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

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

Nature Communications, 2024, vol. 15, issue 1, 1-10

Abstract: Abstract Autologous 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

Date: 2024
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DOI: 10.1038/s41467-024-45358-0

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