Design, Implementation, and Interpretation of Clinical Trials of Cancer Immunotherapy

Immunotherapy is now an entrenched form of treatment for cancer patients, among the various established one’s such as immune checkpoint inhibitors, monoclonal antibodies, or chimeric antigen receptor (CAR) T-cell therapy. Established agents have shown promising clinical profile for treating various tumor types, but also demonstrated toxicity profiles. New strategies for trial design and selection of drug dose are in demand owing to classic hypothesis foist by cytotoxic agents. The main target of this chapter is compilation of FDA-approved drugs and current stage of study design of ongoing clinical trials of cancer immunotherapeutic agents. For the advancement in the effectuality of cancer immunotherapy, new approaches are needed, which collectively sum up optimal dose for study in later phases, or checking combination of drugs to enhance effectiveness and decrease toxicity.