GU Cancers 2026 | Indi-Blade: induction ipilimumab, nivolumab, and chemoradiotherapy in MIBC
Jan-Jaap Mellema, MD, Netherlands Cancer Institute, Amsterdam, The Netherlands, describes results from the Phase II Indi-Blade trial (NCT05200988) of induction ipilimumab plus nivolumab followed by chemoradiotherapy as a bladder-sparing strategy for muscle-invasive bladder cancer (MIBC). The study met its primary endpoint, demonstrating encouraging two-year bladder-intact event-free survival and overall survival. These findings suggest combining potent systemic immunotherapy with consolidating chemoradiotherapy offers an effective option for preserving the bladder in patients with muscle-invasive disease. This interview took place at the 2026 ASCO GU Cancers Symposium in San Francisco, CA.
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Transcript
Definitely, so the Indi-Blade trial is a phase two study which we gave patients ipilimumab and nivolumab combination followed by a consolidative chemoradiotherapy in an effort to really broaden the population able to receive a bladder-sparing treatment and the idea for this came from the previous trial that was conducted by our research group which was the Nabuco trial in which patients with very bulky stage 3 tumors were shown to have very very high pathological complete response rate using this regimen and this also translated into very promising progression-free survival in this case that we might be able to incorporate this into a bladder preservation setting...
Definitely, so the Indi-Blade trial is a phase two study which we gave patients ipilimumab and nivolumab combination followed by a consolidative chemoradiotherapy in an effort to really broaden the population able to receive a bladder-sparing treatment and the idea for this came from the previous trial that was conducted by our research group which was the Nabuco trial in which patients with very bulky stage 3 tumors were shown to have very very high pathological complete response rate using this regimen and this also translated into very promising progression-free survival in this case that we might be able to incorporate this into a bladder preservation setting. And we set as a primary endpoint for this study, bladder-intact disease-free survival at two years, for which we had a target of 70%. And we met this primary endpoint at two years at 78%. And secondary endpoints of the study were overall survival, ctDNA analyses, and safety and though a bit premature maybe but overall survival was very encouraging at 96 percent there were no new safety signals observed in the course of the study and ctDNA analyses showed that it had a strong monitoring power with patients that would develop an event either remained ctDNA positive or became ctDNA positive at the time of the event and conversely that patients that were not experiencing the event either remained ctDNA negative from baseline throughout the study or became ctDNA negative at either the first or second response evaluations. And bladder-intact disease-free survival analysis by ctDNA status post immunotherapy showed that ctDNA negativity was highly associated with bladder-intact disease-free survival.
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