Last reviewed · How we verify

NCT03092453

Dendritic Cell Vaccination in Patients With Advanced Melanoma

Completed Phase 1 Results posted Last updated 24 December 2024
What this trial tests

Phase 1 trial testing Mature dendritic cell (DC) vaccine in Melanoma in 5 participants. Completed in 31 March 2023.

Timeline
1 May 2017
Primary endpoint
31 March 2023
31 March 2023

Quick facts

Lead sponsorUniversity of Pennsylvania
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment5
Start date1 May 2017
Primary completion31 March 2023
Estimated completion31 March 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Pennsylvania

Who can join

18 and older, any sex, with Melanoma. 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.

Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay. Primary · Screening through week 21

Immune response measuring increased numbers of peptide specific T cells as calculated by the tetramer assay. The numbers of Peptide Specific T Cells are reported as the percent of CD8+ T cells that were p/HLA multimer positive for each antigen.

Antigen A3-1, screening
GroupValue95% CI
Subject 10
Subject 30
Subject 40
Antigen A3-2, screening
GroupValue95% CI
Subject 10
Subject 30
Subject 40
Antigen A3-3, screening
GroupValue95% CI
Subject 10
Subject 30
Subject 40
Antigen A3-4, screening
GroupValue95% CI
Subject 10
Subject 30
Subject 40
Antigen A3-5, screening
GroupValue95% CI
Subject 10
Subject 30
Subject 40
Antigen A3-6, screening
GroupValue95% CI
Subject 10
Subject 30
Subject 40
Antigen A3-7, screening
GroupValue95% CI
Subject 10
Subject 30
Antigen B8-1, screening
GroupValue95% CI
Subject 10
Safety and Tolerability of the Mature Dendritic Cell Vaccine (mDC3/8 Vaccines). Primary · End of Study visit (10-28 days after last DC vaccine)

Safety endpoint is type and number of adverse events. Tolerability endpoint is subject's completion or withdrawal from study treatment.

GroupValue95% CI
Mature Dendritic Cell (DC) Vaccine3
Mature Dendritic Cell (DC) Vaccine2
Clinical Response to the mDC3/8 Vaccine(s) Secondary · At the End of Study Treatment visit (~10-28 Days after the last DC vaccine)

using RECIST 1.1

GroupValue95% CI
Mature Dendritic Cell (DC) Vaccine2
Mature Dendritic Cell (DC) Vaccine3
Time to Progression Post-mDC3/8 Vaccine Administration Secondary · Up to 30 weeks after the first mDC3/8 Vaccine

based on RECIST 1.1 criteria, until occurrence of a censoring event

Subject 1
GroupValue95% CI
Mature Dendritic Cell (DC) Vaccine113
Subject 2
GroupValue95% CI
Mature Dendritic Cell (DC) VaccineNA
Subject 3
GroupValue95% CI
Mature Dendritic Cell (DC) VaccineNA
Subject 4
GroupValue95% CI
Mature Dendritic Cell (DC) VaccineNA
Subject 5
GroupValue95% CI
Mature Dendritic Cell (DC) Vaccine80
Safety and Side Effect Profile of the Dendritic Cell Vaccine (mDC3/8 Vaccines) Administered to Patients Given After a Single Dose of Cyclophosphamide. Secondary · End of Study visit (10-28 days after last DC vaccine)

Assessed through collection of Adverse Events.

GroupValue95% CI
Mature Dendritic Cell (DC) Vaccine5

Adverse events — posted to ClinicalTrials.gov

Time frame: Collection of AEs will begin at the time of the first apheresis procedure (Apheresis #1) and continue until subject discontinuation or the End of Study Visit. (week 30).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mature Dendritic Cell (DC) Vaccine
Serious: 1/5 (20%)
Deaths: 0/5

Serious adverse events (2 terms)

ReactionSystemMature Dendritic Cell (DC)…
Tumor painNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Surgical and medical procedures - Other (Palliative mass resection)Surgical and medical procedures
Other adverse events (12 terms — click to expand)

ReactionSystemMature Dendritic Cell (DC)…
NauseaGastrointestinal disorders
ChillsGeneral disorders
FatigueGeneral disorders
HeadacheNervous system disorders
Cardiac disorders - other )tachycardia)Cardiac disorders
Abdominal PainGastrointestinal disorders
ConstipationGastrointestinal disorders
Dental CariesGastrointestinal disorders
ToothacheGastrointestinal disorders
Flu like symptomsGeneral disorders
ParethesiaNervous system disorders
CoughRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Tumor pain, Surgical and medical procedures - Other (Palliative mass resection).

Data from ClinicalTrials.gov NCT03092453 adverse events section.

Sponsor's own description

The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.

Publications & conference data

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

  1. Research progress on dendritic cell vaccines in cancer immunotherapy.
    Yu J, Sun H, Cao W, Song Y, et al · · 2022 · cited 130× · PMID 35074008 · DOI 10.1186/s40164-022-00257-2
  2. Neoantigen prediction and computational perspectives towards clinical benefit: recommendations from the ESMO Precision Medicine Working Group.
    De Mattos-Arruda L, Vazquez M, Finotello F, Lepore R, et al · · 2020 · cited 126× · PMID 32610166 · DOI 10.1016/j.annonc.2020.05.008
  3. Trial watch: dendritic cell vaccination for cancer immunotherapy.
    Sprooten J, Ceusters J, Coosemans A, Agostinis P, et al · · 2019 · cited 107× · PMID 31646087 · DOI 10.1080/2162402x.2019.1638212
  4. Dendritic Cell Cancer Therapy: Vaccinating the Right Patient at the Right Time.
    van Willigen WW, Bloemendal M, Gerritsen WR, Schreibelt G, et al · · 2018 · cited 102× · PMID 30327656 · DOI 10.3389/fimmu.2018.02265
  5. Towards superior dendritic-cell vaccines for cancer therapy.
    Saxena M, Balan S, Roudko V, Bhardwaj N. · · 2018 · cited 99× · PMID 30116654 · DOI 10.1038/s41551-018-0250-x
  6. Immunotherapy Based on Dendritic Cell-Targeted/-Derived Extracellular Vesicles-A Novel Strategy for Enhancement of the Anti-tumor Immune Response.
    Markov O, Oshchepkova A, Mironova N. · · 2019 · cited 96× · PMID 31680949 · DOI 10.3389/fphar.2019.01152
  7. Dendritic Cells and Programmed Death-1 Blockade: A Joint Venture to Combat Cancer.
    Versteven M, Van den Bergh JMJ, Marcq E, Smits ELJ, et al · · 2018 · cited 75× · PMID 29599770 · DOI 10.3389/fimmu.2018.00394
  8. Impaired function of dendritic cells within the tumor microenvironment.
    Xiao Z, Wang R, Wang X, Yang H, et al · · 2023 · cited 61× · PMID 37441069 · DOI 10.3389/fimmu.2023.1213629

Verify or expand the search:

Other recruiting trials for Melanoma

Currently open trials in the same condition.

Other University of Pennsylvania trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03092453.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing