1. Adjuvant dendritic cell therapy in stage IIIB/C melanoma:the MIND-DC randomized phase III trial
- Author
-
Bol, Kalijn F., Schreibelt, Gerty, Bloemendal, Martine, van Willigen, Wouter W., Hins-de Bree, Simone, de Goede, Anna L., de Boer, Annemiek J., Bos, Kevin J.H., Duiveman-de Boer, Tjitske, Olde Nordkamp, Michel A.M., van Oorschot, Tom G.M., Popelier, Carlijn J., Pots, Jeanne M., Scharenborg, Nicole M., van de Rakt, Mandy W.M.M., de Ruiter, Valeska, van Meeteren, Wilmy S., van Rossum, Michelle M., Croockewit, Sandra J., Koeneman, Bouke J., Creemers, Jeroen H.A., Wortel, Inge M.N., Angerer, Caroline, Brüning, Mareke, Petry, Katja, Dzionek, Andrzej, van der Veldt, Astrid A., van Grünhagen, Dirk J., Werner, Johanna E.M., Bonenkamp, Johannes J., Haanen, John B.A.G., Boers-Sonderen, Marye J., Koornstra, Rutger H.T., Boomsma, Martijn F., Aarntzen, Erik H.J., Gotthardt, Martin, Nagarajah, James, de Witte, Theo J.M., Figdor, Carl G., de Wilt, Johannes H.W., Textor, Johannes, de Groot, Jan Willem B., Gerritsen, Winald R., de Vries, I. Jolanda M., Bol, Kalijn F., Schreibelt, Gerty, Bloemendal, Martine, van Willigen, Wouter W., Hins-de Bree, Simone, de Goede, Anna L., de Boer, Annemiek J., Bos, Kevin J.H., Duiveman-de Boer, Tjitske, Olde Nordkamp, Michel A.M., van Oorschot, Tom G.M., Popelier, Carlijn J., Pots, Jeanne M., Scharenborg, Nicole M., van de Rakt, Mandy W.M.M., de Ruiter, Valeska, van Meeteren, Wilmy S., van Rossum, Michelle M., Croockewit, Sandra J., Koeneman, Bouke J., Creemers, Jeroen H.A., Wortel, Inge M.N., Angerer, Caroline, Brüning, Mareke, Petry, Katja, Dzionek, Andrzej, van der Veldt, Astrid A., van Grünhagen, Dirk J., Werner, Johanna E.M., Bonenkamp, Johannes J., Haanen, John B.A.G., Boers-Sonderen, Marye J., Koornstra, Rutger H.T., Boomsma, Martijn F., Aarntzen, Erik H.J., Gotthardt, Martin, Nagarajah, James, de Witte, Theo J.M., Figdor, Carl G., de Wilt, Johannes H.W., Textor, Johannes, de Groot, Jan Willem B., Gerritsen, Winald R., and de Vries, I. Jolanda M.
- 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 < 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.
- Published
- 2024