Evidence map›Paper›PMID 40614118›Full record

Trial reportCancer2025

Administration of nivolumab plus ipilimumab: Infusion of the fixed-ratio combination versus sequential infusions in two randomized controlled trials of metastatic melanoma (CheckMate 742) and renal cell carcinoma (CheckMate 800).

Alexander M Menzies, Pamela Salman, Osvaldo Arén Frontera, David Pook, Christopher M Hocking, Yousef Zakharia, Howard Gurney, Craig Gedye, Jeffrey C Goh, Bijoy Telivala and 10 more

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase IIIClinical Trial, Phase II
In one paragraph

Trial report in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 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.

NCT02905266 phase3completednot on this map

Phase IIIb, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Previously Untreated Unresectable or Metastatic Melanoma

TypeinterventionalSponsorBristol-Myers SquibbRan2016 to 2019Enrolled106ConditionsMelanomaArmsNivolumab, Ipilimumab
NCT03029780 phase2completednot on this map

Phase II, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma

TypeinterventionalSponsorBristol-Myers SquibbRan2017 to 2021Enrolled104ConditionsRenal Cell CarcinomaArmsOpdivo, Yervoy
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. 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

20 authors.

Alexander M MenziesMelanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia.
Pamela SalmanFundación Arturo López Pérez, Santiago, Chile.
Osvaldo Arén FronteraCentro Investigación Clínica Bradford Hill, Santiago, Chile.
David PookCabrini Hospital, Malvern, Victoria, Australia.
Christopher M HockingLyell McEwin Hospital, Elizabeth Vale, South Australia, Australia.
Yousef ZakhariaUniversity of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.
Howard GurneyWestmead Hospital and Macquarie University, Sydney, New South Wales, Australia.
Craig GedyeCalvary Mater Newcastle, Waratah, New South Wales, Australia.
Jeffrey C GohRoyal Brisbane and Women's Hospital and Queensland University of Technology (QUT), Brisbane, Queensland, Australia.
Bijoy TelivalaCancer Specialists of North Florida, Jacksonville, Florida, USA.
Jean-Jacques GrobHôpital de la Timone, Marseille, France.
Céleste LebbéUniversité Paris Cité, INSERM U976, Dermato-Oncologie and CIC AP-HP Hôpital Saint Louis, Cancer Institute APHP, Nord-Université Paris Cité, Paris, France.ORCID https://orcid.org/0000-0002-5854-7290
Luis de la Cruz MerinoCancer Immunotherapy, Clinical Oncology Department, Biomedicine Institute of Seville (IBIS)/CSIC, University Hospital Virgen Macarena and School of Medicine, University of Seville, Seville, Spain.
Laurent MachetCentre Hospitalier Régional Universitaire de Tours, Université de Tours, Tours, France.
Eve-Marie NeidhardtCentre Léon Bérard, Lyon, France.
Anila QureshiBristol Myers Squibb, Princeton, New Jersey, USA.
Fareeda HoseinBristol Myers Squibb, Princeton, New Jersey, USA.ORCID https://orcid.org/0009-0006-1152-6595
Lora HamuroBristol Myers Squibb, Princeton, New Jersey, USA.
Burcin SimsekBristol Myers Squibb, Princeton, New Jersey, USA.
Asim AminLevine Cancer Institute, Atrium Health, Charlotte, North Carolina, USA.

Funding

Bristol Myers Squibb
6 · The paper itself

Abstract

backgroundImmune checkpoint inhibitors can be coadministered as a fixed-ratio combination (FRC) or administered as sequential infusions (ASI). Two randomized, open-label trials compared nivolumab + ipilimumab as a FRC versus ASI in patients with melanoma or renal cell carcinoma.

methodsCheckMate 742 was a Phase 3b study in patients with advanced or metastatic melanoma who received nivolumab 1 mg/kg and ipilimumab 3 mg/kg either concurrently as an FRC or sequentially as ASI every 3 weeks. CheckMate 800 was a Phase 2 study in patients with advanced or metastatic renal cell carcinoma who received nivolumab 3 mg/kg and ipilimumab 1 mg/kg either concurrently as an FRC or sequentially as ASI every 3 weeks. The primary endpoint was the incidence of adverse events (AEs) in the Broad Scope Medical Dictionary for Regulatory Activities (MedDRA) Anaphylactic Reaction Standardized MedDRA Queries (SMQ) occurring within 2 days after dosing. Secondary endpoints included incidence of AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ.

resultsThere was no clinically relevant difference in safety between FRC and ASI as measured by the primary endpoint in either study; odds ratio (95% CI) of 0.87 (0.30-2.49) and 1.0 (0.30-3.39) for CheckMate 742 and CheckMate 800, respectively. No AEs were reported in the Narrow Scope MedDRA Anaphylactic Reaction SMQ in either study. One death from drug toxicity occurred in CheckMate 742.

conclusionsBoth studies met their primary endpoint. The safety profiles of nivolumab + ipilimumab as FRC or ASI were acceptable and manageable. TRIAL REGISTRATION NUMBERS: NCT02905266 and NCT03029780 for CheckMate 742 and CheckMate 800, respectively.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Renal CellIpilimumabKidney NeoplasmsMelanomaNivolumabAdultAgedAged, 80 and overFemaleHumansInfusions, IntravenousMaleMiddle AgedIpilimumabNivolumabimmune checkpoint inhibitorsipilimumabmelanomanivolumabrenal cell carcinoma

Identifiers

PMID40614118
PMCPMC12229271

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.