NIVOLUMAB for Pancreatic cancer | Borderline resectable pancreatic cancer | Locally advanced pancreatic cancer | Metastatic pancreatic cancer

Inclusion criteria

• {"criterion_text":"- Signed informed consent o Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care o Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study\n- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. The investigator shall review contraception methods and the time period that contraception must be followed. Men that are sexually active with WOCBP must follow instructions for birth control when the half-life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 90 days plus the time required for the investigational drug to undergo five half-lives. Men who are sexually active with WOCBP must continue contraception for 31 weeks (90 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception\n- Subjects must have signed and dated a BIOPAC approved written informed consent form in accordance with regulatory and institutional guidelines\n- Histological or cytological confirmation of BRPC, LAPC or mPC prior to entering this study\n- No prior chemotherapy regimens received for PC\n- Age 18 years or older\n- Life expectancy greater than 6 months\n- ECOG/WHO Performance Status (PS) 0-1\n- All participants will be required to undergo mandatory pre- and on-treatment biopsies at acceptable clinical risk as judged by the investigator. An archival pre-treatment sample is acceptable\n- Patients must have normal organ and marrow function as defined below: o Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L o Platelet count ≥ 100 x 10⁹/L o Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (patients with Gilbert's Syndrome must have a total bilirubin ≤ 50 mmol/L) o Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤ 5 x ULN o Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (using the Cockcroft-Gault formula)\n- Women of childbearing potential (WOCBP) must use method(s) of contraception as indicated in Appendix 3. For a teratogenic study drug and/or when there is insufficient information to assess teratogenicity (preclinical studies have not beendone), a highly effective method(s) of contraception (failure rate of less than 1% per year) is required. The individual methods of contraception and duration should be determined in consultation with the investigator. WOCBP must follow instructions for birth control when the half-life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 30 days plus the time required for the investigational drug to undergo five half-lives. The half-life of nivolumab and ipilimumab is up to 25 days and 18 days, respectively. WOCBP should therefore use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug"}

Exclusion criteria

• {"criterion_text":"- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways\n- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results\n- Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n- Participants with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n- Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\n- Allergies and Adverse Drug Reaction o History of allergy to study drug components o History of severe hypersensitivity reaction to any monoclonal antibody\n- WOCBP who are pregnant or breastfeeding"}

Primary endpoints

• {"endpoint_text":"- Incidence of treatment-related AEs, SAEs, AEs leading to discontinuation, death, and laboratory abnormalities","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Median PFS using RECIST v1.1 and PFSR at 6, 9, and 12 months","definition_or_measurement_approach":"Progression-free survival measured by RECIST v1.1; PFS rate measured at specified timepoints (6, 9, 12 months)"}
• {"endpoint_text":"- Median OS and OSR at 6 months, 1 year, and 2 years","definition_or_measurement_approach":"Overall survival (OS) and OS rate at specified timepoints"}
• {"endpoint_text":"- Objective Response Rate (ORR) and median duration of response (DOR) by RECIST v1.1","definition_or_measurement_approach":"ORR and DOR assessed by RECIST v1.1"}
• {"endpoint_text":"- Rate of downstaging to surgical resection","definition_or_measurement_approach":""}

Denmark

Earliest CTIS Part Ii Submission Date

27-09-2024

Latest Decision Or Authorization Date

08-10-2024

Processing Time Days

11

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Region Hovedstaden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"","full_name":"Danish Cancer Society","duties_or_roles":"Monetary support","organisation_type":""}