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- Check4 days agoChange DetectedThe website has been updated to version 2.10.0, adding 4 more interventions/treatments and noting that the study now has 3 locations.SummaryDifference0.5%
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- Check11 days agoChange DetectedThe website has been updated to Revision v2.9.7 from v2.9.6.SummaryDifference0.1%
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- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus Genetics related topics: Melanoma MedlinePlus related topics: Melanoma Genetic and Rare Diseases Information Center resources: Neuroendocrine Tumor Neuroepithelioma FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Non-Randomized Interventional Model : Parallel Assignment Interventional Model Description: Six patients are enrolled in each arm. If clinical benefit is observed, each arm will be expanded to enroll a total of 20 patients. Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : B: Pembrolizumab (Prednisolone >10 mg) Intravenous infusion of pembrolizumab 2 mg/kg every third week for up to two years. Drug : Pembrolizumab Injection [Keytruda] Alone Experimental : C: Ipilimumab/nivolumab (Prednisolone 11-25 mg) Intravenous infusion of ipilimumab 3 mg/kg and nivolumab 1 mg/kg four times every three weeks in the induction phase and nivolumab 480 mg every four weeks in the maintenance phase for up to two years. Drug : Ipilimumab Injection [Yervoy] In combination with nivolumab. Drug : Nivolumab Injection [Opdivo] In combination with ipilimumab. Experimental : D: Ipilimumab/nivolumab (Prednisolone >25 mg) Intravenous infusion of ipilimumab 3 mg/kg and nivolumab 1 mg/kg four times every three weeks in the induction phase and nivolumab 480 mg every four weeks in the maintenance phase for up to two years. Drug : Ipilimumab Injection [Yervoy] In combination with nivolumab. Drug : Nivolumab Injection [Opdivo] In combination with ipilimumab. Experimental : E: BRAF/MEK -> ipi/nivo (prednisolone >10 mg) Induction treatment with BRAF/MEK inhibitors (either the combination of encorafenib/binimetinib or dabrafenib/trametinib) orally for 28 days followed by intravenous infusion of ipilimumab 3 mg/kg and nivolumab 1 mg/kg four times every three weeks in the induction phase and nivolumab 480 mg every four weeks in the maintenance phase for up to two years. Drug : Ipilimumab Injection [Yervoy] In combination with nivolumab. Drug : Nivolumab Injection [Opdivo] In combination with ipilimumab. Drug : Encorafenib In combination with binimetinib Drug : Binimetinib In combination with encorafenib Drug : Dabrafenib In combination with dabrafenib Drug : Trametinib In combination with trametinib Primary Outcome Measures Outcome Measure Measure Description Time Frame 6 months progression-free survival rate Proportion of patients who did not progress or die within 6 months from commencing study treatment. 6 months 6 months overall survival rate Proportion of patients who did not die within 6 months from commencing study treatment. 6 months Secondary Outcome Measures Outcome Measure Measure Description Time Frame Overall progression-free survival Time from commencing study treatment to the date of progression or death. 4 years Overall survival Time from commencing study treatment to the date of death from any cause. 4 years Overall response rate Proportion of patients with an overall complete or partial response according to modified RECIST 1.1. 4 years Extracranial response rate Proportion of patients with an overall complete or partial response in extracranial lesions according to modified RECIST 1.1. 4 years Intracranial response rate Proportion of patients with an overall complete or partial response in intracranial lesions according to modified RECIST 1.1. 4 years Intracranial clinical benefit rate Proportion of patients with an overall complete, partial response or stable disease > 6 months according to modified RECIST 1.1. 4 years Blood and tissue biomarkers of response and progression Correlation of the baseline PD-L1 status, immune markers, genomics and other biomarkers in tumour tissue and blood with complete or partial response and at subsequent disease progressionanalyses of potential specific biomarkers predictive of response or progression. 5 years Keywords Provided by Inge Marie Svane, Herlev Hospital Immune therapy checkpoint inhibitor pembrolizumab ipilimumab nivolumab steroid brain metastasis BRAF inhibitor MEK inhibitor Additional Relevant MeSH Terms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Skin Neoplasms Neoplasms by Site Skin Diseases Melanoma Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors Enzyme Inhibitors Pembrolizumab Nivolumab Ipilimumab Trametinib DabrafenibSummaryDifference41%
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