Drug combination therapies have been intensively studied in oncology over the past several decades. With the development of dozens of new anti-cancer agents, hundreds of clinical trials are needed within the traditional randomized clinical trial paradigm to test all possible combination therapies for different cancer types which is not tangible. The creation of National Immunotherapy Coalition and White House Cancer Moonshot Task Force in early 2016 signifies the importance of the efforts undertaken by federal authorities, industry and academia in the fight against cancer. Statisticians undoubtedly play an important role in developing novel approaches to support these efforts.

While the length of the luncheon discussion is rather limited, it will be worthwhile to hear from participants about the following issues: (1) Use/comparison of algorithmic (rule-based) and model-based designs in dose finding for combination therapies, (2) Simultaneous modeling of efficacy and toxicity for combination agents, (3) Specifics of designing studies for molecularly targeted agents, in particular the validity of the assumption about monotonically increasing relationship between dose and efficacy, (4) Designing combination studies in immuno-oncology, (5) Use of combinatorial designs for drug combinations, (6) Regulatory issues when using novel trial designs (e.g., basket or umbrella) for combination therapies.