Observational studyInternational journal of urology : official journal of the Japanese Urological Association2025
The Effectiveness and Safety Profile of Nivolumab-Plus-Ipilimumab in Previously Untreated Japanese Patients With Advanced or Metastatic Renal Cell Carcinoma (J-ENCORE Study).
Observational study in International journal of urology : official journal of the Japanese Urological Association, 2025. 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 5 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
5 citing papers in PubMed.
- One-Week Inflammatory Kinetics After First-Line Nivolumab Plus Ipilimumab in Metastatic Renal Cell Carcinoma: A Multicenter Landmark Analysis.Targeted oncology · 2026Article
- 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.International journal of urology : official journal of the Japanese Urological Association · 2026Observational
- 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
- Outcomes of Nivolumab-Plus-Ipilimumab in Metastatic Renal Cell Carcinoma: Second Interim Analysis of the J-ENCORE Study.International journal of urology : official journal of the Japanese Urological Association · 2026Observational
- Combination immunotherapy in Japanese patients with advanced renal cell carcinoma: bridging gaps between clinical trials, real-world evidence, and the potential value of adverse events-a narrative review.Translational cancer research · 2025Review
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
objectivesCombination therapy of nivolumab-plus-ipilimumab has been approved for advanced or metastatic renal cell carcinoma in Japan, but large-scale clinical data targeting Japanese patients is limited. To evaluate the early outcomes and factors related to early progression and response.
methodsJ-ENCORE is an ongoing multicenter, prospective, observational study of the effectiveness and safety of nivolumab-plus-ipilimumab for patients in Japan with advanced or metastatic renal cell carcinoma. The objective response rate, duration of response, progression-free survival, overall survival, incidence of adverse events, and factors related to early progression within 3 months, and response were assessed.
resultsWe included 274 patients (median age: 68 years, 24.8% aged ≥ 75 years, 78.8% male). The median follow-up was 23.4 months. The objective response rate was 36.8%. Among responders, 63.3% had progression-free survival > 12 months. The median progression-free survival was 9.9 months; the 12-month overall survival was 76.3%. Of the patients, 77.0% experienced treatment-related adverse events, 42.3% experienced grade 3-4 events, and 1.1% experienced treatment-related death. Early progression was associated with female sex, poor risk status, liver metastasis, high baseline C-reactive protein levels, and high neutrophil-to-lymphocyte ratios. Responders were less likely to have bone metastases. Limitations include the observational nature of the study and a relatively short follow-up period.
conclusionsThis is the first prospective, real-world study to demonstrate the effectiveness and safety of nivolumab-plus-ipilimumab in Japan, with the results comparable to those of CheckMate 214. These findings support the use of nivolumab-plus-ipilimumab, although further studies with longer follow-up on nivolumab-plus-ipilimumab are needed. TRAIL REGISTRATION: ClinicalTrials.gov identifier: NCT04043975; University Hospital Medical Information Network-Clinical Trial Registration: UMIN000036772.
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