PURPOSE: There is a significant unmet need for new and efficacious therapies in urothelial cancer (UC). To provide recommendations on appropriate clinical trial designs across disease settings in UC, the Society for Immunotherapy of Cancer (SITC) and the International Bladder Cancer Group (IBCG) convened a multidisciplinary, international consensus panel. METHODS: Through open communication and scientific debate in small- and whole-group settings, surveying, and responses to clinical questionnaires, the consensus panel developed recommendations on optimal definitions of the disease state, end points, trial design, evaluations, sample size calculations, and pathology considerations for definitive studies in low- and intermediate-risk nonmuscle-invasive bladder cancer (NMIBC), high-risk NMIBC, muscle-invasive bladder cancer in the neoadjuvant and adjuvant settings, and metastatic UC. The expert panel also solicited input on the recommendations through presentations and public discussion during an open session at the 2021 Bladder Cancer Advocacy Network (BCAN) Think Tank (held virtually). RESULTS: The consensus panel developed a set of stage-specific bladder cancer clinical trial design recommendations, which are summarized in the table that accompanies this text. CONCLUSION: These recommendations developed by the SITC-IBCG Bladder Cancer Clinical Trial Design consensus panel will encourage uniformity among studies and facilitate drug development in this disease.

BCG Oncology Phoenix AZ

Carolina Urologic Research Center Myrtle Beach SC

Center for Cancer Research National Cancer Institute NIH Bethesda MD

Department of Genitourinary Medical Oncology Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Houston TX

Department of Genitourinary Oncology H Lee Moffitt Cancer Center Tampa FL

Department of Hematology and Medical Oncology Cleveland Clinic Taussig Cancer Institute Cleveland OH

Department of Medicine Division of Oncology University of Washington; Clinical Research Division Fred Hutchinson Cancer Center Seattle WA

Department of Pathology Medical University of Vienna Vienna Austria

Department of Radiation Oncology Massachusetts General Hospital Harvard Medical School Boston MA

Department of Urologic Sciences University of British Columbia Vancouver British Columbia Canada

Department of Urology Fundació Puigvert Universitat Autònoma de Barcelona Barcelona Spain

Department of Urology North York General Hospital Toronto Ontario Canada

Department of Urology Rush University Medical Center Chicago IL

Department of Urology Teaching Hospital Motol 2nd Faculty of Medicine Charles University Prague Czech Republic

Department of Urology The University of Texas MD Anderson Cancer Center Houston TX

Department of Urology University of Washington Fred Hutchinson Cancer Center Seattle WA

Division of Urology Department of Surgery University of Pennsylvania Philadelphia PA

EAU NMIBC Guidelines Panel Arnhem the Netherlands

Icahn School of Medicine at Mount Sinai Tisch Cancer Institute New York NY

Johns Hopkins Greenberg Bladder Cancer Institute Johns Hopkins University Baltimore MD

Patient Advocate Bladder Cancer Advocacy Network Bethesda MD

Queen Mary University of London London United Kingdom

Radboud University Medical Center Nijmegen the Netherlands

Scott Department of Urology Dan L Duncan Cancer Center Baylor College of Medicine Houston TX

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