Evidence map›Paper›PMID 36512738›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

Nivolumab Plus Cabozantinib With or Without Ipilimumab for Advanced Hepatocellular Carcinoma: Results From Cohort 6 of the CheckMate 040 Trial.

Thomas Yau, Vittorina Zagonel, Armando Santoro, Mirelis Acosta-Rivera, Su Pin Choo, Ana Matilla, Aiwu Ruth He, Antonio Cubillo Gracian, Anthony B El-Khoueiry, Bruno Sangro and 9 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 2 pooled it
8.0field-weighted citation impact, top 2% 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.

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

48 citing papers in PubMed, 2 syntheses or guidelines pooled it, 65 citations in OpenAlex.

  1. Pooled it
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  5. Review
  6. Article
  7. Targeting Tumor-Associated Macrophages and Cancer-Associated Fibroblasts to Overcome Therapeutic Resistance in Hepatocellular Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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  12. [Chinese expert consensus on the use of standardized second-line drugs for primary hepatocellular carcinoma].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2026
    Article
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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

19 authors at 17 institutions in 6 countries.

Thomas YauThe University of Hong Kong, Hong Kong, China.ORCID 0000-0002-7114-0305
Vittorina ZagonelOncology Unit 1, Veneto Institute of Oncology, IOV-IRCCS, Padova, Italy.
Armando SantoroDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy.ORCID 0000-0003-1709-9492
Mirelis Acosta-RiveraFundacion de Investigación, San Juan, Puerto Rico.
Su Pin ChooNational Cancer Center and Curie Oncology, Singapore.ORCID 0000-0002-8925-3922
Ana MatillaServicio de Digestivo, Hospital General Universitario Gregorio Marañón, Madrid, Spain.ORCID 0000-0003-3162-4812
Aiwu Ruth HeGeorgetown University Hospital, Washington, DC.ORCID 0000-0002-2104-0816
Antonio Cubillo GracianHospital HM Universitario Sanchinarro, Centro Integral Oncológico Clara Campal (HM-CIOCC), Madrid, Spain.
Anthony B El-KhoueiryUSC Norris Comprehensive Cancer Center, Los Angeles, CA.ORCID 0000-0002-9053-3841
Bruno SangroClinica Universidad de Navarra and CIBEREHD, Pamplona, Spain.ORCID 0000-0002-4177-6417
Tarek E EldawySacred Heart Health Systems, Pensacola, FL.
Jordi BruixBCLC Group, Liver Unit, Hospital Clínic-IDIBAPS, University of Barcelona, CIBEREHD, Barcelona, Spain.
Giovanni Luca FrassinetiIRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori," Meldola, Italy.
Gina M VaccaroProvidence Cancer Institute, Portland, OR.ORCID 0000-0003-3934-0806
Marina TschaikaBristol Myers Squibb, Princeton, NJ.
Christian ScheffoldExelixis, Inc, Alameda, CA.
Petra KoopmansBristol Myers Squibb, Princeton, NJ.
Jaclyn NeelyBristol Myers Squibb, Princeton, NJ.
Fabio PiscagliaDivision of Internal Medicine, Hepatobiliary and Immunoallergic Diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Bristol-Myers Squibb (United States) · USAzienda USL di Bologna · ITCentro de Investigación Biomédica en Red · ESConsorci Institut D'Investigacions Biomediques August Pi I Sunyer · ESExelixis (United States) · USGeorgetown University · USHospital General Universitario Gregorio Marañón · ESHospital Universitario HM Sanchinarro · ESHumanitas University · ITIstituto Oncologico Veneto · ITIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITNational Cancer Centre Singapore · SGProvidence Portland Medical Center · USPuerto Rico Community Foundation · PRSacred Heart Health System · USUniversity of Hong Kong · HKUSC Norris Comprehensive Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo investigate the safety and efficacy of nivolumab plus cabozantinib with or without ipilimumab in patients with advanced hepatocellular carcinoma.

methodsIn cohort 6 of the multicohort, open-label, phase I/II CheckMate 040 study, patients who were treatment-naive, sorafenib-intolerant, or had progressed on sorafenib were randomly assigned 1:1 to nivolumab 240 mg once every 2 weeks plus cabozantinib 40 mg once daily (doublet arm); or nivolumab 3 mg/kg every 2 weeks plus cabozantinib 40 mg once daily with ipilimumab 1 mg/kg once every 6 weeks (triplet arm). Primary objectives were safety and tolerability, objective response rate, and duration of response by investigator assessment per RECIST v1.1. Secondary objectives included progression-free survival (by blinded independent central review) and overall survival.

resultsSeventy-one patients were randomly assigned: 36 to the doublet arm and 35 to the triplet arm. After 32.0-month median follow-up, objective response rate (95% CI) was 17% (6 to 33) and 29% (15 to 46) in the doublet and triplet arms, respectively. Median (95% CI) duration of response was 8.3 (6.9 to not estimable) months in the doublet arm and not reached (0.0 to not estimable) in the triplet arm. Median progression-free survival was 5.1 and 4.3 months, and median overall survival was 20.2 and 22.1 months for the doublet and triplet arms, respectively. Grade 3-4 treatment-related adverse events occurred in 50% and 74% of patients and treatment-related adverse events leading to discontinuation were reported for 11% and 23% in the doublet and triplet arms, respectively. There were no treatment-related deaths in either arm.

conclusionNivolumab plus cabozantinib with or without ipilimumab showed encouraging preliminary antitumor activity and had consistent safety profiles with those established for the individual drugs in patients with advanced hepatocellular carcinoma.

Indexed as

Carcinoma, HepatocellularLiver NeoplasmsAnilidesAntineoplastic Combined Chemotherapy ProtocolsHumansIpilimumabNivolumabPyridinesSorafenibAnilidescabozantinibIpilimumabNivolumabPyridinesSorafenib

Identifiers

PMID36512738
PMCPMC10022845
OpenAlexW4312018381

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.