Evidence map›Paper›PMID 40998092›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2026

Final analysis of nivolumab plus cabozantinib for advanced renal cell carcinoma from the randomized phase III CheckMate 9ER trial.

R J Motzer, B Escudier, M Burotto, T Powles, A B Apolo, M T Bourlon, A Y Shah, C Porta, C Suárez, C H Barrios and 11 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03141177 (A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma), which is not on this map. Cited by 24 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 3 pooled it
–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.

NCT03141177 phase3completednot on this map

A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

TypeinterventionalSponsorBristol-Myers SquibbRan2017 to 2026Enrolled701ConditionsRenal Cell CarcinomaArmsNivolumab, Cabozantinib, Sunitinib, Ipilimumab
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Review
  6. Progress in management of advanced clear-cell renal cell carcinoma.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  7. Observational
  8. Article
  9. Article
  10. Review
  11. The clinical landscape of HIF2α inhibitors in oncology.Nature reviews. Clinical oncology · 2026
    Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

R J MotzerDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA. Electronic address: motzerr@mskcc.org.
B EscudierDepartment of Medical Oncology, Gustave Roussy, Villejuif, France.
M BurottoBradford Hill Clinical Research Center, Santiago, Chile.
T PowlesDepartment of Genitourinary Oncology, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, Royal Free National Health Service Trust, London, UK.
A B ApoloGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, USA.
M T BourlonDepartment of Hemato-Oncology, Urologic Oncology Clinic, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
A Y ShahDepartment of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, USA.
C PortaInterdisciplinary Department of Medicine, University of Bari 'Aldo Moro', Bari, Italy.
C SuárezDepartment of Medical Oncology, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
C H BarriosCentro de Pesquisa em Oncologia, Hospital São Lucas, PUCRS, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.
M RichardetFundación Richardet Longo, Instituto Oncológico de Córdoba, Córdoba, Argentina.
H GurneyDepartment of Clinical Medicine, Westmead Hospital and Macquarie University, Westmead and Sydney, Australia.
E R KesslerThe Division of Medical Oncology, Department of Internal Medicine, University of Colorado School of Medicine, Aurora, USA.
Y TomitaDepartment of Urology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan; Department of Molecular Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
J BedkeDepartment of Urology and Transplantations Surgery, Eva Mayr-Stihl Cancer Center, Klinikum Stuttgart, Stuttgart, Germany.
C ScheffoldDepartment of Clinical Development, Exelixis, Inc., Alameda, USA.
M AskelsonDepartment of Global Biometrics and Data Sciences, Bristol Myers Squibb, Princeton, USA.
J PanzicaDepartment of Late Clinical Science Oncology, Bristol Myers Squibb, Princeton, USA.
J ZhangDepartment of Clinical Research, Bristol Myers Squibb, Princeton, USA.
M van Kooten LosioDepartment of Oncology Late Clinical Development, Bristol Myers Squibb, Boudry, Switzerland.
T K ChoueiriDepartment of Medical Oncology, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, USA; Harvard Medical School, Boston, USA. Electronic address: Toni_Choueiri@dfci.harvard.edu.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
VectorP30CA006516 · NCI · DANA-FARBER CANCER INSTITUTE · PI Irene M. Ghobrial · 1985 to 2026
$330.6M
Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DIANE BODURKA · 1985 to 2026
$290.8M
Treating the P13-Kinase/AKTP50CA101942 · NCI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI David McDermott · 2003 to 2026
$53.4M
NCI NIH HHS P30 CA006516NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA016672NCI NIH HHS P50 CA101942
6 · The paper itself

Abstract

backgroundNivolumab plus cabozantinib (NIVO+CABO) showed significant benefits over sunitinib (SUN) in progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) for previously untreated advanced renal cell carcinoma (RCC) in the phase III CheckMate 9ER trial (NCT03141177). We report final, updated efficacy and safety results with median follow-up of 5.6 years. PATIENTS AND

methodsPatients with advanced RCC were randomized to first-line NIVO 240 mg intravenously every 2 weeks plus CABO 40 mg p.o. o.d. or SUN 50 mg p.o. o.d. (4 weeks each 6-week cycle) until disease progression or unacceptable toxicity (maximum 2 years of NIVO). The primary endpoint was PFS per RECIST v1.1 by blinded independent central review (BICR). Secondary endpoints included OS, ORR per RECIST v1.1 by BICR, and safety.

resultsMedian (range) follow-up was 5.6 years [67.6 (60.2-80.2) months]. In intent-to-treat patients (NIVO+CABO, n = 323; SUN, n = 328), PFS favored NIVO+CABO versus SUN [hazard ratio (HR) 0.58, 95% confidence interval (CI) 0.49-0.70]. Median PFS was 16.4 versus 8.3 months, respectively; 60-month PFS rates were 13.6% versus 3.6%. OS favored NIVO+CABO versus SUN (HR 0.79, 95% CI 0.65-0.96). Median OS was 46.5 versus 35.5 months, respectively; 60-month OS rates were 40.9% versus 35.4%. ORR was greater with NIVO+CABO versus SUN (55.7% versus 27.4%; complete response 13.9% versus 4.6%). The probability of remaining in response through 60 months with NIVO+CABO versus SUN was 22.0% versus 10.0%. In all treated patients (n = 320 each arm), any-grade (grade 3-4) treatment-related adverse events occurred in 97.5% (67.8%) versus 93.1% (55.0%) with NIVO+CABO versus SUN, respectively. No new deaths due to study drug toxicity occurred since the 32.9-month median follow-up.

conclusionsLong-term efficacy benefit was observed with NIVO+CABO over SUN in this final follow-up from CheckMate 9ER and safety was consistent with previous reports. These results reaffirm NIVO+CABO as a standard of care for previously untreated advanced RCC.

Indexed as

AnilidesAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Renal CellKidney NeoplasmsAdultAgedAged, 80 and overFemaleFollow-Up StudiesHumansMaleMiddle AgedNivolumabProgression-Free SurvivalPyridinesAnilidescabozantinibNivolumabPyridinescabozantinibimmunotherapynivolumabphase IIIpreviously untreated advanced renal cell carcinoma

Identifiers

PMID40998092
PMCPMC12522107

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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.