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Abstract
Phase I, II and III clinical trials have shown that immunologic tolerance can be abrogated against specific tumor-associated antigens: but that the immunologic readouts are suboptimal in determining whether a trial can or should go forward in its development. While vaccines have been associated with declines in prostate-specific antigen, with occasional changes in scans by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, nevertheless, prostate vaccines alone appear to be insufficient to generate significant antitumor effects. Therefore, vaccines given in combination with cytokines or inhibitors of checkpoint molecules may not only enhance efficacy, but also validate the role of immune cells to effect the antitumor response. However, no one approach has been able to show improved overall survival. This article reviews the current issues and potential resolutions as to how we might go forward in developing and interpreting immunologic trials.
Financial & competing interests disclosure
The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.