Bladder Cancer Coverage from Every Angle

Neoadjuvant Ipilimumab Plus Nivolumab Under Study in Urothelial Carcinoma

By: Cordi Craig
Posted: Thursday, December 3, 2020

Although patients with urothelial carcinoma often face high disease recurrence rates, new research suggests that a neoadjuvant immunotherapy combination of nivolumab and ipilimumab may be a potential treatment option. The study, published in Nature Medicine, indicated that most of the patients treated with immunotherapy maintained their scheduled surgery date, and many reported a significant decrease in tumor size.

“Patients with bladder cancer at this stage have a high risk of relapse but not many good treatment options, especially when the cancer has spread to the lymph nodes,” senior study author Michiel S. van der Heijden, MD, PhD, of the Netherlands Cancer Institute, stated in an institutional press release. “The results of this study can hopefully benefit these patients’ prospects.”

The NABUCCO trial included 24 patients with stage III, locally advanced urothelial carcinoma. The patients received two doses of ipilimumab and two doses of nivolumab, followed by resection. The cancer had not yet spread through the bloodstream among any of the patients. 

Of the 24 enrolled patients, 23 patients (96%) underwent resection within 12 weeks of preoperative immunotherapy. About half of the patient pool (55%) reported grade 3 and 4 immune-related adverse events. When clinically insignificant laboratory abnormalities were excluded, 41% of patients reported grade 3 and 4 adverse events.

Of note, 11 patients (45%) achieved a pathologic complete response. The research team found no remaining invasive disease in more than half of the patient pool (58%; n = 14). The recorded complete responses were independent of the presence of baseline CD8-positive or T-effector signatures, contrary to previous studies using anti–PD-1 or anti–PD-L1 monotherapy.

Disclosure: For full disclosures of the study authors, visit

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