(UroToday.com) The American Urological Association's 2026 Annual Meeting, between May 15 – May 18, 2026 in Washington D.C., was host to the Society of Urologic Oncology (SUO) Session. Dr. Siamak Daneshmand presented the SUO-Clinical Trials Consortium (SUO-CTC) Bladder Cancer Trials Update.
Dr. Daneshmand began the SUO-Clinical Trials Consortium (SUO-CTC) Session by reviewing the expanding clinical trial landscape in NMIBC, highlighting several ongoing and emerging studies evaluating novel intravesical therapies and bladder-sparing treatment strategies. He noted that the current trial portfolio includes studies such as ADVANCED-2, PIVOT-006, CORE-008, ABLE-22, ABLE-32, and LEGEND, while newer additions to the portfolio include SURF302, TU100P2T5, and RESCUE. These studies reflect the continued effort to develop innovative therapeutic approaches for patients with high-risk NMIBC, particularly in the BCG-unresponsive setting.
Protara Therapeutics (ADVANCED-2)Dr. Daneshmand first reviewed ADVANCED-2, a study evaluating intravesical TARA-002 in patients with high-grade NMIBC. The trial enrolled 102 patients with CIS ± Ta/T1 disease and included both BCG-naïve and BCG-unresponsive cohorts. Cohort A enrolled 27 BCG-naïve patients, while Cohort B included 75 patients with BCG-unresponsive disease. He noted that the study is being led within the SUO-CTC network by Dr. Mark Tyson.
Dr. Daneshmand noted that ADVANCED-2 continues to actively accrue across North America, with 33 sites currently enrolling and an additional 11 sites in the start-up phase, for a total of 44 participating centers. Importantly, 82% of North American sites are members of the SUO-CTC network. To date, 119 patients have been screened and 66 enrolled across North America, with the vast majority of screening and enrollment occurring at SUO-CTC sites, accounting for 93% of screened patients and 98% of enrolled patients. The top enrolling sites are summarized below:
CG Oncology - PIVOT-006
PIVOT-006 is a phase 3 trial evaluating cretostimogene grenadenorepvec following TURBT compared with TURBT alone in patients with intermediate-risk NMIBC. The study plans to enroll 366 patients and is being led within the SUO-CTC network by Dr. Trinity Bivalacqua.
Dr. Daneshmand noted that recruitment for PIVOT-006 has now been completed. The study included 93 active sites across North America, 82% of which were SUO-CTC member institutions. Importantly, the SUO-CTC network accounted for the majority of trial activity, contributing 79% of screened patients and 81% of total enrollment, with 295 of the 366 enrolled patients coming from SUO-CTC sites. The top enrolling institutions are shown below.
CG Oncology - CORE-008
Dr. Daneshmand also reviewed CORE-008, an ongoing phase 2 multi-arm, multi-cohort open-label study evaluating the safety and efficacy of cretostimogene grenadenorepvec in patients with high-risk NMIBC. The trial includes multiple cohorts, with planned enrollment of up to 50 patients in Cohort A and up to 150 patients in Cohort B. He noted that the study is being led within the SUO-CTC network by himself.
Currently, 84 sites across North America are either active or in the activation phase for CORE-008, with 71% belonging to the SUO-CTC network. To date, 143 patients have been screened and 109 enrolled, with SUO-CTC sites contributing the majority of trial activity, accounting for 71% of screened patients and 69% of enrolled patients, and the top recruiting institutions are summarized below:
Ferring - ABLE-22
Dr. Daneshmand next highlighted ABLE-22, a phase 3 randomized multicenter open-label trial evaluating intravesical nadofaragene firadenovec either alone or in combination with chemotherapy (gemcitabine/docetaxel) or immunotherapy (pembrolizumab) in patients with high-grade BCG-unresponsive NMIBC. The study plans to enroll 250 patients and is being led within the SUO-CTC network by Dr. Sia Daneshmand.
Currently, 35 sites across North America are either active or in the activation phase for ABLE-22, with 74% belonging to the SUO-CTC network. Early accrual data demonstrated substantial contribution from SUO-CTC institutions, which accounted for 88% of screened patients and 92% of enrolled patients to date, with 11 of the first 12 enrolled patients originating from SUO-CTC sites, shown below:
Ferring - ABLE-32
ABLE-32 is a multicenter open-label randomized phase 3b trial evaluating nadofaragene firadenovec administered every 3 months versus observation in patients with intermediate-risk NMIBC. The study plans to enroll 454 patients and is being led within the SUO-CTC network by Dr. Vikram Narayan. At the time of presentation, 43 sites had been activated across North America, with 72% belonging to the SUO-CTC network. Overall, 95 patients had been screened and 58 enrolled, with SUO-CTC sites accounting for 73% of screened patients and 67% of enrolled patients. The top enrolling sites are shown below:
enGene – LEGEND
Dr. Daneshmand next highlighted LEGEND, a phase 1/2 study evaluating intravesical EG-70 in patients with BCG-unresponsive high-risk NMIBC, as well as patients who are BCG-naïve or received incomplete BCG therapy. The trial plans to enroll 290 patients across multiple cohorts, including BCG-refractory disease, BCG-naïve/BCG-exposed disease, and papillary-only BCG-refractory disease. The study is being led within the SUO-CTC network by Dr. Anne Schuckman.
At the time of presentation, 57 sites across North America were active or in the activation phase for LEGEND, with 95% belonging to the SUO-CTC network. Importantly, SUO-CTC sites accounted for nearly all trial activity to date, contributing 96% of both screened and enrolled patients, including 163 of the first 169 enrolled patients. The top enrolling sites are shown below:
SURF302
Dr. Daneshmand also reviewed SURF302, a phase 2 multicenter open-label study evaluating TYRA-300 in patients with FGFR3-altered low-grade intermediate-risk NMIBC. The study plans to enroll 90 patients and represents an effort to further develop biomarker-driven targeted therapy approaches in NMIBC. At the time of presentation, the SUO-CTC principal investigator had not yet been finalized, with site recruitment expected to begin in November 2025.
He also highlighted TU100P2T5, a randomized double-blind placebo-controlled phase 2 trial evaluating TU-100 (Daikenchuto herbal therapy) as an adjunct to enhanced recovery after surgery (ERAS) pathways in patients undergoing radical cystectomy. The study plans to enroll 120 patients and aims to further optimize perioperative recovery strategies following cystectomy. At the time of presentation, the SUO-CTC principal investigator had not yet been designated, with site recruitment anticipated to begin in December 2025.
Relmada – RESCUELastly, Dr. Daneshmand reviewed RESCUE, a phase 3 study evaluating the efficacy and safety of NDV-01 in patients with NMIBC. The SUO-CTC is currently recruiting for Cohort 2, an open-label multicenter single-arm portion of the study evaluating NDV-01 across two NMIBC populations. Planned enrollment includes 117 patients overall, with 87 patients in Cohort 2a and 30 patients in Cohort 2b. At the time of presentation, the SUO-CTC principal investigator had not yet been determined, and site recruitment is expected to open soon.
Presented by: Siamak Daneshmand, MD, Professor of Urology and Medicine (Clinical Scholar), Director of Urologic Oncology and Clinical Research, Keck School of Medicine, University of Southern California, USC Norris Comprehensive Cancer Center, Los Angeles, CA
Written by: Julian Chavarriaga, MD, Clinical Assistant Professor, Urologic Oncologist, Department of Urology at Penn State Health @chavarriagaj on Twitter during the American Urological Association (AUA) 2026 Annual Meeting, Washington, DC, Fri, May 15 – Mon, May 18, 2026.