Trial reportESMO open2026
Nivolumab plus gemcitabine-cisplatin for unresectable or metastatic urothelial carcinoma: health-related quality-of-life analyses from the phase III CheckMate 901 trial.
Trial report in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn the phase III CheckMate 901 trial, nivolumab plus standard-of-care gemcitabine-cisplatin chemotherapy followed by nivolumab monotherapy significantly prolonged overall survival and progression-free survival versus gemcitabine-cisplatin alone in cisplatin-eligible patients with unresectable or metastatic urothelial carcinoma (UC). Here, using patient-reported outcome (PRO) data from CheckMate 901, we report effects of adding nivolumab to gemcitabine-cisplatin on health-related quality of life (HRQoL). PATIENTS AND
methodsPRO assessments [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and EuroQol 5-Dimension 5-Level (EQ-5D-5L)] were scheduled for both arms through the first 6 months of treatment (combination phase), and for the nivolumab plus gemcitabine-cisplatin arm thereafter (monotherapy phase). The prespecified primary PRO scale of interest was QLQ-C30 global health status/quality of life (QoL). Secondary scales of interest included QLQ-C30 physical functioning, role functioning, and fatigue, and the EQ-5D-5L visual analog scale. Noninferiority analysis involved a mixed-effect model for repeated measures to estimate differences in least-squares mean changes from baseline to week 16. The proportions of patients with meaningful changes were calculated using prespecified thresholds.
resultsIn total, 524 patients were analyzed (nivolumab plus gemcitabine-cisplatin, n = 276; gemcitabine-cisplatin alone, n = 248). Overall least-squares mean changes through week 16 indicated the noninferiority of nivolumab plus gemcitabine-cisplatin versus gemcitabine-cisplatin alone for global health status/QoL and all secondary scales. At week 16, the proportions of patients with meaningful changes in global health status/QoL (improvement, 29.2% versus 23.0%; deterioration, 28.3% versus 30.4%) and all secondary PRO scales were similar in both arms.
conclusionsAdding nivolumab to gemcitabine-cisplatin did not worsen HRQoL compared with gemcitabine-cisplatin alone in the first 16 weeks of therapy. These findings support nivolumab plus gemcitabine-cisplatin as standard first-line therapy for cisplatin-eligible patients with unresectable or metastatic UC.
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