Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer

A Phase 2 Study of 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.

Study Overview

• Status: Completed
• Conditions: Metastatic Pancreatic Cancer
• Intervention / Treatment: Drug: Cemiplimab; Drug: Plerixafor

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Sidney Kimmel Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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.; Other Names: REGN-2810, LIBTAYO; 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.; Other Names: AMD3100, MOZOBIL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: National Cancer Institute (NCI); Genzyme, a Sanofi Company; American Association for Cancer Research
• Investigators: Principal Investigator: Dung Le, MD, Johns Hopkins Medical Institution

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Actual): March 29, 2023
• Study Completion (Actual): May 19, 2023

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Immunotherapy; Anti-PD-L1; Metastatic pancreatic cancer; Antibodies; PD-L1 (receptor blocking antibody); Plerixafor; Cemiplimab; CXCR4 (chemokine receptor)
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Antineoplastic Agents; Antineoplastic Agents, Immunological; Plerixafor; Cemiplimab
• Other Study ID Numbers: J19113; IRB00225153 (Other Identifier: Johns Hopkins Medicine Institutional Review Board); 5P01CA247886 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No