A Randomized, Double--blind, Placebo-controlled Phase III Study to Evaluate Active Immunization in Adjuvant Therapy of Patients with Stage IIIB and IIIC Melanoma with Natural Dendritic Cells Pulsed with Synthetic Peptides.

The aim of this study is to determine whether adjuvant treatment with nDC vaccination, after complete radical lymph node dissection or sentinel node procedure in stage IIIB and IIIC melanoma patients, improves recurrence-free survival (RFS) as compared to treatment with matching placebo.

Start Date01 Oct 2016

Sponsor / Collaborator

Radboud University Medical Center

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100 Clinical Results associated with nDC vaccination(Dutch National Health Care Institute)

100 Translational Medicine associated with nDC vaccination(Dutch National Health Care Institute)

100 Patents (Medical) associated with nDC vaccination(Dutch National Health Care Institute)

Literatures (Medical) associated with nDC vaccination(Dutch National Health Care Institute)

Nature CommunicationsQ1 · CROSS-FIELD

Adjuvant dendritic cell therapy in stage IIIB/C melanoma: the MIND-DC randomized phase III trial

Q1 · CROSS-FIELD

ArticleOA

Author: Bos, Kevin J H ; Hins-de Bree, Simone ; van Rossum, Michelle M ; Boers-Sonderen, Marye J ; Boomsma, Martijn F ; Pots, Jeanne M ; Haanen, John B A G ; de Witte, Theo J M ; Koornstra, Rutger H T ; Nagarajah, James ; de Groot, Jan Willem B ; Wortel, Inge M N ; de Vries, I Jolanda M ; Koeneman, Bouke J ; van Meeteren, Wilmy S ; van Grünhagen, Dirk J ; de Goede, Anna L ; de Wilt, Johannes H W ; Angerer, Caroline ; Werner, Johanna E M ; de Ruiter, Valeska ; Gerritsen, Winald R ; Gotthardt, Martin ; van der Veldt, Astrid A ; Duiveman-de Boer, Tjitske ; Scharenborg, Nicole M ; Bonenkamp, Johannes J ; Brüning, Mareke ; Petry, Katja ; van Willigen, Wouter W ; Bloemendal, Martine ; Croockewit, Sandra J ; Dzionek, Andrzej ; Aarntzen, Erik H J ; de Boer, Annemiek J ; van Oorschot, Tom G M ; Creemers, Jeroen H A ; Olde Nordkamp, Michel A M ; Bol, Kalijn F ; Schreibelt, Gerty ; Textor, Johannes ; Figdor, Carl G ; van de Rakt, Mandy W M M ; Popelier, Carlijn J

AbstractAutologous natural dendritic cells (nDCs) treatment can induce tumor-specific immune responses and clinical responses in cancer patients. In this phase III clinical trial (NCT02993315), 148 patients with resected stage IIIB/C melanoma were randomized to adjuvant treatment with nDCs (n = 99) or placebo (n = 49). Active treatment consisted of intranodally injected autologous CD1c+ conventional and plasmacytoid DCs loaded with tumor antigens. The primary endpoint was the 2-year recurrence-free survival (RFS) rate, whereas the secondary endpoints included median RFS, 2-year and median overall survival, adverse event profile, and immunological response The 2-year RFS rate was 36.8% in the nDC treatment group and 46.9% in the control group (p = 0.31). Median RFS was 12.7 months vs 19.9 months, respectively (hazard ratio 1.25; 90% CI: 0.88−1.79; p = 0.29). Median overall survival was not reached in both treatment groups (hazard ratio 1.32; 90% CI: 0.73−2.38; p = 0.44). Grade 3−4 study-related adverse events occurred in 5% and 6% of patients. Functional antigen-specific T cell responses could be detected in 67.1% of patients tested in the nDC treatment group vs 3.8% of patients tested in the control group (p < 0.001). In conclusion, while adjuvant nDC treatment in stage IIIB/C melanoma patients generated specific immune responses and was well tolerated, no benefit in RFS was observed.

Food & FunctionQ2 · MEDICINE

Impact of dietary fibers in infant formulas on gut microbiota and the intestinal immune barrier

Q2 · MEDICINE

Review

Author: Faas, Marijke M. ; Kong, Chunli ; Akkerman, Renate ; de Vos, Paul

This review updates current knowledge on the structure-specific effects of human milk oligosaccharides and non-digestible carbohydrates in infant formula on the colonization of the infants gut by the microbiota as well as the composition and maturation of the gut immune barrier.

100 Deals associated with nDC vaccination(Dutch National Health Care Institute)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Melanoma, Cutaneous Malignant	Phase 3	Netherlands	Radboud University Medical Center	01 Oct 2016

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02993315 (Pubmed) Manual	Phase 3	Melanoma Adjuvant	148	Autologous natural dendritic cells (nDCs)	(imiumlzoaz) = taiwawrwus oawzdpmnbz (ewgclwyaeh ) View more	Positive	23 Feb 2024
				Placebo	(imiumlzoaz) = nwdpdnehlw oawzdpmnbz (ewgclwyaeh ) View more

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nDC vaccination(Dutch National Health Care Institute)

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