The 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.
Real-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.
The 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.
We demonstrated long-term real-world outcomes of nivolumab-plus-ipilimumab. Our findings support prescriptions of nivolumab-plus-ipilimumab in real-world clinical practice.
UMIN Clinical Trials Registry: UMIN000036772 and ClinicalTrials.gov: NCT04043975.
International journal of urology : official journal of the Japanese Urological Association. 2026 Mar [Epub]
Shuzo Hamamoto, Masahiro Nozawa, Suguru Shirotake, Tomokazu Sazuka, Kazuyuki Numakura, Atsushi Mizokami, Tsunenori Kondo, Sei Naito, Takashige Abe, Kojiro Ohba, Go Kimura, Masayoshi Nagata, Shunta Onodera, Katsumi Yamaguchi, Hirotsugu Uemura
Department of Nephro-Urology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan., Department of Urology, Kindai University Faculty of Medicine, Sakai, Japan., Department of Uro-Oncology, Saitama Medical University International Medical Center, Hidaka, Japan., Department of Urology, Graduate School of Medicine, Chiba University, Chiba, Japan., Department of Urology, Akita University Graduate School of Medicine, Akita, Japan., Department of Integrative Cancer Therapy and Urology, Graduate School of Medical Science, Kanazawa University, Kanazawa, Japan., Department of Urology, Tokyo Women's Medical University Adachi Medical Center, Tokyo, Japan., Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan., Department of Renal and Genitourinary Surgery, Hokkaido University Graduate School of Medicine, Sapporo, Japan., Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan., Department of Urology, Nippon Medical School Hospital, Tokyo, Japan., Department of Urology, Juntendo University Hospital, Tokyo, Japan., Ono Pharmaceutical Co., Ltd., Osaka, Japan., Bristol Myers Squibb, Tokyo, Japan., Department of Innovative Medicine, Kindai University Faculty of Medicine, Sakai, Japan.