Evidence map›Paper›PMID 41292059›Full record

Observational studyInternational journal of urology : official journal of the Japanese Urological Association2026

Outcomes of Nivolumab-Plus-Ipilimumab in Metastatic Renal Cell Carcinoma: Second Interim Analysis of the J-ENCORE Study.

Tomokazu Sazuka, Katsunori Tatsugami, Suguru Shirotake, Shuzo Hamamoto, Masahiro Nozawa, Kazuyuki Numakura, Atsushi Mizokami, Tsunenori Kondo, Sei Naito, Takashige Abe and 5 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT04043975 completednot on this map

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)

TypeobservationalSponsorBristol-Myers SquibbRan2019 to 2024Enrolled286ConditionsAdvanced or Metastatic Renal Cell Carcinoma
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Observational
  3. 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 · 2026
    Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Tomokazu SazukaDepartment of Urology, Graduate School of Medicine, Chiba University, Chiba, Japan.ORCID https://orcid.org/0000-0002-8902-7853
Katsunori TatsugamiDepartment of Urology, Kitakyushu Municipal Medical Center, Fukuoka, Japan.
Suguru ShirotakeDepartment of Uro-Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
Shuzo HamamotoDepartment of Nephro-Urology, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan.ORCID https://orcid.org/0000-0002-9968-7468
Masahiro NozawaDepartment of Urology, Kindai University Faculty of Medicine, Osaka, Japan.
Kazuyuki NumakuraDepartment of Urology, Akita University Graduate School of Medicine, Akita, Japan.
Atsushi MizokamiDepartment of Integrative Cancer Therapy and Urology, Graduate School of Medical Science, Kanazawa University, Ishikawa, Japan.ORCID https://orcid.org/0000-0002-5643-2182
Tsunenori KondoDepartment of Urology, Tokyo Women's Medical University Adachi Medical Center, Tokyo, Japan.
Sei NaitoDepartment of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan.ORCID https://orcid.org/0000-0002-6104-4344
Takashige AbeDepartment of Renal and Genitourinary Surgery, Hokkaido University Graduate School of Medicine, Hokkaido, Japan.ORCID https://orcid.org/0000-0002-5468-7632
Kojiro OhbaDepartment of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.ORCID https://orcid.org/0000-0003-2841-1998
Go KimuraDepartment of Urology, Nippon Medical School Hospital, Tokyo, Japan.
Shunta OnoderaOno Pharmaceutical Co. Ltd., Osaka, Japan.
Katsumi YamaguchiBristol Myers Squibb, Tokyo, Japan.
Hirotsugu UemuraDepartment of Urology, Kindai University Faculty of Medicine, Osaka, Japan.ORCID https://orcid.org/0000-0002-3665-9523

Funding

Bristol-Myers SquibbOno Pharmaceutical
6 · The paper itself

Abstract

objectivesJ-ENCORE is a multicenter prospective observational study in Japan involving advanced or metastatic renal cell carcinoma patients receiving nivolumab-plus-ipilimumab (NIVO+IPI) as first-line treatment. The minimum 1-year observation revealed the efficacy and safety of NIVO+IPI comparable to those in CheckMate 214, and evaluated patient characteristics across subgroups for response and early progression. This minimum 2-year observation focuses on the post-treatment status after NIVO+IPI discontinuation.

methodsThe objective response rate (ORR), response duration, progression-free survival (PFS), overall survival (OS), treatment-related adverse events (TRAEs), treatment-free status, and second-line treatment were evaluated.

resultsThe study included 274 patients (median age, 68 years; 24.8% aged ≥ 75 years; 15.7% had an Eastern Cooperative Oncology Group performance status ≥ 2; 58.0%, intermediate risk; 42.0%, poor risk) from 37 sites, with a median follow-up of 35.4 (range, 24.4-47.0) months. The ORR was 37.6%, with a median real-world duration of response at 17.1 months; 30.2% had real-world PFS ≥ 24 months, and the OS rate at 24 months was 67.2%. TRAEs of any grade, grade 3/4, and grade 5 occurred in 77.4%, 42.7%, and 1.1% of patients, respectively. Furthermore, 11.1% experienced late-onset TRAEs 28-100 days after discontinuation. For patients discontinuing NIVO+IPI due to adverse events, median treatment-free survival was 7.4 months; 34.9% had a treatment-free interval ≥ 12 months. Second-line treatment ORR was 22.0%, with cabozantinib as the most common choice.

conclusionsWe determined the long-term real-world effectiveness and safety of NIVO+IPI, providing beneficial information on post-treatment status.

trial registrationUMIN Clinical Trials Registry number: UMIN000036772; ClinicalTrials.gov identifier: NCT04043975.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Renal CellKidney NeoplasmsNivolumabAdultAgedAged, 80 and overFemaleHumansJapanMaleMiddle AgedProgression-Free SurvivalProspective StudiesTreatment OutcomeNivolumabipilimumabJapannivolumabprospective studyrenal cell carcinoma

Identifiers

PMID41292059
PMCPMC12835681

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.