- Age ≥18 years.
- Patients with histologically- or cytologically-proven, surgically unresectable,
locally advanced pancreatic adenocarcinoma.
- If the patient does not have a diagnostic biopsy that is adequate for review at our
institution, the patient must agree to a research core biopsy to be performed at Johns
- If the patient's available imaging is not adequate for review by our institution, the
patient must agree to a repeat imaging to be performed at Johns Hopkins.
- Patients cannot have had any prior therapy for the locally advanced pancreatic
- ECOG performance status 0 or 1
- Life expectancy greater than 3 months.
- Able to swallow pills or capsules.
- Patient must have adequate organ function defined by the study-specified laboratory
- Patients must be eligible to receive FOLFIRINOX-based chemotherapy.
- Patients must be willing to be treated with stereotactic body radiation therapy (SBRT)
only at Johns Hopkins Hospital.
- Patients must be willing to undergo a core biopsy of the pancreatic cancer.
- Patients must be willing to undergo a biopsy of the pancreatic cancer if the patient
is not deemed a surgical candidate during the pre-surgical evaluation.
- Must use acceptable form of birth control while on study.
- Ability to understand and willingness to sign a written informed consent document.
- Have had non-FOLFIRINOX-based chemotherapy for the pancreatic cancer.
- Have received any anti-neoplastic biologics, vaccines or hormonal treatment, including
investigational drugs, within 28 days of the first dose of study.
- History of past treatment with immunotherapy agents prior to initial enrollment into
this study (including, but not limited to: IL-2, interferon, anti-PD-1, anti-PD-L1,
anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, anti-CTLA-4 or anti-CCR2/5 drugs).
- Have had prior organ or tissue allograft or allogeneic bone marrow transplantation,
including corneal transplants.
- Is currently participating or has participated in a study of an investigational agent
or using an investigational device for the treatment of cancer.
- Current use of immunosuppressive medications within 14 days prior to study
- Have received any vaccine within 14 days prior to study medications.
- Receiving growth factors including, but not limited to, granulocyte-colony stimulating
factor (G-CSF), GM-CSF, erythropoietin, within 14 days of the first dose of study
- History of any autoimmune disease. Patients with thyroid disease will be allowed.
- Has a history of (non-infectious) pneumonitis or current pneumonitis.
- Has a pulse oximetry < 92% on room air.
- Requires the use of home oxygen.
- Patients with uncontrolled intercurrent illness including, but not limited to,
myocardial infarction or stroke/transient ischemic attack within the past 6 months,
uncontrolled infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements.
- 12-lead electrocardiogram with QRS ≥ 120 msec, except right bundle branch block ; QTcF
(QT corrected for heart rate using Fridericia's method) ≥ 480 msec, except right
bundle branch block
- Has an active infection requiring systemic therapy.
- Infection with HIV or hepatitis B or C.
- Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder
cancer, early stage prostate cancer, or carcinoma in situ of the cervix.
- Current or recent (within 3 months of study treatment administration) gastrointestinal
disease that could impact the absorption of study treatment.
- Any gastrointestinal surgery that is likely impact upon the absorption of study
- Inability to tolerate oral medication.
- Unable to have blood drawn.
- Have had surgery within 28 days of the first dose of study medication.
- Prior use of strong/moderate CYP3A4 inhibitors or inducers within 28 days of the first
dose of BMS-813160.
- Prior use of Class I antiarrhythmics within 28 days of first dose of study medication.
- Has ascites requiring medical management.
- Presence of duodenal or gastric invasion by the tumor.
- Hypersensitivity reaction to any monoclonal antibody.
- Known allergy or hypersensitivity to study drugs or any of their components of the
study arm that participant is enrolling.
- Woman who are pregnant or breastfeeding.
- Patient is unwilling or unable to follow the study schedule for any reason.