treatment
Number of delays outcome of surgery that is attributed to study drug
The surgical team will review whether there are any delays in outcome in surgery that is attributed to study drug.
Measured: At surgery post treatment (up until 6 months)
Number of changes in outcome of surgery that is attributed to study drug
The surgical team will review whether there are any change in outcome in surgery that is attributed to study drug.
Measured: At surgery post treatment (up until 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start14 Jul 2023
- Primary completion1 Sep 2025
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Oberstein, MD, Principal investigator, Perlmutter New York University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984602
- Sponsor's protocol ID
- 22-01205
- Status last verified
- Mar 2026
- First submitted
- 2 Aug 2023
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: to Paul.Oberstein@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05984602
- Acronym / sponsor ID
- 22-01205
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, GI cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quadruplet regimen prior to resection for pancreatic cancer | Experimental | Drug: Canakinumab, Drug: Tislelizumab, Drug: Nab-Paclitaxel, Drug: GemcitabineTreatment of Canakinumab and Tislelizumab in Combination with Nab-Paclitaxel and Gemcitabine up to 4 cycles (4 months) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (21 listed)
- - Diagnosis of pancreatic neuroendocrine carcinoma or pancreatic acinar cell carcinoma.
- Determined by the medical or surgical team to be a poor candidate for future surgical resection
- Has locally advanced or metastatic disease as determined by imaging
- o This includes those with a baseline CA 19-9 level > 1000 as these subjects have a high rate of metastatic disease
- Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) for pancreatic cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CanakinumabAlso: ACZ885250 mg subcutaneous injection in prefilled syringes on day 1 of every 28-day cycle | Drug | Quadruplet regimen prior to resection for pancreatic cancer |
| Tislelizumab300 mg in a liquid vial (concentrate for intravenous (i.v.) solution) on day 1 of every 28-day cycle | Drug | Quadruplet regimen prior to resection for pancreatic cancer |
| Nab-Paclitaxel125 mg/m2 intravenous infusion on days 1, 8, 15 of every 28-day cycle | Drug | Quadruplet regimen prior to resection for pancreatic cancer |
| Gemcitabine1000 mg/m2 intravenous infusion on days 1, 8, 15 of every 28-day cycle | Drug | Quadruplet regimen prior to resection for pancreatic cancer |
Primary outcome
Number of dose limiting toxicities (DLTs)
Time frame: 56 days
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.
Number of patients who proceeded to surgical resection
Time frame: End of treatment (up to 6 months)
The study team will collaborate with the surgical team to review whether there are any delays or change in outcome in surgery that is attributed to study drug.
6 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 6 months post treatment
R0 resection rate (R0)
Time frame: At surgery post treatment (up until 6 months)
Progression Free Survival (PFS)
Time frame: Up to 6 months after patients last treatment
Overall Survival (OS)
Time frame: Up to 6 months after patients last treatment
Number of delays outcome of surgery that is attributed to study drug
Time frame: At surgery post treatment (up until 6 months)
Number of changes in outcome of surgery that is attributed to study drug
Time frame: At surgery post treatment (up until 6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: to Paul.Oberstein@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Oberstein, MD principal investigator
Perlmutter New York University Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Canakinumab, Tislelizumab and Nab-Paclitaxel in people with Pancreatic Cancer, run by NYU Langone Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of dose limiting toxicities (DLTs) (time frame: 56 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026; AzTrials last refreshed its copy on 2 Nov 2026.