Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer

NCT ID: NCT04177810

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-16
• Study Completion Date: 2023-05-19

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.

Conditions

Metastatic Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cemiplimab and Plerixafor

All participants will receive Cemiplimab and Plerixafor.

Group Type: EXPERIMENTAL

Cemiplimab

Intervention Type: DRUG

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

Plerixafor

Intervention Type: DRUG

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.

Interventions

Cemiplimab

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

REGN-2810, LIBTAYO; AMD3100, MOZOBIL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

American Association for Cancer Research

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dung Le, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Medical Institution

Locations

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00225153

Identifier Type: OTHER

Identifier Source: secondary_id

5P01CA247886

Identifier Type: NIH

Identifier Source: secondary_id

View Link

J19113

Identifier Type: -

Identifier Source: org_study_id