RegistrationSITC Neoadjuvant InitiativesNeoadjuvant Task Force

Summit Overview

Program Summary

The Society for Immunotherapy of Cancer (SITC) will host a summit on The Future of Neoadjuvant Clinical Trial Design on June 26, 2025. The virtual summit is a free, public event that features invited speakers, expert panel discussions, and attendee question and answer periods. The multi-stakeholder virtual summit will feature expert faculty presenters at the forefront of perioperative immunotherapy and clinical trial design. The SITC Summit on The Future of Neoadjuvant Clinical Trial Design will focus 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 will be 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 will conclude 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 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.

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Summit Goals & Objectives

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.

Neoadjuvant Task Force & Initiatives

The virtual summit is 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)
    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
    Princess Margaret Cancer Centre
  • Solange Peters, MD, PhD
    Lausanne University and ESMO
  • Mark Yarchoan
    Johns Hopkins University

Summit Agenda

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

Discussion 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

12:05–12:15 p.m. EDT

Panel Discussion
All session speakers, moderated by Dr. Forde

Session II: Clinical Trials of Neoadjuvant and Perioperative Immunotherapy

12:15–12:35 p.m. EDT

Statistician point-counterpart
Megan Othus, PhD – Fred Hutchinson Cancer Center

Pallavi Mishra-Kalyani, PhD – FDA

12:35–12:55 p.m. EDT

Lessons learned from the I-SPY and NeoCOAST-2 trials
Tina Cascone, MD – The University of Texas MD Anderson Cancer Center

12:55–1:10 p.m. EDT

Optimizing treatment intensity in neoadjuvant and perioperative trials
Christian Blank, MD – The Netherlands Cancer Institute

1:10–1:20 p.m. EDT

Panel Discussion
All session speakers and Andrea Ferris - LUNGevity

1:20–1:35 p.m. EDT

Break

Session III: Neoadjuvant Therapy Across Cancer Types

Part A: Disease experts give quick burst talks showcasing state-of-the-art data in a specific cancer type

1:35–1:38 p.m. EDT

Hepatocellular carcinoma
Mark Yarchoan, MD – Johns Hopkins University

1:38–1:41 p.m. EDT

Esophageal/gastric cancer

Ronan Kelly, MD, MBA, FASCO – Baylor University Medical Center

1:41–1:44 p.m. EDT

MSI-high colorectal cancers

1:44–1:47 p.m. EDT

Merkel cell carcinoma
Shailender Bhatia, MD – University of Washington

1:47–1:50 p.m. EDT

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

1:50–1:53 p.m. EDT

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

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