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)

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dc.contributor.authorMenzies, A.M.
dc.contributor.authorSalman, P.
dc.contributor.authorFrontera, O.A.
dc.contributor.authorPook, D.
dc.contributor.authorHocking, C.M.
dc.contributor.authorZakharia, Y.
dc.contributor.authorGurney, H.
dc.contributor.authorGedye, C.
dc.contributor.authorGoh, J.C.
dc.contributor.authorTelivala, B.
dc.contributor.authorGrob, J.J.
dc.contributor.authorLebbé, C.
dc.contributor.authorde la Cruz Merino, L.
dc.contributor.authorMachet, L.
dc.contributor.authorNeidhardt, E.M.
dc.contributor.authorQureshi, A.
dc.contributor.authorHosein, F.
dc.contributor.authorHamuro, L.
dc.contributor.authorSimsek, B.
dc.contributor.authorAmin, A.
dc.date.issued2025
dc.description.abstractBackground: Immune checkpoint inhibitors can be coadministered as a fixed‐ratio combination (FRC) or administered as sequential infusions (ASI). Two randomized, open‐label trials compared nivolumab þ ipilimumab as a FRC versus ASI in patients with melanoma or renal cell carcinoma. Methods: CheckMate 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. Results: There 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 Check- Mate 742. Conclusions: Both studies met their primary endpoint. The safety profiles of nivolumab þ ipilimumab as FRC or ASI were acceptable and manageable. Trial registration numbers: NCT02905266 and NCT03029780 for CheckMate 742 and CheckMate 800, respectively.
dc.description.statementofresponsibilityAlexander M. Menzies, Pamela Salman, Osvaldo Arén Frontera, David Pook, Christopher M. Hocking, Yousef Zakharia, Howard Gurney, Craig Gedye MBBS, Jeffrey C. Goh, Bijoy Telivala, Jean, Jacques Grob, Céleste Lebbé, Luis de la Cruz Merino, Laurent Machet, Eve, Marie Neidhardt, Anila Qureshi, Fareeda Hosein, Lora Hamuro, Burcin Simsek, Asim Amin
dc.identifier.citationCancer, 2025; 131(14):35962-1-35962-11
dc.identifier.doi10.1002/cncr.35962
dc.identifier.issn0008-543X
dc.identifier.issn1097-0142
dc.identifier.urihttps://hdl.handle.net/2440/147680
dc.language.isoen
dc.publisherWiley
dc.relation.grantNHMRC
dc.rights© 2025 The Author(s). Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
dc.source.urihttps://doi.org/10.1002/cncr.35962
dc.subjectimmune checkpoint inhibitors; nivolumab; ipilimumab; melanoma; renal cell carcinoma
dc.subject.meshHumans
dc.subject.meshMelanoma
dc.subject.meshCarcinoma, Renal Cell
dc.subject.meshKidney Neoplasms
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.subject.meshInfusions, Intravenous
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshAged, 80 and over
dc.subject.meshMiddle Aged
dc.subject.meshFemale
dc.subject.meshMale
dc.subject.meshIpilimumab
dc.subject.meshNivolumab
dc.titleAdministration 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)
dc.typeJournal article
pubs.publication-statusPublished

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