دورية أكاديمية
أعرض في EDS

Phase Ib/II trial testing combined radiofrequency ablation and ipilimumab in uveal melanoma (SECIRA-UM).

التفاصيل البيبلوغرافية
العنوان: Phase Ib/II trial testing combined radiofrequency ablation and ipilimumab in uveal melanoma (SECIRA-UM).
المؤلفون: Rozeman EA; Departments of Medical Oncology., Prevoo W; Radiology, The Netherlands Cancer Institute (NKI), Amsterdam., Meier MAJ; Radiology, The Netherlands Cancer Institute (NKI), Amsterdam., Sikorska K; Department of Biometrics., Van TM; Division of Molecular Oncology and Immunology., van de Wiel BA; Department of Pathology., van der Wal JE; Department of Pathology., Mallo HA; Departments of Medical Oncology., Grijpink-Ongering LG; Department of Biometrics., Broeks A; Core Facility Molecular Pathology and Biobanking, NKI, Amsterdam, The Netherlands., Lalezari F; Radiology, The Netherlands Cancer Institute (NKI), Amsterdam., Reeves J; NanoString Technologies, Seattle, Washington, USA., Warren S; NanoString Technologies, Seattle, Washington, USA., van Thienen JV; Departments of Medical Oncology., van Tinteren H; Department of Biometrics., Haanen JBAG; Departments of Medical Oncology., Kapiteijn E; Department of Medical Oncology, LUMC, Leiden, The Netherlands., Blank CU; Departments of Medical Oncology.
المصدر: Melanoma research [Melanoma Res] 2020 Jun; Vol. 30 (3), pp. 252-260.
نوع المنشور: Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Lippincott Williams & Wilkins Country of Publication: England NLM ID: 9109623 Publication Model: Print Cited Medium: Internet ISSN: 1473-5636 (Electronic) Linking ISSN: 09608931 NLM ISO Abbreviation: Melanoma Res Subsets: MEDLINE
أسماء مطبوعة: Publication: London : Lippincott Williams & Wilkins
Original Publication: Oxford, UK : Rapid Communications of Oxford, 1991-
مواضيع طبية MeSH: Antineoplastic Agents, Immunological/*therapeutic use , Ipilimumab/*therapeutic use , Liver Neoplasms/*secondary , Liver Neoplasms/*therapy , Melanoma/*therapy , Radiofrequency Ablation/*methods , Uveal Neoplasms/*therapy, Adult ; Aged ; Combined Modality Therapy/methods ; Female ; Humans ; Male ; Melanoma/pathology ; Middle Aged ; Progression-Free Survival ; Uveal Neoplasms/pathology
مستخلص: Approximately, 50% of patients with uveal melanoma develop distant metastasis for which no standard therapy is established. In contrast to cutaneous melanoma, the anti-CTLA-4 antibody ipilimumab showed no clinical activity in uveal melanoma. Liver directed therapies improve local control, but fail to show overall survival (OS) benefit. Preclinical experiments demonstrated that radiofrequency ablation (RFA) induced durable responses in combination with anti-CTLA-4. The aim of this phase Ib/II study was to assess safety and efficacy of RFA plus ipilimumab in uveal melanoma. Patients underwent RFA of one liver lesion and subsequently received four courses ipilimumab 0.3, 3 or 10 mg/kg every 3 weeks in a 3 + 3 design. Primary endpoints were safety in terms of dose limiting toxicities per cohort to define the recommended phase II dose (RP2D) in the phase Ib part and confirmed the objective response rate and disease control rate (DCR) of non-RFA lesions in the phase II part. Secondary endpoints were progression-free survival (PFS) and OS. Ipilimumab 10 mg/kg + RFA was initially defined as the RP2D. However, after 19 patients, the study was amended to adjust the RP2D to ipilimumab 3 mg/kg + RFA, because 47% of patients treated with 10 mg/kg had developed grade 3 colitis. In the 3 mg/kg cohort, also 19 patients have been treated. Immunotherapy-related grade ≥3 adverse events were observed in 53% of patients in the 10 mg/kg cohort versus 32% in the 3 mg/kg cohort. No confirmed objective responses were observed; the confirmed DCR was 5% in the 10 mg/kg cohort and 11% in the 3 mg/kg cohort. Median PFS was 3 months and comparable for both cohorts, median OS was 14.2 months for the 10 mg/kg cohort versus 9.7 months for the 3 mg/kg cohort. Combining RFA with ipilimumab 3 mg/kg was well tolerated, but showed very limited clinical activity in uveal melanoma.
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المشرفين على المادة: 0 (Antineoplastic Agents, Immunological)
0 (Ipilimumab)
SCR Disease Name: Uveal melanoma
تواريخ الأحداث: Date Created: 20200103 Date Completed: 20210528 Latest Revision: 20210528
رمز التحديث: 20240628
DOI: 10.1097/CMR.0000000000000653
PMID: 31895753
قاعدة البيانات: MEDLINE
الوصف
تدمد:1473-5636
DOI:10.1097/CMR.0000000000000653