Observational studyInternational journal of urology : official journal of the Japanese Urological Association2026
A Minimum 3-Year Follow-Up of Nivolumab-Plus-Ipilimumab in Japanese Patients With Advanced or Metastatic Renal Cell Carcinoma: A Final Analysis of the J-ENCORE Study.
Observational study in International journal of urology : official journal of the Japanese Urological Association, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04043975 (Japanese Prospective Real World Registry of Nivolumab Plus Ipilimumab in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma), which is not on this map. Cited by 2 papers.
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.
Japanese Prospective Real World Registry of Nivolumab Plus Ipilimumab in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma (ARCC) Categorized Into IMDC Intermediate/Poor Risks (J-ENCORE)
Who cites it
2 citing papers in PubMed.
- Subsequent systemic therapy initiation after first-line discontinuation in metastatic renal cell carcinoma: insights from a Japanese real-world cohort.ESMO real world data and digital oncology · 2026Article
- Early Progressive Disease During Nivolumab Plus Ipilimumab Therapy Predicts Poor Survival in Japanese Patients with Advanced Renal Cell Carcinoma: A Single-Center 12-Week Landmark Study.Research and reports in urology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
Abstract
objectivesThe J-ENCORE study is a Japanese multicenter, prospective observational study involving patients with advanced or metastatic renal cell carcinoma treated with nivolumab-plus-ipilimumab combination as first-line treatment. Interim 1- and 2-year reports demonstrated efficacy and safety comparable to those of the CheckMate 214 trial, with sustained effects after nivolumab-plus-ipilimumab discontinuation, and explored outcome-associated factors. This final analysis of a minimum 3-year observation summarized long-term outcomes, including real-world second progression-free survival and overall survival, and explored outcome-associated factors.
methodsReal-world objective response rate, response duration, real-world progression-free survival, overall survival, treatment-related adverse events, and real-world second progression-free survival were evaluated. Outcome-associated factors were explored.
resultsThe study included 274 patients (68.2% aged ≥ 65 years; 42.0%, poor risk) from 37 sites, with a median follow-up of 47.4 (range, 36.5-59.0) months. Real-world objective response rate was 38.4%, with 30.5% maintaining ≥ 36 months response duration. Median real-world progression-free survival and second progression-free survival were 9.7 and 30.1 months, respectively, and 60.2% of patients survived for ≥ 36 months. Treatment-related adverse events of any grade, grade 3/4, and grade 5 occurred in 78.5%, 43.1%, and 1.1% of patients, respectively. No new treatment-related adverse events or increased frequencies were reported since the previous interim analyses. Multivariable analyses identified associations between overall survival and age, lactate dehydrogenase levels, and C-reactive protein levels, with favorable prognosis in patients with none or one of these factors.
conclusionsWe demonstrated long-term real-world outcomes of nivolumab-plus-ipilimumab. Our findings support prescriptions of nivolumab-plus-ipilimumab in real-world clinical practice. TRAIL REGISTRATION: UMIN Clinical Trials Registry: UMIN000036772 and ClinicalTrials.gov: NCT04043975.
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