Summary of Research: Adjuvant Nivolumab Plus Ipilimumab Versus Placebo for Localized Renal Cell Carcinoma After Nephrectomy (CheckMate 914): A Double-Blind, Randomized, Phase 3 Trial

Robert J Motzer; Paul Russo; Viktor Grünwald; Yoshihiko Tomita; Bogdan Zurawski; Omi Parikh; Sebastiano Buti; Philippe Barthélémy; Jeffrey C Goh; Dingwei Ye; Alejo Lingua; Jean-Baptiste Lattouf; Laurence Albigès; Saby George; Brian Shuch; Jeffrey Sosman; Michael Staehler; Sergio Vázquez Estévez; Burcin Simsek; Julia Spiridigliozzi; Aleksander Chudnovsky; Axel Bex

doi:10.1007/s11523-023-00987-1

Summary of Research: Adjuvant Nivolumab Plus Ipilimumab Versus Placebo for Localized Renal Cell Carcinoma After Nephrectomy (CheckMate 914): A Double-Blind, Randomized, Phase 3 Trial

Target Oncol. 2023 Sep;18(5):639-641. doi: 10.1007/s11523-023-00987-1. Epub 2023 Sep 2.

Authors

Robert J Motzer¹, Paul Russo², Viktor Grünwald³, Yoshihiko Tomita⁴, Bogdan Zurawski⁵, Omi Parikh⁶, Sebastiano Buti⁷, Philippe Barthélémy⁸, Jeffrey C Goh⁹, Dingwei Ye¹⁰, Alejo Lingua¹¹, Jean-Baptiste Lattouf¹², Laurence Albigès¹³, Saby George¹⁴, Brian Shuch¹⁵, Jeffrey Sosman¹⁶, Michael Staehler¹⁷, Sergio Vázquez Estévez¹⁸, Burcin Simsek¹⁹, Julia Spiridigliozzi²⁰, Aleksander Chudnovsky^{21

22}, Axel Bex^{23

24

25}

Affiliations

¹ Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, 10021, USA. motzerr@mskcc.org.
² Department of Surgery, Urology Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
³ Clinic for Urology, Clinic for Medical Oncology, University Hospital Essen, Essen, Germany.
⁴ Department of Urology and Department of Molecular Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
⁵ Department of Outpatient Chemotherapy, Prof. Franciszek Łukaszczyk Oncology Centre, Bydgoszcz, Poland.
⁶ Rosemere Cancer Centre, Lancashire Teaching Hospitals NHS Trust, Preston, UK.
⁷ Department of Medicine and Surgery, University of Parma, Parma, Italy.
⁸ Medical Oncology Unit, Institut de Cancérologie Strasbourg Europe, Strasbourg, France.
⁹ ICON Research, South Brisbane, and Queensland University of Technology, Brisbane, QLD, Australia.
¹⁰ Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China.
¹¹ Instituto Médico Río Cuarto, Río Cuarto, Argentina.
¹² Department of Surgery-Urology, CHUM-Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.
¹³ Department of Cancer Medicine, Gustave Roussy, Villejuif, France.
¹⁴ Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
¹⁵ University of California, Los Angeles, Los Angeles, CA, USA.
¹⁶ Northwestern University Medical Center, Chicago, IL, USA.
¹⁷ Interdisciplinary Centre on Renal Tumors, University of Munich, Munich, Germany.
¹⁸ Hospital Universitario Lucus Augusti (HULA), EOXI de Lugo, Cervo e Monforte, Lugo, Spain.
¹⁹ Department of Global Biometrics and Data Science, Bristol Myers Squibb, Princeton, NJ, USA.
²⁰ Department of Oncology Late Clinical Global Drug Development, Bristol Myers Squibb, Princeton, NJ, USA.
²¹ Department of Oncology, Clinical Development, Bristol Myers Squibb, Princeton, NJ, USA.
²² Takeda Pharmaceuticals, Boston, MA, USA.
²³ Department of Urology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
²⁴ Department of Urology, The Royal Free London NHS Foundation Trust, London, UK.
²⁵ Division of Surgery and Interventional Science, University College London, London, UK.

Abstract

This is a summary of a research article reporting Part A of the CheckMate 914 study (NCT03138512; EudraCT 2016-004502-34). Following surgery to remove renal cell carcinoma (RCC), people with a high risk of the cancer returning received nivolumab plus ipilimumab (adjuvant therapy) or placebo to see if this risk was reduced. The results of this study showed that the risk of RCC returning or death was not changed with adjuvant nivolumab plus ipilimumab treatment compared with placebo. In addition, people treated with nivolumab plus ipilimumab had more side effects compared with people treated with placebo (89% versus 57%).

Publication types

Randomized Controlled Trial
Clinical Trial, Phase III
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Carcinoma, Renal Cell* / drug therapy
Humans
Ipilimumab / pharmacology
Ipilimumab / therapeutic use
Kidney Neoplasms* / drug therapy
Kidney Neoplasms* / surgery
Nephrectomy
Nivolumab / pharmacology
Nivolumab / therapeutic use

Substances

Ipilimumab
Nivolumab

Grants and funding

P30 CA008748/CA/NCI NIH HHS/United States