QuintilesIMS authors, along with members of the Clinical Operations Group at the Sarah Cannon Research Institute, collaborated in writing this White Paper entitled “Managing Multi-Arm Studies in an Evolving Immuno-Oncology Landscape.”  Immunotherapy is a treatment strategy that targets the host immune system, not the tumor itself.  Early successes have led to much excitement and to considerable investment in immuno-oncology research.  While the medical and clinical impact of these approaches promises to be enormous, the advances in immunotherapy development are adding tremendous complexity to the required clinical trials.  This paper therefore provides suggestions on how to prepare for a complex immuno-oncology study, and presents a successful Case Study.