Summit FlyerEnduring MaterialsSITC Neoadjuvant InitiativesNeoadjuvant Task Force

Summit Overview

Program Summary

The Society for Immunotherapy of Cancer (SITC) hosted a 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.

Problem Statement

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 provided 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 identified 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.

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Summit Goals & Objectives

The primary objective of the SITC Summit on The Future of Neoadjuvant Clinical Trial Design was 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 included 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.

Neoadjuvant Task Force & Initiatives

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.

Neoadjuvant Clinical Trial Design Working Group

Patrick Forde, MD

CHAIR

Patrick Forde, MD
Trinity College Dublin

  • Tina Cascone, MD
    The University of Texas MD Anderson Cancer Center
  • Andrea Ferris, MBA
    LUNGevity
  • Italia Grenga, MD
    AstraZeneca
  • Erin Larkins, MD
    FDA
  • Jason Luke, MD, FACP
    UPMC
  • Grainne O'Kane, MD
    St. Vincents University Hospital and University College Dublin
  • Solange Peters, MD, PhD
    Lausanne University and ESMO
  • Mark Yarchoan, MD
    Johns Hopkins University

Summit Agenda
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SITC Summit on the Future of Neoadjuvant Clinical Trial Design
Thursday, June 26, 2025: 11 a.m.–3 p.m. EDT
11–11:05 a.m. EDT Welcome
Patrick Forde, MD – Trinity College Dublin
Session I: Neoadjuvant and Perioperative Immunotherapy
11:05–11:20 a.m. EDT Introductory talk
Paz Vellanki, MD, PhD – FDA
11:20–11:35 a.m. EDT Industry perspective on the contribution of phases in the neoadjuvant and perioperative settings
Leora Horn, MD – AstraZeneca
Harpreet Singh, MD – Precision for Medicine
11:35–11:50 a.m. EDT Future clinical trial design in the neoadjuvant and perioperative setting
John Heymach, MD, PhD – The University of Texas MD Anderson Cancer Center
11:50 a.m.–12:05 p.m. EDT Endpoints and making decisions about treatment
Solange Peters, MD, PhD – Lausanne University and ESMO
12:05–12:20 p.m. EDT Panel discussion
All session speakers, moderated by Dr. Forde
Session II: Clinical Trials of Neoadjuvant and Perioperative Immunotherapy
12:20–12:40 p.m. EDT Statistician point-counterpoint
Megan Othus, PhD – Fred Hutchinson Cancer Center
Pallavi Mishra-Kalyani, PhD – FDA
12:40–12:50 p.m. EDT Lessons learned from the NeoCOAST trials
Tina Cascone, MD, PhD – The University of Texas MD Anderson Cancer Center
12:50–1 p.m. EDT Surgeon perspective
Neil Gross, MD – The University of Texas MD Anderson Cancer Center
1–1:20 p.m. EDT Panel discussion
All session speakers and Brittany McKelvey, PhD – LUNGevity
1:20–1:35 p.m. EDT Break
Session III: Neoadjuvant and Perioperative Therapy Across Cancer Types
Part A: Disease experts give quick burst talks showcasing state-of-the-art data in a specific cancer type
1:35–1:55 p.m. EDT Hepatocellular carcinoma
Mark Yarchoan, MD – Johns Hopkins University

Esophageal/gastric cancer
Ronan Kelly, MD, MBA, FASCO – Baylor University Medical Center

MSI-high colorectal cancers
Michael Overman, MD – The University of Texas MD Anderson Cancer Center

Merkel cell carcinoma
Shailender Bhatia, MD – University of Washington

Urothelial cancer
Thomas Powles, MBBS, MD, MRCP – Queen Mary University of London

Head and neck cancers
Ravi Uppaluri, MD, PhD – Dana-Farber Cancer Institute/Brigham and Women's Hospital
Part B: Pathologist Perspective
1:55–2:10 p.m. EDT Pathologist perspective
Janis Taube, MD – Johns Hopkins University
Part C: Panel Discussion
2:10–2:55 p.m. EDT Panel discussion
All session speakers, moderated by Dr. Forde
2:55–3:00 p.m. EDT Closing remarks
Patrick Forde, MD – Trinity College Dublin