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Bladder Cancer Advocacy Network (BCAN) Bladder Cancer Think Tank 2025 |
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| CALGB 90601: From Lemons to Lemonade, Possibilities from Negative Cooperative Group Trials |
| Jonathan Rosenberg, MD |
| Jonathan Rosenberg reflected on the CALGB 90601 trial—a negative study in advanced bladder cancer that, despite its challenges and lack of survival benefit, yielded valuable biospecimens and spurred ongoing translational research. He emphasized that cooperative group trials can still have major scientific and community impact, even when outcomes fall short, and highlighted the lasting importance of collaboration, persistence, and biospecimen collection in advancing the field. |
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| Patients' Perspectives on Design of Clinical Trials
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| Darrell Nakagawa
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| At BCANTT 2025, patient advocate Darrell Nakagawa emphasized the critical importance of incorporating patient voices into bladder cancer clinical trial design. Drawing from his personal experience and advocacy work, he highlighted the need for patient-centered trial elements—such as broad eligibility, informed consent clarity, and real-world feasibility—and encouraged researchers to engage advocates as equal partners throughout the trial lifecycle.
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| Navigating Intergroup Collaboration in Clinical Trials; Lessons from Leading the S1806 Trial (SWOG/NRG)
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| Parminder Singh, MD
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| Parminder Singh shared lessons from leading the intergroup S1806 trial, a large phase III study evaluating atezolizumab plus chemoradiation for localized muscle-invasive bladder cancer. He emphasized the decade-long effort required to design, launch, and complete the trial, highlighting the complexity of intergroup collaboration, logistical hurdles, and the pivotal role of multidisciplinary teamwork.
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| EA8192 for UTUC Leadership and Career Opportunities in a Rare Tumor Cooperative Group Trial |
| Jean Hoffman-Censits, MD |
| Jeannie Hoffman-Censits shared insights from leading EA8192, a cooperative group trial investigating durvalumab plus chemotherapy in patients with high-grade upper tract urothelial carcinoma (UTUC). She emphasized how rare tumor trials like EA8192 offer not only scientific advancement but also leadership and career-building opportunities, despite challenges such as slow accrual and evolving treatment paradigms. |
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| The PRIME (S1602) Trial: Effectiveness of Different BCG Regimens in Patients with CIS, High-Grade Ta, or High-Grade T1 NMIBC |
| Robert Svatek, MD
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| Robert Svatek presented the PRIME (S1602) trial, a phase III study comparing the TICE and Tokyo BCG strains—with and without intradermal priming—for patients with high-grade non–muscle-invasive bladder cancer. The trial investigates whether the Tokyo strain is non-inferior to TICE and whether intradermal priming boosts immune response and outcomes. Dr. Svatek highlighted the importance of patient advocate involvement, strong mentorship, and rigorous trial design, underscoring that even trials without positive results can meaningfully advance the field.
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| Elucidating Effects of Nutrition on the Microbiome and Immunotherapy Efficacy |
| Brendan Guercio, MD |
| Brendan Guercio presented research linking diet, the gut microbiome, and immunotherapy outcomes in bladder cancer. His cohort study showed that higher dietary fiber intake was associated with significantly longer progression-free survival in patients receiving immune checkpoint blockade for metastatic urothelial carcinoma. Building on these findings, his team is now conducting a prospective study exploring how fiber and microbiome composition influence outcomes with enfortumab vedotin and pembrolizumab. |
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| Bio-Digital Avatars for Personalized Sequencing of Bladder Cancer Therapies |
| Bishoy Faltas, MD |
| Bishoy Faltas presented the development of bio-digital avatars using deep reinforcement learning and mechanistic modeling to personalize treatment sequencing for metastatic bladder cancer. These virtual patient models simulate tumor evolution and treatment response using clinical inputs like ctDNA and imaging, adapting therapy in real-time to delay resistance and improve outcomes. |
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| Lessons Learned from the SWOG S1011 Clinical Trial |
| Seth Lerner, MD, FACS |
| Seth Lerner reflected on key lessons from the SWOG S1011 trial, which compared limited versus extended pelvic lymph node dissection during radical cystectomy for bladder cancer. He emphasized the importance of early consensus-building, rigorous surgeon credentialing, and surgical quality control, which helped ensure trial consistency and timely accrual. |
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| Alliance A031501: AMBASSADOR Study. Managing a Cooperative Group Study in a Rapidly Evolving Treatment Landscape |
| Andrea Apolo, MD |
| Andrea Apolo shared insights from the AMBASSADOR (Alliance A031501) trial, a phase III study evaluating adjuvant pembrolizumab versus observation in patients with high-risk muscle-invasive urothelial carcinoma. Despite evolving standards of care and the early FDA approval of nivolumab, the trial demonstrated disease-free survival benefit across PD-L1 subgroups, contributing to pembrolizumab's inclusion in NCCN guidelines. |
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