Definitions, End Points, and Clinical Trial Designs for Bladder Cancer

Definitions, End Points, and Clinical Trial Designs
for Bladder Cancer: Recommendations from
the Society for Immunotherapy of Cancer
and the International Bladder Cancer Group

On behalf of the Society for Immunotherapy of Cancer (SITC) and the International Bladder Cancer Group (IBCG), we are pleased to announce the publication of the “Definitions, End Points, and Clinical Trial Designs for Bladder Cancer: Recommendations From the Society for Immunotherapy of Cancer and the International Bladder Cancer Group,” in the Journal of Clinical Oncology. These recommendations provide a detailed clinical trial design guide to maximize the chance of capturing the benefit of medical therapies for each unique stage of bladder cancer, from low-risk non-muscle invasive bladder cancer (NMIBC) to metastatic disease.

SITC and IBCG formed a partnership to develop Expert Panel recommendations in response to a significant unmet need that still exists for standardized trials designed for new urothelial carcinoma (UC) treatments specific to stage and treatment approach. In this new manuscript, the Expert Panel discusses standardization of key clinical design elements to identify optimal treatment options and improve outcomes for patients. By providing standardized criteria, the paper also aims to benefit the field by allowing cancer researchers to develop more comparable and robust data sets for meta-analyses. 

Key Bladder Cancer Stage-Specific Recommendations:

  • Rationally selected endpoints
  • Eligibility criteria
  • Response measurement
  • Statistical analyses (including minimal value for effect and sample size considerations)
  • Pathology considerations 

SITC-IBCG Promo Fig - Final.png

Tweet 1 graphic alt - front page publication

Companion Education

To help provide a deeper understanding of the recommendations, SITC will host a companion online educational session in early 2024 with the manuscript authors serving as faculty for the program. This session will be available free-of-charge and held live to allow questions with the authors as well as hosted on-demand after the session is completed. More information on the session will be available in the coming months.  

SITC-IBCG Bladder Cancer Clinical Trial Design Expert Panel

CHAIR

Matthew D. Galsky, MD 
Mount Sinai Medical Center

CHAIR

Ashish M. Kamat, MD, MBBS, FACS
The University of Texas MD Anderson Cancer Center

Members

Andrea B. Apolo, MD — National Cancer Institute/Center for Cancer Research

Marek Babjuk, MD, PhD — Charles University, Praha

Trinity J. Bivalacqua, MD, PhD — University of Pennsylvania

Peter Black, MD, FACS, FRCSC — University of British Columbia

Roger Buckley, MD, FRCSC — North York General Hospital

Matthew T. Campbell, MD, MS — The University of Texas MD Anderson Cancer Center

Eva Comperat, MD, PhD — Sorbonne University

Jason Efstathiou, MD, PhD, DPHIL — Massachusetts General Hospital

Petros Grivas, MD, PhD — University of Washington

Shilpa Gupta, MD — Cleveland Clinic Taussig Cancer Institute

Neil J. Kurtz, MD — BCAN Representative

Donald Lamm, MD, FACS — BCG Oncology, AZ

Seth P. Lerner, MD, FACS — Baylor College of Medicine

Roger Li , MD — H Lee Moffitt Cancer Center

David J. McConkey, PhD — Johns Hopkins Greenberg Bladder Cancer Institute

Joan Palou Redorta, MD, PhD — Fundació Puigvert

Thomas Powles, MBBS, MD, MRCP — Queen Mary University of London

Sarah P Psutka , MD — University of Washington

Neal Shore, MD, FACS — Carolina Urologic Research Center

Gary D. Steinberg, MD — Perlmutter Cancer Center - New York University Langone Medical Center

Richard Sylvester, ScD — EAU NMIBC Guidelines Panel

J. Alfred Witjes MD, PhD — University Radboud

Arjun V. Balar, MD — Perlmutter Cancer Center - New York University Langone Medical Center

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