2026-04-14T04:25:15Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/127502025-05-04T02:55:38Zcom_2072_378070com_2072_378040col_2072_378092

00925njm 22002777a 4500 dc Bex, Axel author Russo, Paul author Tomita, Yoshihiko author Cutuli, Hernan Javier author Rojas, Carlos author Motzer, Robert author Suárez, Cristina author 2025-03-12T08:17:35Z 2025-03-12T08:17:35Z 2024 2025-01-10 Adjuvant nivolumab; Localized renal cell carcinoma; Nephrectomy Nivolumab adjuvant; Carcinoma de cèl·lules renals localitzat; Nefrectomia Nivolumab adyuvante; Carcinoma de células renales localizado; Nefrectomía 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. Trial registration: ClinicalTrials.gov NCT03138512. Ronyons - Càncer - Tractament Ronyons - Càncer - Recaiguda Quimioteràpia combinada Ronyons - Càncer - Cirurgia Medicaments antineoplàstics - Ús terapèutic - Efectes secundaris DISEASES::Neoplasms::Neoplastic Processes::Neoplasm Recurrence, Local ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Combined Modality Therapy::Chemotherapy, Adjuvant 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 Other subheadings::Other subheadings::Other subheadings::/drug therapy DISEASES::Chemically-Induced Disorders::Drug-Related Side Effects and Adverse Reactions DISEASES::Neoplasms::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Urologic Neoplasms::Kidney Neoplasms::Carcinoma, Renal Cell ENFERMEDADES::neoplasias::procesos neoplásicos::recurrencia neoplásica local TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::tratamiento combinado::quimioterapia adyuvante TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::intervenciones quirúrgicas::procedimientos quirúrgicos urogenitales::procedimientos quirúrgicos urológicos::nefrectomía ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias urológicas::neoplasias renales Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia ENFERMEDADES::trastornos inducidos químicamente::efectos colaterales y reacciones adversas relacionados con medicamentos ENFERMEDADES::neoplasias::neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias urológicas::neoplasias renales::carcinoma de células renales 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