Clinical trial NCT04177810: Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer
Official title: A Phase 2 Study of Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Pancreatic Cancer
Keywords: Plerixafor
Cemiplimab
Immunotherapy
PD-L1 (receptor blocking antibody)
Anti-PD-L1
CXCR4 (chemokine receptor)
Antibodies
Metastatic pancreatic cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
name: American Association for Cancer Research
name: National Cancer Institute (NCI)
First posted: 2019-11-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective Response Rate (ORR) Using Immune RECIST (iRECIST) Criteria
timeFrame: 10 months
Secondary outcomes:
measure: Overall Response Rate (ORR) Using RECIST 1.1 Criteria
timeFrame: 10 months
measure: Number of Participants Experiencing Grade 3 or Above Drug-related Toxicities
timeFrame: 13 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center
state: Maryland
Study officials:
affiliation: Johns Hopkins Medical Institution
name: Dung Le, MD
role: PRINCIPAL_INVESTIGATOR
References: