Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer

Inclusion criteria

Age ≥18 years.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Have histologically or cytologically-proven ductal pancreatic cancer.
• Have metastatic disease.
• Have documented radiographic disease progression after previous systemic chemotherapy given in a neoadjuvant, adjuvant, locally advanced or metastatic setting.
• Patients with the presence of at least one measurable lesion.
• Willing to have to a tumor biopsy.
• Life expectancy of greater than 3 months.
• Patients must have adequate organ and marrow function defined by study - specified laboratory tests.
• Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.
• Men must use acceptable form of birth control while on study.
• Ability to understand and willingness to sign a written informed consent document.

Exclusion criteria

• Known history or evidence of brain metastases.
• Had chemotherapy, radiation, or steroids within 14 days prior to study treatment.
• Have received any investigational drugs, a live vaccine, any allergen hyposensitization therapy, growth factors or major surgery within 28 days prior to study treatment.
• Require any antineoplastic therapy.
• Had surgery within 28 days of dosing of investigational agent.
• Has received any prophylactic vaccine within 14 days of first dose of study drug.
• History of prior treatment with anti-CXCR4.
• Have used any systemic steroids within 14 days of study treatment.
• Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), Granulocyte-macrophage colony-stimulating factor (GM-CSF), erythropoietin, within 14 days of study drug administration.
• Hypersensitivity reaction to any monoclonal antibody.
• Evidence of clinical or radiographic ascites.
• Have clinically significant and/or malignant pleural effusion.
• Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Has an active known or suspected autoimmune disease.
• Prior tissue or organ allograft or allogeneic bone marrow transplantation.
• All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 5) or baseline before administration of study drug.
• Infection with HIV or hepatitis B or C at screening.
• Patient has a pulse oximetry of <92% on room air.
• Patient is on supplemental home oxygen.
• Has uncontrolled intercurrent acute or chronic medical illness or any use of illicit drugs or substance abuse.
• Patient is unwilling or unable to follow the study schedule for any reason.
• Woman who are pregnant or breastfeeding.
• Have rapidly progressing disease, as judged by the investigator.
• History of significant, recurrent, unexplained postural hypotension in the last 6 months.