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Checkpoint Inhibitor
Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer
Phase 2
Waitlist Available
Led By Dung Le, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a combination of two drugs, plerixafor and cemiplimab, in patients with advanced pancreatic cancer. Plerixafor helps move cells into the bloodstream, and cemiplimab helps the immune system attack cancer. The goal is to see if this combination is safe and effective for these patients. Plerixafor has been studied for its safety and effectiveness in patients with nonhematologic diseases.
Eligible Conditions
- Pancreatic Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate (ORR) Using Immune RECIST (iRECIST) Criteria
Secondary study objectives
Number of Participants Experiencing Grade 3 or Above Drug-related Toxicities
Overall Response Rate (ORR) Using RECIST 1.1 Criteria
Side effects data
From 2021 Phase 2 & 3 trial • 20 Patients • NCT0223187937%
Bone pain
32%
Upper Respiratory Tract Infection
26%
Weight gain
16%
Blood alkaline phosphatase increased
16%
Upper respiratory infection
16%
Injection Site Reaction
16%
Hyperuricemia
16%
Hypocalcemia
16%
Headache
16%
Rash
11%
Tooth extraction
11%
Pharyngitis
11%
Abscess
11%
Herpes simplex
11%
Urinary Tract Infection
11%
Tinea corporis
11%
Fracture
11%
Migraine
11%
Acute bronchitis
11%
Elective surgery
11%
Acute sinusitis
11%
Alanine aminotransferase increased
11%
Creatinine increased
11%
Knee pain
11%
Arthralgia
11%
Papular rash
11%
Pruritic rash
5%
Skin Infection
5%
Cellulitis
5%
Iron Deficiency Anemia
5%
Arthritis
5%
Nausea
5%
Tinea capitis
5%
Aspartate aminotransferase increased
5%
Anemia
5%
Tinnitus
5%
Diarrhea
5%
Infectious Diarrhea
5%
Otitis media
5%
Bone mineral content decreased
5%
Hyperglycemia
5%
Hypernatremia
5%
Hyperkalemia
5%
Joint pain
5%
Low back pain
5%
Ovarian cyst
100%
80%
60%
40%
20%
0%
Study treatment Arm
Plerixafor
G-CSF
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cemiplimab and PlerixaforExperimental Treatment2 Interventions
All participants will receive Cemiplimab and Plerixafor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Plerixafor
2011
Completed Phase 3
~710
Cemiplimab
2015
Completed Phase 3
~1470
Find a Location
Who is running the clinical trial?
Genzyme, a Sanofi CompanyIndustry Sponsor
527 Previous Clinical Trials
185,711 Total Patients Enrolled
American Association for Cancer ResearchOTHER
8 Previous Clinical Trials
807 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,145 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
571 Previous Clinical Trials
33,306 Total Patients Enrolled
Dung Le, MDPrincipal InvestigatorJohns Hopkins Medical Institution
12 Previous Clinical Trials
609 Total Patients Enrolled