Evidence map›Paper›PMID 35383908›Full record

Trial reportCancer2022

Conditional survival and long-term efficacy with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma.

Robert J Motzer, David F McDermott, Bernard Escudier, Mauricio Burotto, Toni K Choueiri, Hans J Hammers, Philippe Barthélémy, Elizabeth R Plimack, Camillo Porta, Saby George and 15 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02231749 (A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Sunitinib Monotherapy in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma), which is not on this map. Cited by 153 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
153citing papers in PubMed, 11 pooled it
38.6field-weighted citation impact, top 1% of its field
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.

NCT02231749 phase3completednot on this map

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

TypeinterventionalSponsorBristol-Myers SquibbRan2014 to 2025Enrolled1,096ConditionsAdvanced Renal Cell Carcinoma, Metastatic Renal Cell CarcinomaArmsNivolumab, Ipilimumab, Sunitinib
3 · Its place in the literature

Who cites it

153 citing papers in PubMed, 11 syntheses or guidelines pooled it, 259 citations in OpenAlex.

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  4. Treatments for renal cell carcinoma: NICE Pilot Treatment Pathways Appraisal.Health technology assessment (Winchester, England) · 2026
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  15. Neoadjuvant Nivolumab Plus Ipilimumab Versus Chemotherapy in Resectable Lung Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
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93 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 20 institutions in 11 countries.

Robert J MotzerDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0001-6925-2327
David F McDermottDivision of Medical Oncology, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, Massachusetts.
Bernard EscudierDepartment of Medical Oncology, Gustave Roussy, Villejuif, France.
Mauricio BurottoBradford Hill Clinical Research Center, Santiago, Chile.
Toni K ChoueiriDepartment of Medical Oncology, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts.ORCID 0000-0002-9201-3217
Hans J HammersDepartment of Medical Oncology, University of Texas Southwestern Kidney Cancer Program, Dallas, Texas.
Philippe BarthélémyMedical Oncology, Strasbourg European Cancer Institute, Strasbourg, France.
Elizabeth R PlimackDepartment of Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.
Camillo PortaDepartment of Internal Medicine, University of Pavia, Pavia, Italy.
Saby GeorgeDepartment of Medicine, Roswell Park Cancer Institute, Buffalo, New York.
Thomas PowlesDepartment of Genitourinary Oncology, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Center, Queen Mary University of London, Royal Free National Health Service Trust, London, United Kingdom.
Frede DonskovDepartment of Oncology, Aarhus University Hospital, Aarhus, Denmark.
Howard GurneyDepartment of Medical Oncology, Westmead Hospital and Macquarie University, Sydney, New South Wales, Australia.
Christian K KollmannsbergerDepartment of Medicine, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.
Marc-Oliver GrimmDepartment of Urology, Jena University Hospital, Jena, Germany.
Carlos BarriosOncology Research Unit, Saint Luke Hospital, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.
Yoshihiko TomitaDepartments of Urology and Molecular Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
Daniel CastellanoMedical Oncology Department, October 12th University Hospital, Cancer Network Biomedical Research Center, Madrid, Spain.
Viktor GrünwaldInterdisciplinary Genitourinary Oncology, West German Cancer Center Clinic for Internal Medicine and Clinic for Urology, University Hospital Essen, Essen, Germany.
Brian I RiniDivision of Hematology and Oncology, Vanderbilt University Medical Center, Nashville, Tennessee.
M Brent McHenryDepartment of Biostatistics, Bristol Myers Squibb, Princeton, New Jersey.
Chung-Wei LeeDepartment of Clinical Trials, Bristol Myers Squibb, Princeton, New Jersey.
Jennifer McCarthyDepartment of Clinical Scientists, Bristol Myers Squibb, Princeton, New Jersey.
Flavia EjzykowiczDepartment of Health Economics and Outcomes Research, Bristol Myers Squibb, Princeton, New Jersey.
Nizar M TannirDepartment of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Bristol-Myers Squibb (United States) · USAarhus University Hospital · DKBC Cancer Agency · CABeth Israel Deaconess Medical Center · USBrigham and Women's Hospital · USCentre for Biomedical Network Research on Rare Diseases · ESFox Chase Cancer Center · USInstitut de Cancérologie Strasbourg · FRInstitut Gustave Roussy · FRJena University Hospital · DEMemorial Sloan Kettering Cancer Center · USNational Health Service · GBNiigata University · JPPontifícia Universidade Católica do Rio Grande do Sul · BRRoswell Park Comprehensive Cancer Center · USThe University of Texas MD Anderson Cancer Center · USThe University of Texas Southwestern Medical Center · USUniversity of Pavia · ITVanderbilt University Medical Center · USWestmead Hospital · AU

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundConditional survival estimates provide critical prognostic information for patients with advanced renal cell carcinoma (aRCC). Efficacy, safety, and conditional survival outcomes were assessed in CheckMate 214 (ClinicalTrials.gov identifier NCT02231749) with a minimum follow-up of 5 years.

methodsPatients with untreated aRCC were randomized to receive nivolumab (NIVO) (3 mg/kg) plus ipilimumab (IPI) (1 mg/kg) every 3 weeks for 4 cycles, then either NIVO monotherapy or sunitinib (SUN) (50 mg) daily (four 6-week cycles). Efficacy was assessed in intent-to-treat, International Metastatic Renal Cell Carcinoma Database Consortium intermediate-risk/poor-risk, and favorable-risk populations. Conditional survival outcomes (the probability of remaining alive, progression free, or in response 2 years beyond a specified landmark) were analyzed.

resultsThe median follow-up was 67.7 months; overall survival (median, 55.7 vs 38.4 months; hazard ratio, 0.72), progression-free survival (median, 12.3 vs 12.3 months; hazard ratio, 0.86), and objective response (39.3% vs 32.4%) benefits were maintained with NIVO+IPI versus SUN, respectively, in intent-to-treat patients (N = 550 vs 546). Point estimates for 2-year conditional overall survival beyond the 3-year landmark were higher with NIVO+IPI versus SUN (intent-to-treat patients, 81% vs 72%; intermediate-risk/poor-risk patients, 79% vs 72%; favorable-risk patients, 85% vs 72%). Conditional progression-free survival and response point estimates were also higher beyond 3 years with NIVO+IPI. Point estimates for conditional overall survival were higher or remained steady at each subsequent year of survival with NIVO+IPI in patients stratified by tumor programmed death ligand 1 expression, grade ≥3 immune-mediated adverse event experience, body mass index, and age.

conclusionsDurable clinical benefits were observed with NIVO+IPI versus SUN at 5 years, the longest phase 3 follow-up for a first-line checkpoint inhibitor-based combination in patients with aRCC. Conditional estimates indicate that most patients who remained alive or in response with NIVO+IPI at 3 years remained so at 5 years.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansIpilimumabMaleNivolumabSunitinibIpilimumabNivolumabSunitinibadvanced renal cell carcinomaCheckMate 214dual checkpoint inhibitiondurable responselong-term follow-upnivolumab plus ipilimumabphase 3

Identifiers

PMID35383908
PMCPMC9543316
OpenAlexW4225464106

What OpenQuestion holds

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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.