Pulse Brain · Growing Health Evidence Index
Tier 3 — Observational / field trialPeer-reviewed

High- or low-dose preoperative ipilimumab plus nivolumab in stage III urothelial cancer: the phase 1B NABUCCO trial

Jeroen van Dorp, Christodoulos Pipinikas, Britt B.M. Suelmann, Niven Mehra, Nick van Dijk, Giovanni Marsico, Maurits L. van Montfoort, Sophie Hackinger, Linde M. Braaf, Tauanne Amarante, Charlaine van Steenis, Kirsten McLay, Antonios Daletzakis, Daan van den Broek, Maaike W. van de Kamp, Kees Hendricksen, Jeantine M. de Feijter, Thierry N. Boellaard, Richard P. Meijer, Antoine G. van der Heijden, Nitzan Rosenfeld, Bas W.G. van Rhijn, Greg Jones, Michiel S. van der Heijden

Nature Medicine · 2023

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Summary

The NABUCCO trial investigated preoperative combination immunotherapy with ipilimumab and nivolumab at two dose levels in stage III urothelial cancer patients prior to radical cystectomy. As a phase 1B study, the trial assessed the tolerability and activity of this neoadjuvant approach to inform optimal dosing strategies for subsequent clinical development. The work was published in Nature Medicine in 2023 and reflects current interest in checkpoint inhibitor combinations as preoperative treatment in advanced urothelial malignancy.

UK applicability

This trial includes United Kingdom centres and investigates treatment protocols potentially applicable to NHS oncology practice. However, the findings are specific to stage III urothelial cancer and require integration with existing neoadjuvant treatment guidelines before broader implementation in UK clinical practice.

Key measures

Preoperative adverse events, pathological response rates, recurrence-free survival, overall survival, immunological biomarkers

Outcomes reported

The study evaluated safety and efficacy of two different dose levels of combined ipilimumab and nivolumab administered before surgical resection in patients with stage III urothelial cancer.

Theme
General food systems / other
Subject
Other / interdisciplinary
Study type
Research
Study design
Phase 1B clinical trial
Source type
Peer-reviewed study
Status
Published
Geography
Europe
System type
Human clinical
DOI
10.1038/s41591-022-02199-y
Catalogue ID
BFmor3gdee-8znd88

Topic tags

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