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- Check4 days agoChange DetectedThe study has been updated to version v2.10.0, replacing the previous version v2.9.7.SummaryDifference0.2%
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- Check32 days agoChange DetectedThe recent change in the webpage value from 'Show more Show more Revision: v2.9.0' to 'Show less MedlinePlus Genetics related topics: Melanoma MedlinePlus related topics: Melanoma Genetic and Rare Diseases Information Center resources: Neuroendocrine Tumor Neuroepithelioma Drug Information available for: Cabozantinib Pembrolizumab FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : N/A Interventional Model : Single Group Assignment Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Cabozantinib and pembrolizumab Cabozantinib will be administered in the tablet form, at three dose levels: 40, 20 and 60 mg per day. Pembrolizumab will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks. Drug : Cabozantinib Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs). Cabozantinib will be administered in the tablet form, at three dose levels: 40, 20 and 60 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle. Other Names: XL184 COMETRIQ™ Cabometyx® Drug : Pembrolizumab Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib. Other Names: Keytruda Primary Outcome Measures Outcome Measure Measure Description Time Frame Phase 1: Incidence of dose limiting toxicities using CTCAE, Version 4.03 All adverse events (AEs )will be considered in DLT assessment unless an event is clearly unrelated to trial treatment. The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 will be used. Initiation of treatment up to 2 years Phase 2: Best overall response rate (ORR) (complete response (CR) + partial response (PR)) per RECIST v1.1 Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 will be used to determine ORR. Initiation of treatment up to 2 years Secondary Outcome Measures Outcome Measure Measure Description Time Frame Determine disease control rate (DCR) according to RECIST v1.1 criteria DCR defined as the percentage of patients achieving CR+PR +SD Initiation of treatment up to 2 years Radiologic progression-free survival (PFS) per RECIST v1.1 PFS is defined as the time between the first dose of study therapy and the earliest date of progression or death (participants who have neither progressed nor died will be censored at the most recent last-known-alive date). Initiation of treatment up to 2 years Summarize overall survival (OS) with the method of Kaplan-Meier OS is defined as defined as the time between the first dose of study therapy and death (participants who have not died will be censored at the most recent last-known-alive date). Initiation of treatment up to 2 years 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 Pembrolizumab Plan to Share Individual Participant Data (IPD)? No Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Revision: v2.9.1SummaryDifference16%
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