Plerixafor And Cemiplimab In Metastatic Pancreatic Cancer

Study Overview

Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer

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.

N/A

Metastatic Pancreatic Cancer

DRUG: Cemiplimab
DRUG: Plerixafor

J19113
IRB00225153 (OTHER Identifier) (OTHER: Johns Hopkins Medicine Institutional Review Board)
5P01CA247886 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-11-22	Results First Submitted 2024-01-26	Last Update Submitted that met QC Criteria 2024-02-21
First Submitted that Met QC Criteria 2019-11-22	Results First Submitted that Met QC Criteria 2024-01-26	Last Update Posted (ACTUAL) 2024-02-23
First Posted (ACTUAL) 2019-11-26	Results First Posted 2024-02-20	Last Verified 2024-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Cemiplimab and Plerixafor All participants will receive Cemiplimab and Plerixafor.	DRUG: Cemiplimab Cemiplimab (350 mg) will be administered IV on day 1 of each cycle (21 day cycle) for up to 2 years. DRUG: Plerixafor Plerixafor (80mcg/kg/hr) will be administered as a continuous IV infusion of the first 7 days of each cycle (21 day cycle) for up to 2 years.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Cemiplimab and Plerixafor

All participants will receive Cemiplimab and Plerixafor.

DRUG: Cemiplimab

Cemiplimab (350 mg) will be administered IV on day 1 of each cycle (21 day cycle) for up to 2 years.

DRUG: Plerixafor

Plerixafor (80mcg/kg/hr) will be administered as a continuous IV infusion of the first 7 days of each cycle (21 day cycle) for up to 2 years.

Primary Outcome Measures	Measure Description	Time Frame
Objective Response Rate (ORR) Using Immune RECIST (iRECIST) Criteria	ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on immune Response Evaluation Criteria in Solid Tumors (iRECIST) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.	10 months

Secondary Outcome Measures	Measure Description	Time Frame
Overall Response Rate (ORR) Using RECIST 1.1 Criteria	Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions. Subjects who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders.	10 months
Number of Participants Experiencing Grade 3 or Above Drug-related Toxicities	Defined using NCI CTCAE v5.0	13 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Genzyme, a Sanofi Company
American Association for Cancer Research
National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Dung Le, MD, Johns Hopkins Medical Institution

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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