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
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
You may not be if
\- 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
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:
* 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.
Clareo Health | 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
