Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: American Association for Cancer Research; Genzyme, a Sanofi Company
• Treatments: Antibodies; Cemiplimab; Plerixafor; Plerixafor octahydrochloride

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.