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We are analyzing https://link.springer.com/article/10.1007/s00262-020-02618-4.

Title:
A randomized controlled phase II clinical trial on mRNA electroporated autologous monocyte-derived dendritic cells (TriMixDC-MEL) as adjuvant treatment for stage III/IV melanoma patients who are disease-free following the resection of macrometastases | Cancer Immunology, Immunotherapy
Description:
Background Autologous monocyte-derived mRNA co-electroporated dendritic cells with mRNA encoding CD40 ligand (CD40L), CD70 and a constitutively activated TLR4 (caTLR4) (referred to as TriMixDC-MEL) have anti-tumor activity in advanced melanoma patients. We investigated the safety and activity of adjuvant TriMixDC-MEL in stage III/IV melanoma patients. Materials and methods Forty-one patients were randomly assigned to treatment with TriMixDC-MEL (n = 21) and standard follow-up (n = 20). “Cross-over” was allowed at the time of non-salvageable recurrence. The primary endpoint was the percentage of patients alive and disease-free at 1-year. For a subset of patients, (formalin-fixed paraffin-embedded), tumor tissue samples were available for mRNA expression profiling and PD-L1 immunohistochemical staining. Results Baseline characteristics were well balanced. One-year after randomization, 71% of patients in the study arm were alive and free of disease compared to 35% in the control arm. After a median follow-up of 53 months (range 3–67), 23 patients experienced a non-salvageable melanoma recurrence (TriMixDC-Mel arm n = 9 and control arm n = 14).The median time to non-salvageable recurrence was superior in the TriMixDC-MEL arm (median 8 months (range 1–6) vs. not reached; log-rank p 0.044). TriMixDC-MEL-related adverse events (AE) consisted of transient local skin reactions, flu-like symptoms and post-infusion chills. No grade ≥ 3 AE’s occurred. The mRNA expression profiling revealed four genes (STAT2, TPSAB1, CD9 and CSF2) as potential predictive biomarkers. Conclusion TriMixDC-MEL id/iv as adjuvant therapy is tolerable and may improve the 1-year disease-free survival rate. Combination of optimized autologous monocyte-derived DC-formulations warrants further investigation in combination with currently approved adjuvant therapy options.
Website Age:
28 years and 1 months (reg. 1997-05-29).

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🌠 Phenomenal Traffic: 5M - 10M visitors per month


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Keywords {🔍}

article, melanoma, pubmed, dendritic, patients, google, scholar, cells, mrna, adjuvant, stage, van, cas, trimixdcmel, study, contributed, draft, financial, analyses, revision, cancer, treatment, oncol, clinical, corthals, iii, autologous, therapy, clin, central, nuffel, amt, patient, statistical, interest, immunotherapy, electroporated, monocytederived, survival, med, wilgenhof, privacy, cookies, content, data, jansen, arm, access, httpsdoiorgjco, cell,

Topics {✒️}

trimixdc-mel-related adverse events pieter-jan van dam long-term clinical outcome pieter-jan van dam4 electroporated dendritic cells advisory role-bristol-myers squibb nonvaccine anti-tumor cells month download article/chapter t-regulatory cells correlate formalin-fixed paraffin-embedded t-cell stimulatory capacity broad t-cell response single-step antigen loading immune-related lncrna pairs circulating dendritic cells human dendritic cells dendritic cells loaded article cancer immunology full article pdf dendritic cell-bank honoraria-bristol-myers squibb van nuffel amt pd-l1 immunohistochemical staining dendritic cells immunotherapy article mrna expression profiling pj van dam stage iii melanoma durable tumor response resected stage iii phase ii study privacy choices/manage cookies bristol-myers squibb constitutively activated tlr4 ipilimumab adjuvant therapy adjuvant trimixdc-mel anti-tumor activity kris thielemans pretreated advanced melanoma institution received honoraria article jansen trimixdc-mel arm tumor tissue samples advanced melanoma patients melanoma patients treated phase ib study attended advisory boards immunotherapy aims post-infusion chills american joint committee

Schema {🗺️}

WebPage:
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         headline:A randomized controlled phase II clinical trial on mRNA electroporated autologous monocyte-derived dendritic cells (TriMixDC-MEL) as adjuvant treatment for stage III/IV melanoma patients who are disease-free following the resection of macrometastases
         description:Autologous monocyte-derived mRNA co-electroporated dendritic cells with mRNA encoding CD40 ligand (CD40L), CD70 and a constitutively activated TLR4 (caTLR4) (referred to as TriMixDC-MEL) have anti-tumor activity in advanced melanoma patients. We investigated the safety and activity of adjuvant TriMixDC-MEL in stage III/IV melanoma patients. Forty-one patients were randomly assigned to treatment with TriMixDC-MEL (n = 21) and standard follow-up (n = 20). “Cross-over” was allowed at the time of non-salvageable recurrence. The primary endpoint was the percentage of patients alive and disease-free at 1-year. For a subset of patients, (formalin-fixed paraffin-embedded), tumor tissue samples were available for mRNA expression profiling and PD-L1 immunohistochemical staining. Baseline characteristics were well balanced. One-year after randomization, 71% of patients in the study arm were alive and free of disease compared to 35% in the control arm. After a median follow-up of 53 months (range 3–67), 23 patients experienced a non-salvageable melanoma recurrence (TriMixDC-Mel arm n = 9 and control arm n = 14).The median time to non-salvageable recurrence was superior in the TriMixDC-MEL arm (median 8 months (range 1–6) vs. not reached; log-rank p 0.044). TriMixDC-MEL-related adverse events (AE) consisted of transient local skin reactions, flu-like symptoms and post-infusion chills. No grade ≥ 3 AE’s occurred. The mRNA expression profiling revealed four genes (STAT2, TPSAB1, CD9 and CSF2) as potential predictive biomarkers. TriMixDC-MEL id/iv as adjuvant therapy is tolerable and may improve the 1-year disease-free survival rate. Combination of optimized autologous monocyte-derived DC-formulations warrants further investigation in combination with currently approved adjuvant therapy options.
         datePublished:2020-06-26T00:00:00Z
         dateModified:2020-06-26T00:00:00Z
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            Melanoma
            Adjuvant therapy
            Dendritic vaccine
            Oncology
            Immunology
            Cancer Research
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      headline:A randomized controlled phase II clinical trial on mRNA electroporated autologous monocyte-derived dendritic cells (TriMixDC-MEL) as adjuvant treatment for stage III/IV melanoma patients who are disease-free following the resection of macrometastases
      description:Autologous monocyte-derived mRNA co-electroporated dendritic cells with mRNA encoding CD40 ligand (CD40L), CD70 and a constitutively activated TLR4 (caTLR4) (referred to as TriMixDC-MEL) have anti-tumor activity in advanced melanoma patients. We investigated the safety and activity of adjuvant TriMixDC-MEL in stage III/IV melanoma patients. Forty-one patients were randomly assigned to treatment with TriMixDC-MEL (n = 21) and standard follow-up (n = 20). “Cross-over” was allowed at the time of non-salvageable recurrence. The primary endpoint was the percentage of patients alive and disease-free at 1-year. For a subset of patients, (formalin-fixed paraffin-embedded), tumor tissue samples were available for mRNA expression profiling and PD-L1 immunohistochemical staining. Baseline characteristics were well balanced. One-year after randomization, 71% of patients in the study arm were alive and free of disease compared to 35% in the control arm. After a median follow-up of 53 months (range 3–67), 23 patients experienced a non-salvageable melanoma recurrence (TriMixDC-Mel arm n = 9 and control arm n = 14).The median time to non-salvageable recurrence was superior in the TriMixDC-MEL arm (median 8 months (range 1–6) vs. not reached; log-rank p 0.044). TriMixDC-MEL-related adverse events (AE) consisted of transient local skin reactions, flu-like symptoms and post-infusion chills. No grade ≥ 3 AE’s occurred. The mRNA expression profiling revealed four genes (STAT2, TPSAB1, CD9 and CSF2) as potential predictive biomarkers. TriMixDC-MEL id/iv as adjuvant therapy is tolerable and may improve the 1-year disease-free survival rate. Combination of optimized autologous monocyte-derived DC-formulations warrants further investigation in combination with currently approved adjuvant therapy options.
      datePublished:2020-06-26T00:00:00Z
      dateModified:2020-06-26T00:00:00Z
      pageStart:2589
      pageEnd:2598
      sameAs:https://doi.org/10.1007/s00262-020-02618-4
      keywords:
         TriMixDC-MEL
         Melanoma
         Adjuvant therapy
         Dendritic vaccine
         Oncology
         Immunology
         Cancer Research
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                     name:Department of Medical Oncology, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Brussels, Belgium
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                     type:PostalAddress
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            affiliation:
                  name:Vrije Universiteit Brussel
                  address:
                     name:Laboratory of Molecular and Cellular Therapy and Dendritic Cell-bank, Vrije Universiteit Brussel, Brussels, Belgium
                     type:PostalAddress
                  type:Organization
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                  name:Histogenex NV
                  address:
                     name:Histogenex NV, Antwerp, Belgium
                     type:PostalAddress
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            name:Pieter-Jan van Dam
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                     name:Department of Medical Oncology, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Brussels, Belgium
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                     type:PostalAddress
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            affiliation:
                  name:Universitair Ziekenhuis Gent (UZ Gent)
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                     name:Department of Medical Oncology, Universitair Ziekenhuis Gent (UZ Gent), Ghent, Belgium
                     type:PostalAddress
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               name:Laboratory of Molecular and Cellular Therapy and Dendritic Cell-bank, Vrije Universiteit Brussel, Brussels, Belgium
               type:PostalAddress
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      name:Kelly Schats
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               name:Histogenex NV, Antwerp, Belgium
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               name:Department of Medical Oncology, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Brussels, Belgium
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            name:Vrije Universiteit Brussel
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               name:Laboratory of Molecular and Cellular Therapy and Dendritic Cell-bank, Vrije Universiteit Brussel, Brussels, Belgium
               type:PostalAddress
            type:Organization
      name:Lieve Brochez
      affiliation:
            name:Universitair Ziekenhuis Gent (UZ Gent)
            address:
               name:Department of Medical Oncology, Universitair Ziekenhuis Gent (UZ Gent), Ghent, Belgium
               type:PostalAddress
            type:Organization
      name:Mark Kockx
      affiliation:
            name:Histogenex NV
            address:
               name:Histogenex NV, Antwerp, Belgium
               type:PostalAddress
            type:Organization
      name:Kris Thielemans
      affiliation:
            name:Vrije Universiteit Brussel
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               name:Department of Medical Oncology, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Brussels, Belgium
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      name:Department of Medical Oncology, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Brussels, Belgium
      name:Department of Medical Oncology, Universitair Ziekenhuis Gent (UZ Gent), Ghent, Belgium
      name:Laboratory of Molecular and Cellular Therapy and Dendritic Cell-bank, Vrije Universiteit Brussel, Brussels, Belgium
      name:Histogenex NV, Antwerp, Belgium
      name:Histogenex NV, Antwerp, Belgium
      name:Department of Medical Oncology, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Brussels, Belgium
      name:Laboratory of Molecular and Cellular Therapy and Dendritic Cell-bank, Vrije Universiteit Brussel, Brussels, Belgium
      name:Department of Medical Oncology, Universitair Ziekenhuis Gent (UZ Gent), Ghent, Belgium
      name:Histogenex NV, Antwerp, Belgium
      name:Laboratory of Molecular and Cellular Therapy and Dendritic Cell-bank, Vrije Universiteit Brussel, Brussels, Belgium
      name:Department of Medical Oncology, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Brussels, Belgium
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