Pulse Brain · Growing Health Evidence Index
Tier 2 — RCT / large cohortPeer-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 checkpoint inhibitor therapy (ipilimumab plus nivolumab) at two dose levels in patients with stage III urothelial cancer. As suggested by the trial design, the study compared safety profiles and efficacy outcomes between high and low-dose regimens to inform optimal dosing strategies for neoadjuvant immunotherapy in this indication.

UK applicability

As a phase 1B trial in urothelial cancer, the findings may inform UK oncology practice guidelines and NHS treatment pathways for bladder cancer patients, though adoption would depend on cost-effectiveness assessment and integration with existing surgical protocols within UK cancer networks.

Key measures

Adverse events, dose-limiting toxicities, pathological complete response rates, major pathological response rates, recurrence-free survival

Outcomes reported

The study evaluated safety, tolerability, and efficacy of two dose regimens of combined ipilimumab and nivolumab as neoadjuvant therapy in stage III urothelial cancer patients prior to surgical resection.

Theme
General food systems / other
Subject
Other / interdisciplinary
Study type
Research
Study design
Phase 1B randomised controlled trial
Source type
Peer-reviewed study
Status
Published
Geography
United Kingdom
System type
Human clinical
DOI
10.1038/s41591-022-02199-y
Catalogue ID
BFmommpjky-vnuvqj

Topic tags

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