The Society for Immunotherapy of Cancer (SITC) hosted the Summit on The Future of Neoadjuvant Clinical Trial Design on June 26, 2025. The virtual summit was a free, public event that featured invited speakers, expert panel discussions, and attendee question and answer periods. The multi-stakeholder virtual summit featured expert faculty presenters at the forefront of perioperative immunotherapy and clinical trial design. The SITC Summit on The Future of Neoadjuvant Clinical Trial Design focused on two major topics: assessing the contribution of each treatment phase toward clinical efficacy and endpoints in clinical trials of neoadjuvant or perioperative immunotherapies for early-stage resectable cancers. These topics were addressed through reviewing data and insights from recent clinical trials of immunotherapy in the neoadjuvant/perioperative setting including I-SPY, NeoCOAST-2, and others. The program concluded with globally renowned faculty sharing state-of-the-art updates for a wide range of cancer types that have made unique contributions to understanding the biology and clinical development of neoadjuvant and perioperative therapies.
The virtual summit was an output of the Neoadjuvant Clinical Trial Design Working Group, which is part of the Neoadjuvant Task Force. The Neoadjuvant Task Force is chaired by Suzanne L. Topalian, MD, FAIO and Sapna P. Patel, MD. Learn more about the Neoadjuvant Task Force and its working groups.
Recent advances and approvals in neoadjuvant and perioperative immunotherapy for early-stage cancers has provided more treatment options and improved clinical outcomes for patients with resectable tumors. While neoadjuvant and perioperative immunotherapy is associated with clinical benefits, these treatments are associated with risks of toxicity and additional inconveniences and costs, so it is important to know the specific contributions of phase of treatment toward clinical efficacy. This program will provide an up-to-date overview of clinical trials of neoadjuvant and perioperative immunotherapy for resectable cancers, specific considerations for designing trials of neoadjuvant therapy for early-stage cancers, and potential clinical impacts of these discoveries and challenges. Didactic presentations and panel discussions will identify clinical and statistical strategies, challenges, and opportunities in the fields of neoadjuvant immunotherapy and clinical trial design for a variety of cancers, educating all attendees about this growing field and building collaborations that will advance neoadjuvant immunotherapy and improve patient outcomes.
The primary objective of the SITC Summit on The Future of Neoadjuvant Clinical Trial Design is to highlight recent advances, opportunities, and challenges in the field of neoadjuvant immunotherapy and how the field can optimize clinical trial design to test perioperative treatment regimens. Secondary goals include discussing informative trial endpoints to assess the clinical efficacy of perioperative treatment regimens for early-stage cancers, addressing statistical considerations in clinical trial design, and showcasing state-of-the-art data in neoadjuvant immunotherapy across a wide range of cancer types.
More information about the program, including the summit agenda, can be found here.
Meeting: SITC Summit on the Future of Neoadjuvant Clinical Trial Design; Speakers: Patrick Forde, MD, Paz Vellanki, MD, PhD, Leora Horn, MD, Harpreet Singh, MD, John Heymach, MD, PhD, Solange Peters, MD, PhD; Date: June 26, 202501:24:14
Meeting: SITC Summit on the Future of Neoadjuvant Clinical Trial Design; Speakers: Megan Othus, PhD, Pallavi Mishra-Kalyani, PhD, Tina Cascone, MD, PhD, Neil Gross, MD, Brittany McKelvey, PhD, Patrick Forde, MD; Date: June 26, 202501:03:56
Meeting: SITC Summit on the Future of Neoadjuvant Clinical Trial Design; Speakers: Mark Yarchoan, MD, Ronan Kelly, MD, MBA, FASCO, Michael Overman, MD, Shailender Bhatia, MD, Thomas Powles, MBBS, MD, MRCP, Ravi Uppaluri, MD, PhD, Janis Taube, MD, Patrick Forde, MD; Date: June 26, 202501:19:07