plerixafor and cemiplimab in metastatic pancreatic cancer

Conditions: Metastatic Pancreatic Cancer

Summary: 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.


Eligibility criteria:
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.

Keywords: plerixafor cemiplimab immunotherapy pd-l1 (receptor blocking antibody) anti-pd-l1 cxcr4 (chemokine receptor) antibodies metastatic pancreatic cancer