Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial
| العنوان: | Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial |
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| المؤلفون: | Mazhar Ajaz, Laurent Mortier, Inge Marie Svane, Ivan Marquez-Rodas, Thomas Eigentler, Jennifer Lord-Bessen, Paolo A. Ascierto, Elena Grigoryeva, Dirk Schadendorf, Caroline Robert, Linda Rollin, Jacopo Pigozzo, Nicolas Meyer, Michael Smylie, Rene Gonzalez, Alexander M. Menzies, Piotr Rutkowski, Céleste Lebbé, Abdel Saci |
| المصدر: | Journal of Clinical Oncology Lebbé, C, Meyer, N, Mortier, L, Marquez-Rodas, I, Robert, C, Rutkowski, P, Menzies, A M, Eigentler, T, Ascierto, P A, Smylie, M, Schadendorf, D, Ajaz, M, Svane, I M, Gonzalez, R, Rollin, L, Lord-Bessen, J, Saci, A, Grigoryeva, E & Pigozzo, J 2019, ' Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma : Results From the Phase IIIb/IV CheckMate 511 Trial ', Journal of Clinical Oncology, vol. 37, no. 11, pp. 867-875 . https://doi.org/10.1200/JCO.18.01998Test |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | 0301 basic medicine, Male, Cancer Research, Skin Neoplasms, Time Factors, Medizin, Gastroenterology, law.invention, 0302 clinical medicine, Antineoplastic Agents, Immunological, Randomized controlled trial, law, Skin Neoplasms/drug therapy, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, Melanoma/drug therapy, Ipilimumab/administration & dosage, Melanoma, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols/administration & dosage, Middle Aged, Progression-Free Survival, 3. Good health, Nivolumab/administration & dosage, Nivolumab, Oncology, 030220 oncology & carcinogenesis, Disease Progression, Female, Rapid Communication, medicine.drug, Adult, medicine.medical_specialty, Ipilimumab, Drug Administration Schedule, 03 medical and health sciences, Young Adult, Antineoplastic Agents, Immunological/administration & dosage, Double-Blind Method, Internal medicine, medicine, Humans, Dosing, Progression-free survival, Adverse effect, Aged, Neoplasm Staging, business.industry, Clinical trial, 030104 developmental biology, business |
| الوصف: | PURPOSE Nivolumab 1 mg/kg plus ipilimumab 3 mg/kg (NIVO1+IPI3) is approved for first-line treatment of patients with advanced melanoma in several countries. We conducted a phase IIIb/IV study (CheckMate 511) to determine if nivolumab 3 mg/kg plus ipilimumab 1 mg/kg (NIVO3+IPI1) improves the safety profile of the combination. PATIENTS AND METHODS Patients (N = 360) age 18 years or older with previously untreated, unresectable stage III or IV melanoma were randomly assigned 1:1 to NIVO3+IPI1 or NIVO1+IPI3 once every 3 weeks for four doses. After 6 weeks, all patients received NIVO 480 mg once every 4 weeks until disease progression or unacceptable toxicity. The primary end point was a comparison of the incidence of treatment-related grade 3 to 5 adverse events (AEs) between groups. Secondary end points included descriptive analyses of objective response rate, progression-free survival, and overall survival. The study was not designed to formally demonstrate noninferiority of NIVO3+IPI1 to NIVO1+IPI3 for efficacy end points. RESULTS At a minimum follow-up of 12 months, incidence of treatment-related grade 3 to 5 AEs was 34% with NIVO3+IPI1 versus 48% with NIVO1+IPI3 ( P = .006). In descriptive analyses, objective response rate was 45.6% in the NIVO3+IPI1 group and 50.6% in the NIVO1+IPI3 group, with complete responses in 15.0% and 13.5% of patients, respectively. Median progression-free survival was 9.9 months in the NIVO3+IPI1 group and 8.9 months in the NIVO1+IPI3 group. Median overall survival was not reached in either group. CONCLUSION The CheckMate 511 study met its primary end point, demonstrating a significantly lower incidence of treatment-related grade 3-5 AEs with NIVO3+IPI1 versus NIVO1+IPI3. Descriptive analyses showed that there were no meaningful differences between the groups for any efficacy end point, although longer follow up may help to better characterize efficacy outcomes. |
| وصف الملف: | application/pdf |
| تدمد: | 1527-7755 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7100d36b125a105d0de169d7144e1e3eTest https://pubmed.ncbi.nlm.nih.gov/30811280Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....7100d36b125a105d0de169d7144e1e3e |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15277755 |
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