Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer

NCT04177810 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: J19113IRB002251535P01CA247886
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

Plerixafor; Cemiplimab; Immunotherapy; PD-L1 (receptor blocking antibody); Anti-PD-L1; CXCR4 (chemokine receptor); Antibodies; Metastatic pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Response Rate (ORR) Using RECIST 1.1 Criteria

  10 months

• Number of Participants Experiencing Grade 3 or Above Drug-related Toxicities

  13 months

Study Arms (1)

Cemiplimab and Plerixafor

EXPERIMENTAL

All participants will receive Cemiplimab and Plerixafor.

Drug: Cemiplimab; Drug: Plerixafor

Interventions

Cemiplimab DRUG

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

Also known as: REGN-2810, LIBTAYO

Cemiplimab and Plerixafor

Plerixafor 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.

Also known as: AMD3100, MOZOBIL

Cemiplimab and Plerixafor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Genzyme, a Sanofi Company: collaborator
• American Association for Cancer Research: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

cemiplimab; plerixafor

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dung Le, MD
• Organization: SKCCC Johns Hopkins Medical Institution

Dle@jhmi.edu

443-287-0002

Study Officials

• Dung Le, MD

  Johns Hopkins Medical Institution

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 26, 2019
• Study Start: November 16, 2020
• Primary Completion: March 29, 2023
• Study Completion: May 19, 2023
• Last Updated: February 23, 2024
• Results First Posted: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)