Recruiting

Radiation Therapy in Combination With Durvalumab for People With Pancreatic Cancer

# NCT03245541 Trial phase: 1, 2 Study type: local, immunotherapy

Study Start Date

August, 2020

Scientific Title

A Phase I/II Study of Durvalumab (Medi 4736) and Stereotactic Ablative Body Radiotherapy in Locally Advanced Pancreatic Adenocarcinoma

Summary

The purpose of this study is to find out if combining durvalumab with standard stereotactic ablative radiotherapy (SABR) is an effective treatment for people with locally advanced or borderline resectable pancreatic cancer. The researchers will also look at the safety of the combination treatment and any side effects it causes.

- Patients with histopathological or cytological diagnosis of adenocarcinoma of the pancreas, or suspicious for malignancy per pathology, which is deemed BR or LAPC per NCCN guidelines or following evaluation by a Multidisciplinary group of physicians. - Patients must have received FOLFIRINOX for up to 6 months prior to enrollment with at least stable disease by restaging imaging. Note: SOC treatment regimen derived from FOLFIRINOX dose modifications is 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 years - Body weight >30kg - ECOG 0-2 - Patients must have normal organ and marrow function as defined below: - Absolute Neutrophil Count (ANC) ≥1.0 K/mcL - Platelets ≥100 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 subjects 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 subjects 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.

Study Design

Primary purpose: Treatment , Allocation: N/A , Intervention model: Single Group Assignment , Masking: None (Open Label)

Conditions

Pancreatic Adenocarcinoma

Locations

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