A National Academies of Sciences, Engineering, and Medicine planning committee will plan and host a 1.5-day public workshop that will examine the current challenges related to resistance to immune modulator therapies for cancer and discuss potential policy levers that could help to overcome these challenges. The workshop will feature invited presentations and panel discussions on topics that may include:

· An overview of the unique types of immunotherapy resistance based on the causes of resistance, including whether resistance mechanisms vary among different agents, and gaps in current understanding.

· Policy challenges and opportunities to address the problem of resistance, including:

• Criteria to move single agents into clinical trials.
• Criteria to use single agents in combination therapy development (e.g., whether clinical response is necessary).
• Criteria to assess cancer immunotherapy combinations in early-phase clinical trials.
• The roles of preclinical modeling and clinical and predictive biomarkers (e.g., companion diagnostics, in vivo imaging) for assessing safety and efficacy.
• The types of clinical trial designs needed for regulatory approval.
• Use of big data to aid in determining the dominant drivers of cancer immunotherapy resistance and to predict immunotherapy responses.

The planning committee will develop the agenda for the workshop sessions, select and invite speakers and discussants, and moderate the discussions. A proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.