Evidence map›Paper›PMID 41739193›Full record

ArticleCancer immunology, immunotherapy : CII2026

A real-world comparison of nivolumab plus cabozantinib and pembrolizumab plus lenvatinib focusing on safety outcomes in metastatic renal cell carcinoma: results from the JK-FOOT consortium.

Takafumi Yanagisawa, Keiichiro Mori, Tatsushi Kawada, Satoshi Katayama, Takuya Tsujino, Ryoichi Maenosono, Shingo Toyoda, Takuhisa Nukaya, Hirofumi Morinaka, Keita Tamura and 12 more

Abstract readComparative StudyMulticenter Study
In one paragraph

Article in Cancer immunology, immunotherapy : CII, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
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

22 authors.

Takafumi Yanagisawa *Department of Urology, The Jikei University School of Medicine, Nishi-Shimbashi, Japan. t.yanagisawa.jikei@gmail.com.
Keiichiro Mori *Department of Urology, The Jikei University School of Medicine, Nishi-Shimbashi, Japan.
Tatsushi KawadaDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Satoshi KatayamaDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Takuya TsujinoDepartment of Urology, Osaka Medical and Pharmaceutical University, Takatsuki, Japan.
Ryoichi MaenosonoDepartment of Urology, Osaka Medical and Pharmaceutical University, Takatsuki, Japan.
Shingo ToyodaDepartment of Urology, Faculty of Medicine, Kindai University, Higashi-osaka, Japan.
Takuhisa NukayaDepartment of Urology, Fujita-Health University School of Medicine, Toyoake, Japan.
Hirofumi MorinakaDepartment of Urology, Kawasaki Medical School, Kurashiki, Japan.
Keita TamuraDepartment of Urology, Hamamatsu Medical University, Hamamatsu, Japan.
Wataru FukuokayaDepartment of Urology, The Jikei University School of Medicine, Nishi-Shimbashi, Japan.
Fumihiko UrabeDepartment of Urology, The Jikei University School of Medicine, Nishi-Shimbashi, Japan.
Masaya MurakamiDepartment of Urology, The Jikei University School of Medicine, Nishi-Shimbashi, Japan.
Kensuke BekkuDepartment of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
Kiyoshi TakaharaDepartment of Urology, Fujita-Health University School of Medicine, Toyoake, Japan.
Kazutoshi FujitaDepartment of Urology, Faculty of Medicine, Kindai University, Higashi-osaka, Japan.
Haruhito AzumaDepartment of Urology, Osaka Medical and Pharmaceutical University, Takatsuki, Japan.
Motoo ArakiDepartment of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
Teruo InamotoDepartment of Urology, Hamamatsu Medical University, Hamamatsu, Japan.
Kazumasa KomuraDepartment of Urology, Kawasaki Medical School, Kurashiki, Japan.
Takahiro KimuraDepartment of Urology, The Jikei University School of Medicine, Nishi-Shimbashi, Japan.
JK-FOOT study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeImmune checkpoint inhibitor (ICI)-based combination therapy is a standard first-line treatment for metastatic renal cell carcinoma (mRCC), with combinations such as nivolumab plus cabozantinib (Nivo + Cabo) and pembrolizumab plus lenvatinib (Pem + Len) demonstrating favorable oncologic outcomes. However, no direct comparisons between these two regimens have been conducted. This study aimed to compare the safety and oncologic outcomes of Nivo + Cabo and Pem + Len in patients with mRCC.

methodsThis retrospective study included 185 patients with mRCC treated with Nivo + Cabo (n = 81) or Pem + Len (n = 104) between January 2018 and June 2025 across multiple institutions. The primary outcome was a comparison of treatment-related adverse events (TrAEs). Oncologic outcomes, including objective response rate (ORR), progression-free survival (PFS), cancer-specific survival (CSS), and overall survival (OS), were compared using one-to-one propensity score matching.

resultsAny-grade TrAEs occurred in 90% of patients in the Nivo + Cabo group and 92% in the Pem + Len group (p = 0.6). Severe TrAEs (grade ≥ 3) were more frequent in the Pem + Len group (44%) than in the Nivo + Cabo group (30%, p = 0.048). Tyrosine kinase inhibitor dose reduction and treatment discontinuation rates were similar between groups. In the matched cohort (Nivo + Cabo: n = 74; Pem + Len: n = 74), ORRs were comparable (66% vs. 71%, p = 0.6). With a median follow-up of 17 months, no significant differences were observed in PFS (p = 0.4), CSS (p = 0.9), or OS (p = 0.5).

conclusionsNivo + Cabo and Pem + Len demonstrated similar oncologic efficacy as first-line treatments for mRCC. However, Pem + Len was associated with more severe TrAEs. Careful toxicity management and shared decision-making are essential when selecting ICI-based combinations.

Indexed as

AnilidesAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Renal CellKidney NeoplasmsNivolumabPyridinesQuinolinesAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedNeoplasm MetastasisAnilidesAntibodies, Monoclonal, HumanizedcabozantiniblenvatinibNivolumabpembrolizumabPhenylurea CompoundsPyridinesQuinolinesCabozantinibImmune checkpoint inhibitorLenvatinibMetastatic renal cell carcinomaNivolumabPembrolizumab

Identifiers

PMID41739193
PMCPMC12936286

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Registered trials

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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.