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
Copyright policy )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
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.
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
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
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