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Datasets  >  clinical study dataset  >  DERMA-ER-DC 04 clinical tri...

DERMA-ER-DC 04 clinical trial of DC-based therapy of melanoma patients +/- CD40L activation

clinical study dataset

Our lab has data from an interim statistical analysis of the DERMA-ER-DC 04 trial (multipeptide loaded cytokine matured moDC +/- CD40L activation, 70 evaluated patients). This analysis for the first time showed a clinical correlation of induced immune responses as measured in the blood with outcome, as there have been so far statistically significantly less events in stage III patients showing good CTL reponses (IFN-y Elispot) to multiple class I and II peptides compared to low responders of the stage III cohort. Additional in vitro maturation of DC by CD40L (leucine zipper, Immunex) did not result in better immunity compard to standard cytokine cocktail matured DC.

The trial was closed in 2007. Ongoing monitoring has confirmed a clinical correlation of induced immunes responses. In stage IV patients very rapidly progressing patients showed in general weak immune responses after the first vaccinations. The strength and breadth of induced immune responses was, however, identical in patients living up to 24 months or significantly beyond 24 months. Interestingly, we could distinguish between these two groups by transcriptome analysis of pre-vaccination metastases in that long survivors had a preexisting “friendly” non-suppressive micromilieu. This is obviously an exciting finding and will influence future study design, and possibly allow a preselection of patients responsive to immune intervention.

created over 8 years ago (2 March 2009)    last modified over 5 years ago (28 September 2011)   [ RDF Rdf ]   [ RelFinder Relfinder ]