LITESPARK-012: pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab for advanced renal cell carcinoma

Toni K. Choueiri; Thomas Powles; Martin H. Voss; Elizabeth R. Plimack; Howard Gurney; Yue Song; Rodolfo F. Perini; Karla Rodriguez-Lopez; Brian I. Rini

doi:10.2217/fon-2023-0283

LITESPARK-012: pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab for advanced renal cell carcinoma

Toni K. Choueiri, Thomas Powles, Martin H. Voss, Elizabeth R. Plimack, Howard Gurney, Yue Song, Rodolfo F. Perini, Karla Rodriguez-Lopez, Brian I. Rini

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Abstract

Combination treatment with immunotherapy agents and/or vascular endothelial growth factor tyrosine kinase inhibitors are a standard of care for patients with advanced clear cell renal cell carcinoma (ccRCC). Novel therapeutic combinations that include the hypoxia-inducible factor 2α inhibitor belzutifan and the cytotoxic T-lymphocyte-associated protein 4 inhibitor quavonlimab are being investigated for their potential to further improve patient outcomes. This protocol describes the rationale and design of the randomized, phase III LITESPARK-012 study, which will evaluate the efficacy and safety of pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab as first-line treatment for advanced ccRCC. Results from this study may support triplet combination therapies as a potential new standard of care for advanced ccRCC. Clinical trial registry: NCT04736706 (ClinicalTrials.gov).

Original language	English
Pages (from-to)	2631-2640
Number of pages	10
Journal	Future Oncology
Volume	19
Issue number	40
Early online date	Oct 2023
DOIs	https://doi.org/10.2217/fon-2023-0283
Publication status	Published - 1 Dec 2023

Bibliographical note

Copyright Merck & Co., Inc. 2023. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

clear cell renal cell carcinoma
CTLA-4 inhibitor
HIF-2α inhibitor
immune checkpoint inhibitor
PD-1/L1 inhibitor
VEGFR-TKI

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10.2217/fon-2023-0283Licence: CC BY-NC-ND

Publisher version (open access)Final published version, 1.37 MBLicence: CC BY-NC-ND

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title = "LITESPARK-012: pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab for advanced renal cell carcinoma",

abstract = "Combination treatment with immunotherapy agents and/or vascular endothelial growth factor tyrosine kinase inhibitors are a standard of care for patients with advanced clear cell renal cell carcinoma (ccRCC). Novel therapeutic combinations that include the hypoxia-inducible factor 2α inhibitor belzutifan and the cytotoxic T-lymphocyte-associated protein 4 inhibitor quavonlimab are being investigated for their potential to further improve patient outcomes. This protocol describes the rationale and design of the randomized, phase III LITESPARK-012 study, which will evaluate the efficacy and safety of pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab as first-line treatment for advanced ccRCC. Results from this study may support triplet combination therapies as a potential new standard of care for advanced ccRCC. Clinical trial registry: NCT04736706 (ClinicalTrials.gov).",

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note = "Copyright Merck & Co., Inc. 2023. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.",

year = "2023",

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doi = "10.2217/fon-2023-0283",

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AU - Powles, Thomas

AU - Voss, Martin H.

AU - Plimack, Elizabeth R.

AU - Gurney, Howard

AU - Song, Yue

AU - Perini, Rodolfo F.

AU - Rodriguez-Lopez, Karla

AU - Rini, Brian I.

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LITESPARK-012: pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab for advanced renal cell carcinoma

Abstract

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