Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Aug 1, 2023
  • participants needed
    21
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 6 April 2022

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.

Details
Condition Metastatic Pancreatic Cancer
Treatment Plerixafor, Cemiplimab
Clinical Study IdentifierNCT04177810
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on6 April 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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