Adjuvant Nivolumab for Localized Renal Cell Carcinoma at High Risk of Recurrence After Nephrectomy: Part B of the Randomized, Placebo-Controlled, Phase III CheckMate 914 Trial
Uložené v:
| Názov: | Adjuvant Nivolumab for Localized Renal Cell Carcinoma at High Risk of Recurrence After Nephrectomy: Part B of the Randomized, Placebo-Controlled, Phase III CheckMate 914 Trial |
|---|---|
| Autori: | Robert J. Motzer, Axel Bex, Paul Russo, Yoshihiko Tomita, Hernan Javier Cutuli, Carlos Rojas, Marine Gross-Goupil, Giovanni Schinzari, Bohuslav Melichar, Philippe Barthélémy, Abraham Ruiz Garcia, Jeffrey Sosman, Marc-Oliver Grimm, Jeffrey C. Goh, Cristina Suarez, Christian K. Kollmannsberger, Suresh G. Nair, Brian M. Shuch, Jian Huang, Burcin Simsek, Julia Spiridigliozzi, Chung-Wei Lee, Maximiliano van Kooten Losio, Viktor Grünwald |
| Prispievatelia: | Institut Català de la Salut, [Motzer RJ] Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY. [Bex A] Netherlands Cancer Institute, Amsterdam, the Netherlands. University College London, London, United Kingdom. [Russo P] Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY. [Tomita Y] Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan. [Cutuli HJ] Hospital Sirio Libanés, Buenos Aires, Argentina. [Rojas C] Bradford Hill, Santiago, Chile. [Suarez C] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus |
| Zdroj: | J Clin Oncol Scientia Scientia. Dipòsit d'Informació Digital del Departament de Salut instname |
| Informácie o vydavateľovi: | American Society of Clinical Oncology (ASCO), 2025. |
| Rok vydania: | 2025 |
| Predmety: | Male, Adult, Ronyons - Càncer - Recaiguda, Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia, Medizin, Nephrectomy, Quimioteràpia combinada, Disease-Free Survival, DISEASES::Neoplasms::Neoplastic Processes::Neoplasm Recurrence, Local, ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias urológicas::neoplasias renales, Double-Blind Method, ENFERMEDADES::neoplasias::neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias urológicas::neoplasias renales::carcinoma de células renales, Medicaments antineoplàstics - Ús terapèutic - Efectes secundaris, Antineoplastic Combined Chemotherapy Protocols, DISEASES::Chemically-Induced Disorders::Drug-Related Side Effects and Adverse Reactions, Humans, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Surgical Procedures, Operative::Urogenital Surgical Procedures::Urologic Surgical Procedures::Nephrectomy, DISEASES::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Urologic Neoplasms::Kidney Neoplasms, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::tratamiento combinado::quimioterapia adyuvante, Carcinoma, Renal Cell, Aged, Aged, 80 and over, Other subheadings::Other subheadings::Other subheadings::/drug therapy, Ronyons - Càncer - Cirurgia, ENFERMEDADES::trastornos inducidos químicamente::efectos colaterales y reacciones adversas relacionados con medicamentos, DISEASES::Neoplasms::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Urologic Neoplasms::Kidney Neoplasms::Carcinoma, Renal Cell, ORIGINAL REPORTS, Middle Aged, Ipilimumab, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Combined Modality Therapy::Chemotherapy, Adjuvant, Kidney Neoplasms, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::intervenciones quirúrgicas::procedimientos quirúrgicos urogenitales::procedimientos quirúrgicos urológicos::nefrectomía, Nivolumab, Chemotherapy, Adjuvant, ENFERMEDADES::neoplasias::procesos neoplásicos::recurrencia neoplásica local, Ronyons - Càncer - Tractament, Female, Neoplasm Recurrence, Local |
| Popis: | PURPOSE CheckMate 914 is a two-part, randomized phase III trial evaluating adjuvant nivolumab plus ipilimumab (part A) or adjuvant nivolumab monotherapy (part B) versus placebo in mutually exclusive populations of patients with localized renal cell carcinoma (RCC) at high risk of postnephrectomy recurrence. Part A showed no disease-free survival (DFS) benefit for adjuvant nivolumab plus ipilimumab versus placebo. We report results from part B. METHODS Patients were randomly assigned (2:1:1) to nivolumab (240 mg once every 2 weeks for up to 12 doses), placebo, or nivolumab (240 mg once every 2 weeks for up to 12 doses) plus ipilimumab (1 mg/kg once every 6 weeks for up to four doses). The planned treatment duration was 24 weeks (approximately 5.5 months). The primary end point was DFS per blinded independent central review (BICR) for nivolumab versus placebo; safety was a secondary end point. RESULTS Overall, 825 patients were randomly assigned to nivolumab (n = 411), placebo (n = 208), or nivolumab plus ipilimumab (n = 206). With a median follow-up of 27.0 months (range, 18.0-42.4), the primary end point of improved DFS per BICR with nivolumab versus placebo was not met (hazard ratio [HR], 0.87 [95% CI, 0.62 to 1.21]; P = .40); the median DFS was not reached in either arm, and 18-month DFS rates were 78.4% versus 75.4%. The HR for DFS per investigator was 0.80 (95% CI, 0.58 to 1.12; P = .19). Grade 3-4 all-cause adverse events (AEs) occurred in 17.2%, 15.0%, and 28.9% of patients with nivolumab, placebo, and nivolumab plus ipilimumab, respectively. Any-grade treatment-related AEs led to discontinuation in 9.6%, 1.0%, and 28.4%, respectively. CONCLUSION Part B of CheckMate 914 did not meet the primary end point of improved DFS for nivolumab versus placebo in patients with localized RCC at high risk of postnephrectomy recurrence. |
| Druh dokumentu: | Article Other literature type |
| Popis súboru: | application/pdf |
| Jazyk: | English |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.24.00773 |
| Prístupová URL adresa: | https://pubmed.ncbi.nlm.nih.gov/39303200 http://hdl.handle.net/11351/12750 |
| Rights: | CC BY NC ND URL: http://creativecommons.org/licenses/by-nc-nd/4.0/Creative Commons Attribution Non-Commercial No Derivatives 4.0 License: http://creativecommons.org/licenses/by-nc-nd/4.0/ (http://creativecommons.org/licenses/by-nc-nd/4.0/) |
| Prístupové číslo: | edsair.doi.dedup.....450289eaf0d04e38d2a437eaf06d52d5 |
| Databáza: | OpenAIRE |
Nájsť tento článok vo Web of Science | Abstrakt: | PURPOSE CheckMate 914 is a two-part, randomized phase III trial evaluating adjuvant nivolumab plus ipilimumab (part A) or adjuvant nivolumab monotherapy (part B) versus placebo in mutually exclusive populations of patients with localized renal cell carcinoma (RCC) at high risk of postnephrectomy recurrence. Part A showed no disease-free survival (DFS) benefit for adjuvant nivolumab plus ipilimumab versus placebo. We report results from part B. METHODS Patients were randomly assigned (2:1:1) to nivolumab (240 mg once every 2 weeks for up to 12 doses), placebo, or nivolumab (240 mg once every 2 weeks for up to 12 doses) plus ipilimumab (1 mg/kg once every 6 weeks for up to four doses). The planned treatment duration was 24 weeks (approximately 5.5 months). The primary end point was DFS per blinded independent central review (BICR) for nivolumab versus placebo; safety was a secondary end point. RESULTS Overall, 825 patients were randomly assigned to nivolumab (n = 411), placebo (n = 208), or nivolumab plus ipilimumab (n = 206). With a median follow-up of 27.0 months (range, 18.0-42.4), the primary end point of improved DFS per BICR with nivolumab versus placebo was not met (hazard ratio [HR], 0.87 [95% CI, 0.62 to 1.21]; P = .40); the median DFS was not reached in either arm, and 18-month DFS rates were 78.4% versus 75.4%. The HR for DFS per investigator was 0.80 (95% CI, 0.58 to 1.12; P = .19). Grade 3-4 all-cause adverse events (AEs) occurred in 17.2%, 15.0%, and 28.9% of patients with nivolumab, placebo, and nivolumab plus ipilimumab, respectively. Any-grade treatment-related AEs led to discontinuation in 9.6%, 1.0%, and 28.4%, respectively. CONCLUSION Part B of CheckMate 914 did not meet the primary end point of improved DFS for nivolumab versus placebo in patients with localized RCC at high risk of postnephrectomy recurrence. |
|---|---|
| ISSN: | 15277755 0732183X |
| DOI: | 10.1200/jco.24.00773 |