ALDESLEUKIN for Pancreatic cancer

Inclusion criteria

• {"criterion_text":"- 1.\tPatients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution."}
• {"criterion_text":"- 2.\tPatient is a male or female age >18"}
• {"criterion_text":"- 3.\tBy the surgeons evaluation fit for pancreatic surgery"}
• {"criterion_text":"- 4.\tSubjects must have radiologic, and/or cytologic confirmation of primary resectable pancreatic or periampullary cancer. Pancreatic ductal adenocarcinoma, ampullary carcinoma and cholangiocarcinoma are the most common forms, but also other rare forms of pancreatic and periampullary cancer may be included."}

Exclusion criteria

• {"criterion_text":"- 1.\tClass III or IV cardiac disease, hypotension or severe hypertension, vasomotor instability, serious or uncontrolled cardiac dysrhythmias (including ventricular arrhythmias) at any time, acute myocardial infarction within the past 6 months, active uncontrolled angina pectoris or symptomatic arteriosclerotic blood vessel disease."}
• {"criterion_text":"- 2.\tHistory of uncontrolled seizures, severe central nervous system disorders, or psychiatric disability thought to be clinically significant in the opinion of the Investigator and adversely affecting compliance to protocol."}
• {"criterion_text":"- 3.\tOngoing treatment with immunomodulating medication, i.e. corticosteroids."}
• {"criterion_text":"- 4.\tOngoing active peptic ulcer."}
• {"criterion_text":"- 5.\tOngoing asthma."}
• {"criterion_text":"- 6.\tAny other condition or symptoms preventing the patient from entering the study, according to the PI's judgement."}
• {"criterion_text":"- 7.\tA woman of childbearing potential (WOCBP) must agree to comply with using an effective contraceptive method for the duration of the treatment (a WOCBP is a sexually mature woman who is not surgically sterile or has not been naturally postmenopausal for at least 12 consecutive months). Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < 1% when used consistently and correctly. Local laws and regulations may require use of alternative and/or additional contraception methods. One of the highly effective methods of contraception listed below is required during study duration and until the end of relevant systemic exposure, defined as 5 months after the end of study treatment."}

Primary endpoints

• {"endpoint_text":"- The safety and tolerability of the treatment will be evaluated by the assessment of all adverse events (AEs) occurring during treatment—both those considered treatment-related and unrelated. Adverse events will be collected from Cycle 1 Day 1 through the final study visit and will be graded for severity according to the NCI-CTCAE, version 5.0. Safety will also be evaluated by clinical laboratory tests, physica","definition_or_measurement_approach":"Adverse events collected from Cycle 1 Day 1 through final study visit and graded for severity according to NCI-CTCAE v5.0; safety also evaluated by clinical laboratory tests (text truncated in source)."}

Secondary endpoints

• {"endpoint_text":"- Secondary Efficacy Variables: Progression-free survival and overall survival","definition_or_measurement_approach":"Progression-free survival and overall survival are listed as efficacy variables; no further measurement definitions provided in the source."}
• {"endpoint_text":"- Secondary Outcome Biomarker Variables: •\tNK cell subsets in blood, including immature (CD16-) and cytotoxic (CD16+) subsets, activation markers, natural cytotoxicity receptors including NKp30, NKp46 and NKG2D, killer-immunoglobulin receptors. •\tT cell subsets including CD4+/25 regulatory T cells and naive, central memory, effector memory and effector CD8+ T cells","definition_or_measurement_approach":"Lists biomarker measurements to include NK cell subsets and T cell subsets in blood; no specific assay methods or timepoints provided in the source."}
• {"endpoint_text":"- continuation Secondary Outcome: Biomarker Variables: •\tMyeloid cell populations including granulocytes and monocytes, MDSC, dendritic cells, activation markers, PD-L1, PD-L2 and related immune biomarkers. •\tSerum CA 19-9 •\tSerum levels of cytokines, chemokines and other soluble mediators of inflammation •\tAmount of tumor-infiltrating lymphocytes (TILs) and tumor-infiltrating myeloid cells","definition_or_measurement_approach":"Lists additional biomarker variables including myeloid populations, serum CA 19-9, cytokines/chemokines, and tumor-infiltrating immune cells; no specific measurement methods provided in the source."}

Sweden

Earliest CTIS Part Ii Submission Date

29-04-2024

Latest Decision Or Authorization Date

17-05-2024

Processing Time Days

18

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Vaestra Goetalandsregionen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden