(UroToday.com) The Bladder Cancer Advocacy Network (BCAN) Bladder Cancer Think Tank 2025 held in Washington, D.C., United States, between July 30th and August 1st. was host to the Session: Lessons Learned from Clinical Trials. Dr. Jonathan Rosenberg discussed the CALGB 90601 study and titled his talk: From lemons to lemonade, possibilities from negative cooperative group trials.
Dr. Rosenberg began by highlighting one of the challenges with cooperative group trials, using CALGB 90601 as an example. It took three years just to secure approval and another six years to enroll the first patient in 2009. The last patient was accrued in 2014. The primary endpoint was overall survival, which further prolonged the study. Ultimately, CALGB 90601 was a negative trial.1 However, they were fortunate to collect valuable biospecimens, including plasma, primary tumors, and biopsies. The team received a DoD Translational Team Science Award, and the work continues across multiple institutions, now focusing on germline data and chemosensitivity-associated mutations. The timeline of the study is shown below.
Dr. Jonathan Rosenberg reflected on the CALGB 90601 trial, emphasizing key lessons learned from one of the longest and most challenging cooperative group efforts in advanced bladder cancer. He credited strong mentorship and sponsorship from leaders like Eric Small, Nick Vogelzang, and Walt Stadler as instrumental to pushing the trial forward at critical junctures. Despite the negative outcome, the trial still held clinical relevance when results were published in 2019, even if the therapeutic landscape shifted shortly thereafter. He acknowledged that future-proofing a trial is nearly impossible in a rapidly evolving field but underscored the importance of pushing ahead. He added, “Don’t listen to those who say it can’t be done.”
Importantly, the trial marked a turning point in the field, signaling the end of the bladder cancer therapeutic nihilism that had defined prior decades. Dr. Rosenberg stressed the importance of collecting biospecimens whenever feasible, even as such efforts face growing cost and logistical barriers. Thanks to thoughtful trial design, CALGB 90601 was able to bank plasma and archival tumor samples, which have since fueled multiple grants and publications. Ongoing translational work includes cDNA and tumor NGS, and the study remains a valuable scientific resource, despite its original endpoint falling short.
Dr. Rosenberg closed with a candid reflection: “Luck and showing up are 90% of the battle.” He emphasized that the value of participating in cooperative group efforts like CALGB 90601 extends far beyond trial accruals or being the study PI. While not everyone will lead a trial, the relationships built and collaborations forged across the oncology community are often the most enduring and impactful outcomes of these efforts.
Presented by: Jonathan Rosenberg, MD, Chief, Genitourinary Oncology Service, Division of Solid Tumor Oncology, Enno W. Ercklentz Chair, Memorial Sloan Kettering Cancer Center, New York, NY
Written by: Julian Chavarriaga, MD – Urologic Oncologist at Cancer Treatment and Research Center (CTIC) via Society of Urologic Oncology (SUO) Fellow at The University of Toronto. @chavarriagaj on Twitter during the Bladder Cancer Advocacy Network (BCAN) Bladder Cancer Think Tank 2025 held in Washington, D.C., United States, between July 30th and August 1st
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