Trial reportThe oncologist2026
Identification of key symptoms impacting HRQOL in advanced renal cell carcinoma: nivolumab plus cabozantinib versus sunitinib in CheckMate 9ER.
Trial report in The oncologist, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03141177 (A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma), which is not on this map. Not yet cited in PubMed.
What it found
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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.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
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Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
backgroundNivolumab plus cabozantinib demonstrated significantly better clinical and patient-reported outcomes (PROs) compared with sunitinib as first-line therapy for advanced renal cell carcinoma (aRCC) in CheckMate 9ER. This post-hoc analysis identified key factors contributing to improvements in health-related quality of life (HRQOL) in these patients. MATERIALS AND
methodsMediation analyses were conducted using first-year CheckMate 9ER data to delineate treatment effects as reflected by HRQOL improvements measured with the EuroQoL 5-Dimension 3-Level questionnaire (EQ-5D-3L) and 19-item Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19) Functional Well-Being Subscale (FKSI-FWB). The incremental benefits of nivolumab plus cabozantinib over sunitinib were partitioned into mediated effects through symptom and emotional well-being improvements (FKSI-19 scales).
resultsNivolumab plus cabozantinib (n = 323) resulted in significantly greater improvement in EQ-5D utility versus sunitinib (n = 328; difference = 0.08 [95% confidence interval [CI], 0.05-0.12]) and numerically greater FKSI-FWB improvement (difference = 0.22 [95% CI, -0.19 to 0.63]), both primarily driven by greater reductions in fatigue, pain, shortness of breath, and cough, and improvements in emotional well-being (all P < 0.05). Reduced fatigue was the largest contributor to gains in both scales (24.0% and 21.1% of total mediated effect, respectively); improvement in emotional well-being accounted for 5.0% and 17.2% of the total mediated effect.
conclusionThese findings highlight underlying pathways contributing to HRQOL improvement in patients with aRCC receiving nivolumab plus cabozantinib. These data suggest that treatment with nivolumab plus cabozantinib is associated with an improvement in symptoms that can be quantified using PRO measures, supporting the utility of incorporating patient-centric outcomes into treatment decision making. CLINICALTRIALS.GOV: NCT03141177.
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