Pulse Brain · Growing Health Evidence Index
Tier 2 — RCT / large cohortPeer-reviewed

Nivolumab plus Gemcitabine–Cisplatin in Advanced Urothelial Carcinoma

Michiel S. van der Heijden, Guru Sonpavde, Thomas Powles, Andrea Necchi, Mauricio Burotto, Michael Schenker, Juan Pablo Sade, Aristotelis Bamias, Philippe Beuzeboc, Jens Bedke, Jan Oldenburg, Gurkamal Chatta, Yüksel Ürün, Dingwei Ye, Zhisong He, Begoña P. Valderrama, Ja Hyeon Ku, Yoshihiko Tomita, Jeiry Filian, Lily Wang, Daniela Purcea, M. PATEL, Federico Nasroulah, Matthew D. Galsky

New England Journal of Medicine · 2023

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Summary

This multicentre randomised controlled trial (CheckMate 901) evaluated the addition of nivolumab, a PD-1 immune checkpoint inhibitor, to standard first-line chemotherapy (gemcitabine-cisplatin) in advanced urothelial carcinoma. The combination therapy demonstrated significantly improved clinical outcomes compared to chemotherapy alone, supporting a new treatment paradigm for this aggressive malignancy.

Regional applicability

These findings are directly applicable to UK clinical practice, as nivolumab is available through the NHS and this trial establishes an evidence base for its use in combination chemotherapy regimens for advanced urothelial carcinoma within the UK healthcare system.

Key measures

Overall survival, progression-free survival, objective response rate, adverse events

Outcomes reported

The study measured overall survival, progression-free survival, objective response rates, and safety outcomes in patients with previously untreated advanced urothelial carcinoma receiving combination nivolumab plus gemcitabine-cisplatin versus gemcitabine-cisplatin alone.

Theme
Nutrition & health
Subject
Out of scope / non-food
Study type
Research
Study design
RCT
Source type
Peer-reviewed study
Status
Published
Geography
International
System type
Human clinical
DOI
10.1056/nejmoa2309863
Catalogue ID
BFmoef2rp1-brc42m

Topic tags

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