An Ongoing Phase II Clinical Trial for Bladder Cancer

Satkunasivam based this clinical trial on the hypothesis that the combination strategy is safe, feasible and enhances the pathologic complete response rates relative to cisplatin-based chemotherapy or immune checkpoint inhibitor monotherapy. The 33 patients enrolled in this trial at Houston Methodist receive sasanlimab administration daily for a cycle of 28 days followed by the combination therapy for another 28 days. The primary endpoints were safety and feasibility of the combination therapy whereas the secondary endpoints included adverse events, surgical complication rates, quality of life, overall survival and recurrence-free survival. “Patients diagnosed with MIBC have a poor prognosis, especially if they are ineligible to receive neoadjuvant cisplatin-based chemotherapy,” said Satkunasivam. “The current standard of care in this population is radical cystectomy alone followed by systemic therapy at the time of disease relapse. Therefore, there is a clinically significant unmet need for novel neoadjuvant approaches in this population. RAD VACCINE MIBC will assess the safety and efficacy of neoadjuvant sasanlimab combined with SBRT as an in-situ vaccine in cisplatin-ineligible patients with MIBC. This study builds upon the promising role of radiation as an immune-stimulatory mechanism in the context of immune checkpoint inhibition. This combination therapy has the potential to be well tolerated and to improve loco-regional control for this patient population.”