The purpose of this study is to evaluate the safety and clinical activity of plerixafor in
combination with cemiplimab in patients with metastatic pancreatic cancer.
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
- 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.
- 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
- 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
- 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