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NCT04177810

Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer

Completed Phase 2 Results posted Last updated 23 February 2024
What this trial tests

Phase 2 trial testing Cemiplimab in Metastatic Pancreatic Cancer in 25 participants. Completed in 19 May 2023.

Timeline
16 November 2020
Primary endpoint
29 March 2023
19 May 2023

Quick facts

Lead sponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment25
Start date16 November 2020
Primary completion29 March 2023
Estimated completion19 May 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

18 and older, any sex, with Metastatic Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Objective Response Rate (ORR) Using Immune RECIST (iRECIST) Criteria Primary · 10 months

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.

GroupValue95% CI
Cemiplimab and Plerixafor0
Overall Response Rate (ORR) Using RECIST 1.1 Criteria Secondary · 10 months

Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. Subjects who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders.

GroupValue95% CI
Cemiplimab and Plerixafor0
Number of Participants Experiencing Grade 3 or Above Drug-related Toxicities Secondary · 13 months

Defined using NCI CTCAE v5.0

GroupValue95% CI
Cemiplimab and Plerixafor4

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 17 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cemiplimab and Plerixafor
Serious: 13/21 (62%)
Deaths: 21/21

Serious adverse events (14 terms)

ReactionSystemCemiplimab and Plerixafor
Disease ProgressionGeneral disorders
Abdominal painGastrointestinal disorders
FeverGeneral disorders
Bile Duct StenosisHepatobiliary disorders
ConfusionPsychiatric disorders
DeleriumPsychiatric disorders
Immune-Mediated HepatitisHepatobiliary disorders
Lactic AcidosisGeneral disorders
Lower Gastrointestinal HemorrhageGastrointestinal disorders
PericarditisCardiac disorders
Pleural EffusionRespiratory, thoracic and mediastinal disorders
PneumothoraxRespiratory, thoracic and mediastinal disorders
SepsisInfections and infestations
StrokeNervous system disorders
Other adverse events (80 terms — click to expand)

ReactionSystemCemiplimab and Plerixafor
HyperhidrosisSkin and subcutaneous tissue disorders
ParesthesiaNervous system disorders
AnemiaBlood and lymphatic system disorders
DiarrheaGastrointestinal disorders
FeverGeneral disorders
HeadacheNervous system disorders
Alkaline Phosphatase IncreasedInvestigations
DizzinessNervous system disorders
Sinus TachycardiaCardiac disorders
Abdominal PainGastrointestinal disorders
NauseaGastrointestinal disorders
Weight LossInvestigations
Alanine Aminotransferase IncreasedInvestigations
Aspartate Aminotransferase IncreasedInvestigations
HypertensionVascular disorders
Sinus BradycardiaCardiac disorders
AnorexiaMetabolism and nutrition disorders
Blood Bilirubin IncreasedInvestigations
BruisingInjury, poisoning and procedural complications
ConstipationGastrointestinal disorders
CoughRespiratory, thoracic and mediastinal disorders
Edema LimbsGeneral disorders
FatigueGeneral disorders
InsomniaPsychiatric disorders
Nasal CongestionRespiratory, thoracic and mediastinal disorders
PainGeneral disorders
Pleural EffusionRespiratory, thoracic and mediastinal disorders
Psychiatric disorders - Vivid dreamsPsychiatric disorders
Stomach PainGastrointestinal disorders
Thromboembolic EventVascular disorders
ArthralgiaMusculoskeletal and connective tissue disorders
ArthritisMusculoskeletal and connective tissue disorders
Back PainMusculoskeletal and connective tissue disorders
Dry MouthGastrointestinal disorders
DysesthesiaNervous system disorders
DysuriaRenal and urinary disorders
Gastrointestinal Disorders- MelenaGastrointestinal disorders
Infusion Related ReactionInjury, poisoning and procedural complications
MyalgiaMusculoskeletal and connective tissue disorders
Peripheral Sensory NeuropathyNervous system disorders

Most-reported serious reactions: Disease Progression, Abdominal pain, Fever, Bile Duct Stenosis, Confusion, Delerium, Immune-Mediated Hepatitis, Lactic Acidosis.

Data from ClinicalTrials.gov NCT04177810 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Inflammation and tumor progression: signaling pathways and targeted intervention.
    Zhao H, Wu L, Yan G, Chen Y, et al · · 2021 · cited 1932× · PMID 34248142 · DOI 10.1038/s41392-021-00658-5
  2. Tumor microenvironment as a therapeutic target in cancer.
    Xiao Y, Yu D. · · 2021 · cited 1438× · PMID 33259885 · DOI 10.1016/j.pharmthera.2020.107753
  3. The tumour microenvironment in pancreatic cancer - clinical challenges and opportunities.
    Ho WJ, Jaffee EM, Zheng L. · · 2020 · cited 963× · PMID 32398706 · DOI 10.1038/s41571-020-0363-5
  4. The chemokines CXCL8 and CXCL12: molecular and functional properties, role in disease and efforts towards pharmacological intervention.
    Cambier S, Gouwy M, Proost P. · · 2023 · cited 387× · PMID 36725964 · DOI 10.1038/s41423-023-00974-6
  5. Immunosuppressive cells in cancer: mechanisms and potential therapeutic targets.
    Tie Y, Tang F, Wei YQ, Wei XW. · · 2022 · cited 386× · PMID 35585567 · DOI 10.1186/s13045-022-01282-8
  6. Define cancer-associated fibroblasts (CAFs) in the tumor microenvironment: new opportunities in cancer immunotherapy and advances in clinical trials.
    Zhang H, Yue X, Chen Z, Liu C, et al · · 2023 · cited 317× · PMID 37784082 · DOI 10.1186/s12943-023-01860-5
  7. Targeting cytokine and chemokine signaling pathways for cancer therapy.
    Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3
  8. Signaling pathways in cancer-associated fibroblasts: recent advances and future perspectives.
    Fang Z, Meng Q, Xu J, Wang W, et al · · 2023 · cited 197× · PMID 36424360 · DOI 10.1002/cac2.12392

Verify or expand the search:

Other trials of Cemiplimab

Trials testing the same drug.

Other recruiting trials for Metastatic Pancreatic Cancer

Currently open trials in the same condition.

Other Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins trials

Trials by the same sponsor.

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