Radiation Therapy in Combination With Durvalumab for People With Pancreatic Cancer

Patients with histopathologic or cytologic diagnosis of adenocarcinoma of the pancreas (PDAC), or suspicious for malignancy per pathology, which is deemed BR or LA PDAC per NCCN guidelines or following evaluation by a Multidisciplinary group of physicians.Patients must have received FOLFIRINOX for 3-6 months prior to enrollment with at least stable disease by restaging imaging.

Note: SOC treatment regimen derived from FOLFIRINOX dose modifications are acceptable.

To maximize potential efficacy no more than a 6-week treatment break is recommended between the completion of SOC chemotherapy (FOLFIRINOX) and initiation of study treatment (durvalumab).

Age ≥ 18 yearsBody weight >30kg ECOG 0-2

Patients must have normal organ and marrow function as defined below:

Absolute Neutrophil Count (ANC) ≥1.0 K/mcLPlatelets ≥75 K/mcL Hemoglobin ≥ 9 g/dL Total bilirubin ≤ 1.5 X upper limit of normal (ULN) AST(SGOT) and ALT(SGPT) ≤ 2.5 X ULN Creatinine OR creatinine clearance ≤ 1.5 times the upper limit of normal OR > 40 mL/min for patients with creatinine levels above normal.

Note: Patients with biliary stent are eligible provided that all other inclusion criteria are met.

Negative pregnancy test in women of childbearing potential (WOCBP) within 30 days of durvalumab administration or evidence of post-menopausal status. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).Non-sterilized male participants who are sexually active with a female partner of childbearing potential must be willing to use a highly effective method of contraception from Day 1 through 90 days after receipt of the final dose of investigational product(s). Not engaging in sexual activity for the total duration of the study and the drug washout period is an acceptable practice; however, occasional abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Male participants must be willing to refrain from sperm donation throughout these periods. Ability to understand and the willingness to sign an informed consent document. Willingness and ability to comply with the protocol including study treatment, scheduled assessments and follow-up.