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Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04177810
Recruitment Status : Not yet recruiting
First Posted : November 26, 2019
Last Update Posted : February 13, 2020
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
American Association for Cancer Research
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: Cemiplimab Drug: Plerixafor Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Plerixafor

Arm Intervention/treatment
Experimental: Cemiplimab and Plerixafor
All participants will receive Cemiplimab and Plerixafor.
Drug: Cemiplimab
  1. Patients will receive treatment Day 1 of each cycle (21 days) for up to 2 years.
  2. Drug: Cemiplimab (350 mg) will be administered IV on day 1 (21 day cycle).
Other Name: REGN-2810, Libtayo

Drug: Plerixafor
  1. Patients will receive treatment on the first 7 days of each cycle (21 days) for up to 2 years.
  2. Drug: Plerixafor (80mcg/kg/hr) will be administered as a continuous IV infusion of the first 7 days of each cycle (21 days cycle).
Other Name: AMD3100, Mozobil




Primary Outcome Measures :
  1. Objective response rate (ORR) using immune RECIST (iRECIST) criteria [ Time Frame: 4 years ]
    ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) 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. Estimation based on the Kaplan-Meier curve.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) using RECIST 1.1 criteria [ Time Frame: 4 years ]
    Overall Response Rate (ORR) is the best response recorded from the start of the study treatment until the disease progression/recurrence based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Estimation based on the Kaplan-Meier curve.

  2. Number of participants experiencing grade 3 or above drug-related toxicities [ Time Frame: 4 years ]
    When calculating the incidence of adverse events (AEs), each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject. Estimation based on the Kaplan-Meier curve.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04177810


Contacts
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Contact: Susan Sartorius-Mergenthaler, RN 410-614-3644 Sartosu@jhmi.edu
Contact: Ellen Lilly-Forman, RN 443-287-4961 lillyel@jhmi.edu

Locations
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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Genzyme, a Sanofi Company
American Association for Cancer Research
Investigators
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Principal Investigator: Dung Le, MD Johns Hopkins Medical Institution

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT04177810    
Other Study ID Numbers: J19113
IRB00225153 ( Other Identifier: Johns Hopkins Medicine Institutional Review Board )
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Plerixafor
Cemiplimab
Immunotherapy
PD-L1 (receptor blocking antibody)
Anti-PD-L1
CXCR4 (chemokine receptor)
Antibodies
Metastatic pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Plerixafor octahydrochloride
Cemiplimab
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Immunological
Antineoplastic Agents