An ad hoc committee will plan and host a 1.5-day public workshop that will examine the opportunities to improve the clinical development of immune checkpoint inhibitors for cancer therapy, including in the context of site-agnostic indications. The workshop will feature invited presentations and panel discussions on topics that may include the challenges and opportunities for improving:

• The development, validation, and standardization of biomarkers for patient selection.
• The assessment of safety and efficacy/clinical benefit in clinical trials.
• Innovations in clinical development programs for combination treatment strategies, such as approaches for prioritizing potential combinations (including multi-modal therapy), the role of preclinical modeling to identify promising combinations, and mechanisms for facilitating access to the best drug candidates for combination trials.
• Evidence requirements and decision making in drug development and regulatory evaluation for site-agnostic indications.
• Collaboration and information exchange among clinicians, researchers, and the pharmaceutical and diagnostic industries, including precompetitive collaboration, especially for the development of biomarkers predictive of immune-related toxicities and treatment response.

The 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.