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The trial is assessing the safety and tolerability of adaptive radiation therapy with concurrent sacituzumab govitecan in patients with MIBC.
In a recent interview, Laura Bukavina, MD, MPH, shared the background for the ongoing RAD-SG trial (NCT05833867), which is assessing the safety and tolerability of adaptive radiation therapy in combination with the investigational agent sacituzumab govitecan in patients with muscle-invasive bladder cancer (MIBC). The design of the trial was shared at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California.
According to Dr. Bukavina, this combination may offer another bladder-preserving option for patients who are not eligible for tri-modal therapy with TURBT, radiation, and cisplatin-based chemotherapy.
In total, the trial plans to enroll 20 patients with MIBC.1 Those enrolled in the study will receive 8 mg/kg of intravenous sacituzumab govitecan on days 1 and 8 of a 21-day cycle with concurrent adaptive radiation.
The primary outcome measure is the rate of acute dose-limiting toxicities, and the econdary outcome measure is the bladder intact event-free survival. The investigators will also assess potential biomarkers of response, the correlation between pre-treatment imagine and treatment response, and imaging changes, among other measures.
Primary completion of the study is expected in December 2025.
REFERENCE
1. Adaptive RADiation Therapy with Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer. ClinicalTrials.gov. Last updated December 30, 2024. Accessed March 17, 2025. https://clinicaltrials.gov/study/NCT05833867